Laminaria for preinduction cervical ripening. Intracervical Foley catheter balloon vs. prostaglandin in preinduction cervical ripening. [Cervical ripening : comparison of three methods. Preliminary results of a randomized prospective study]. Laminaria tents or vaginal prostaglandins for cervical ripening. A comparative trial. A comparison of vaginally administered misoprostol with extra-amniotic saline solution infusion for cervical ripening and labor induction. Cervical ripening with prostaglandin gel and hygroscopic dilators. Preinduction cervical ripening with the Foley catheter and saline infusion vs. cervical dinoprostone. Preinduction cervical ripening: prostaglandin E2 gel vs hygroscopic mechanical dilator. A randomized trial of misoprostol versus extra-amniotic sodium chloride infusion with oxytocin for induction of labor. A randomized trial of extra-amniotic saline infusion versus laminaria for cervical ripening. Preinduction cervical ripening techniques compared. A comparison of Lamicel and prostaglandin E2 vaginal gel for cervical ripening before induction of labor. Extra-amniotic prostaglandin E2 gel vs. amniotomy for elective induction of labour. Pre-induction cervical ripening: a randomized comparison of two methods. Combining medical and mechanical methods of cervical ripening. Does it increase the likelihood of successful induction of labor? Lamicel does not promote induction of labour. A randomized controlled study. A randomized trial of misoprostol and extra-amniotic saline infusion for cervical ripening and labor induction. Pre-induction cervical ripening: transcervical foley catheter versus intravaginal misoprostol. Randomised trial of intravaginal misoprostol and intracervical Foley catheter for cervical ripening and induction of labour. Medical and mechanical methods for cervical ripening. Low dose intravaginal misoprostol versus intracervical baloon catheter for pre-induction cervical ripening. A prospective, randomized comparison of Foley catheter insertion versus intracervical prostaglandin E2 gel for preinduction cervical ripening. Cervical ripening: a randomized comparison between intravaginal misoprostol and an intracervical balloon catheter combined with intravaginal dinoprostone. A randomized controlled trial comparing vaginal misoprostol versus Foley catheter plus oxytocin for labor induction. Hygroscopic cervical dilators and prostaglandin E2 gel for preinduction cervical ripening. A randomized, prospective comparison. Induction of labour at term in primigravidae with low Bishop's score: a comparison of three methods. A randomized comparison of prostaglandin E2, oxytocin, and the double-balloon device in inducing labor. A randomized trial comparing vaginal misoprostol versus Foley catheter with concurrent oxytocin for labor induction in nulliparous women. A randomized trial of extra-amniotic saline infusion plus intracervical Foley catheter balloon versus prostaglandin E2 vaginal gel for ripening the cervix and inducing labor in patients with unfavorable cervices. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. Induction of labor with three different techniques at 41 weeks of gestation or spontaneous follow-up until 42 weeks in women with definitely unfavorable cervical scores. Synthetic laminaria tent for cervical ripening. Preinduction cervical ripening. A randomized trial of intravaginal misoprostol alone vs. a combination of transcervical Foley balloon and intravaginal misoprostol. A randomized clinical trial comparing vaginal misoprostol versus cervical Foley plus oral misoprostol for cervical ripening and labor induction. Extra-amniotic saline, laminaria, or prostaglandin E(2) gel for labor induction with unfavorable cervix: a randomized controlled trial. Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening. A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. Role of the cervix in the induction of labor. A prospective randomized evaluation of a hygroscopic cervical dilator, Dilapan, in the preinduction ripening of patients undergoing induction of labor. Trial of extra amniotic saline infusion with oxytocin versus prostaglandin E2 pessary for induction of labor. Extraamniotic saline infusion is promising in preparing the cervix for induction of labor. A randomized comparison of transcervical Foley catheter to intravaginal misoprostol for preinduction cervical ripening. A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction. Extra-amniotic saline infusion versus extra-amniotic prostaglandin F2alpha for cervical ripening and induction of labor. A randomized trial of prostaglandin E2 gel and extra-amniotic saline infusion with high dose oxytocin for cervical ripening. Induction of labour by balloon catheter with extra-amniotic saline infusion (BCEAS): a randomised comparison with PGE2 vaginal pessaries. Randomized trial of Dilapan and Laminaria as cervical ripening agents before induction of labor. A comparison of three preinduction cervical priming methods: prostaglandin E2 gel, Dilapan S rods and Estradiol gel. Comparison of prostaglandin E2 tablets or Foley catheter for labour induction in grand multiparas. Cervical ripening and induction of labor with misoprostol, dinoprostone gel, and a Foley catheter: a randomized trial of 3 techniques. Cervical ripening and induction of labor with intravaginal misoprostol and Foley catheter cervical traction. Cervical ripening: randomized comparison of intravaginal prostaglandin E2 gel with prostaglandin E2 gel plus laminaria tents. Preinduction cervical ripening: a comparison of intracervical prostaglandin E2 gel versus the Foley catheter. Preinduction use of laminaria for the unripe cervix. Cervical ripening before induction of labour in patients with an unfavourable cervix: a comparative randomized study of the Atad Ripener Device, prostaglandin E2 vaginal pessary, and prostaglandin E2 intracervical gel.
A controlled, randomized double-blind protocol was used to test the safety and efficacy of Laminaria japonica as a preinduction cervical ripening agent. A 2-day induction with amniotomy on day 2 was allowed. Forty-eight patients were studied including 22 controls. Though laminaria resulted in consistent cervical ripening, it was no better than the control in improving the rate of successful induction. Additionally, the induction time was no shorter with laminaria. There were no demonstrable infections or other adverse sequelae following use of laminaria. For a standard 2-day induction protocol laminaria offered no clear advantage. The aim of this study is to compare the effectiveness of the intracervical Foley balloon catheter and 3 mg prostaglandin E(2) tablet(s) in preinduction cervical ripening.
                Ninety women referred to the maternity clinic for induction of labor with a Bishop score of less than or equal to 5 were randomized to receive an intracervical Foley catheter or prostaglandin E(2) tablets. The primary measured outcome was ripening of the cervix as measured with the Bishop score.
                There were no differences in mean Bishop scores between the prostaglandin and the Foley catheter groups. Bishop scores (mean+/-S.D.) after ripening were 6.6+/-0.80 and 6.7+/-0.86 for the Foley catheter and prostaglandin groups, respectively (P=0.54). The Foley catheter group showed a statistically shorter time to ripening compared with the prostaglandin group (3.4+/-2.1 and 6.5+/-3.2 h, respectively (P=0.001). There was no statistically significant difference in induction time (4.8+/-1.8 h and 5.3+/-2.4 h, respectively (P=0.36).
                There are no differences in preinduction cervical ripening efficacy between prostaglandin E(2) and the Foley catheter, but the Foley catheter has the advantage of ripening an unfavorable cervix in a shorter time. The authors report the preliminary results of a randomised prospective study begun in April 1992 at the maternity unit of the Caen Regional Hospital group. The aim of the study was to compare the efficacy and tolerability of three methods of cervical ripening in patients at term in whom there was an indication for the induction of labour while local conditions were unfavourable (Bishop score less than 6). In the first group, patients received an intracervical instillation of prostaglandins E2 (Prepidil), in accordance with the usual method of the department. In the patients of the second group, an intracervical Foley catheter with its balloon inflated to 50 cc was inserted and left under traction for 12 hours. Management of patients in the third group consisted of an extraamniotic injection of prostaglandins E2 via a Foley catheter previously inserted into the cervix and the balloon of which was also inflated with 50 cc of sterile water and which was left in place for 12 hours. Regardless of the method, each patient could undergo 3 ripening procedures separated by 24 hour intervals, provided the Bishop score did not reach 6. These results, which concern the first 184 patients enrolled in the protocol show the superior efficacy of the catheter + Prepidil method as compared with the other two (75% success rate after ripening as compared with 50% in each of the other two groups) as well as that intracervical Prepidil is equally effective in terms of success/failure as an intracervical catheter alone.(ABSTRACT TRUNCATED AT 250 WORDS) Laminaria tents and vaginal prostaglandin E2 were used to ripen the cervix in a randomly selected group of 20 patients in whom induction of labour was indicated and the Bishop score was less than 5. In the 14 patients who failed to go into labour both methods improved the Bishop score, but the laminaria tents were significantly (P less than 0,02) more effective cervical dilators. The use of laminaria tents in advocated in selected cases. The purpose of this study was to compare intravaginal misoprostol with extra-amniotic saline solution infusion with concomitant oxytocin for cervical ripening and labor induction in viable pregnancies.
                Two hundred women with indications for labor induction and unfavorable cervices were assigned randomly to vaginal misoprostol or extra-amniotic saline solution infusion. Twenty-five micrograms of misoprostol was administered every 4 hours up to six doses, followed by intravenous oxytocin administration. Patients who had received extra-amniotic saline solution infusion also received intravenous oxytocin along with a maximum 12-hour saline solution infusion through Foley catheters that were placed above the internal cervical os.
                One hundred women were randomly assigned to misoprostol, and 100 women were assigned randomly to extra-amniotic saline solution infusion. The average interval from start of induction to vaginal delivery was longer in the misoprostol group (1323.3 +/- 700.3 minutes) than in the extra-amniotic saline solution infusion group (970.4 +/- 502.7 minutes; P =.006, log transformed data). Abnormal fetal heart rate tracings were found in 30% of the patients who received misoprostol and in 19% of the patients who received extra-amniotic saline solution infusion (relative risk, 1.6; 95% CI, 1.0-2.4; P =.05). There was more tachysystole in the misoprostol group (8%) than in the extra-amniotic saline solution infusion group (1%; P =.02). There were no differences in the routes of deliveries or neonatal outcomes between groups.
                Extra-amniotic saline solution infusion with oxytocin administration appears more effective and is associated with fewer maternal complications than misoprostol for cervical ripening and labor induction. To study the effectiveness and morbidity of adding hygroscopic cervical dilators to prostaglandin gel for cervical ripening and labor induction.
                Patients of at least 34 weeks' gestation with a medical indication for induction of labor and with a modified Bishop score of 5 or less were randomized to receive either prostaglandin gel or prostaglandin gel with hygroscopic cervical dilators. Primary outcomes were time to delivery, change in cervical score, and infection. Secondary outcomes included cesarean delivery rate and deliveries before 24 hours of induction. Continuous variables were analyzed by Wilcoxon sum rank test and categorical data by chi-square or Fisher exact test, with P < 0.05 being significant.
                Seventeen patients were randomized to intracervical prostaglandin alone and 23 patients received intracervical prostaglandin plus hygroscopic dilators. No demographic differences were noted between the groups. After six hours of ripening, the combined group achieved a greater change in Bishop score (3.6 vs. 2.1, P = 0.007) and tended to have a shorter induction time (21.7 vs. 26.4 hours, P = 0.085). The combined therapy group had a higher infection rate than the prostaglandin-only group (59% vs. 12%, P = 0.003).
                Combining cervical dilators with prostaglandin gel provides more effective cervical ripening and a more rapid induction to delivery interval than prostaglandin alone but with a significant and prohibitive rate of infection. nan To evaluate the efficacy and safety of hygroscopic mechanical dilators (Dilapan) for ripening the pregnant cervix prior to induction of labour at or near term and to compare it with an intracervical PGE2 gel (Prepidil).
                One hundred and eighty-five women (69 nulliparae, 116 multiparae) at term with singleton pregnancies in cephalic presentation, who were scheduled for induction of labour in the labour ward at the National University Hospital, but had an unfavourable cervical score were randomized into 2 groups by random number table. In group 1 (Prepidil), 0.5 mg of PGE2 in 2.5 ml of triacetin gel was inserted into the endocervical canal. In women in group 2 (Dilapan) upto a maximum of 4 hygroscopic dilators were placed in the endocervical canal. If labour did not ensue at the end of 12 hours of ripening, the cervical score was assessed, amniotomy was performed and oxytocin commenced. Neonatal and obstetric outcome was compared, statistical analysis performed using Chi-square, and t-tests.
                Significantly more women in the group who received Dilapan for cervical ripening required amniotomy and oxytocin for induction of labour > 12 hours after priming compared with the group who received Prepidil (p < 0.001). Operative delivery for no progress and fetal distress respectively was similar in the 2 groups. The number of cases of hyperstimulation were higher in the Prepidil group but did not result in an increased incidence of operative deliveries for fetal distress. There was one neonatal death and one case of neonatal sepsis in the Dilapan group. Uterine rupture occurred in 1 woman who received Prepidil.
                Dilapan, a mechanical method of cervical ripening is as effective as the more widely accepted mode of ripening with an endocervical PGE2 gel in achieving vaginal delivery. Dilapan would be useful for cervical priming prior to induction of labour in places where prostaglandins are not available because of cost and the need for a cold chain. Our purpose was to compare the efficacy and safety of misoprostol and extra-amniotic sodium chloride infusion with oxytocin for induction of labor. Study Design: This randomized trial compared two methods of labor induction in women requiring cervical ripening. One hundred twenty-three women undergoing labor induction with a Bishop score < or =5 were randomly selected to receive either misoprostol, 50 microg intravaginally every 4 hours, or extra-amniotic sodium chloride infusion. The primary outcome variable was the time interval from induction to vaginal delivery.
                Sixty-one women received extra-amniotic sodium chloride infusion and 62 women received misoprostol. The mean time interval from the start of induction to vaginal delivery was 15.0 +/- 5.0 hours and 16.5 +/- 7.2 hours for the extra-amniotic infusion and misoprostol groups, respectively (P, not significant). The cesarean delivery rate was not significantly different between the 2 groups (32.8% for the extra-amniotic infusion group; 19.4% for the misoprostol group). Maternal and neonatal outcomes were similar between the 2 groups.
                Both methods of induction are equally efficacious and result in similar maternal and neonatal outcomes. To compare extra-amniotic saline infusion versus laminaria for cervical ripening and labor induction.
                Patients of at least 34 weeks' gestation with a Bishop score of 3 or less were randomized to either laminaria ripening for 6 hours or more followed by oxytocin induction versus initiation of extra-amniotic saline infusion at the start of oxytocin induction. Indications for induction included 41 weeks' gestation or greater, hypertensive disease, diabetes, oligohydramnios, suspect fetal growth, and nonreassuring fetal testing.
                There were no significant differences in maternal age, race, parity, gestational age, or indications for induction between the two groups (extra-amniotic saline infusion group, n = 26, laminaria group, n = 26). After only 3 hours of oxytocin induction, patients in the extra-amniotic saline infusion group achieved an identical distribution of Bishop scores compared with the patients in the laminaria group after 6 hours or more of pre-induction ripening as well as 3 hours of oxytocin induction. There were no differences in rates of cesarean delivery (extra-amniotic saline infusion 35%, laminaria 35%), infectious complications, or neonatal outcomes between the two groups. The induction-to-delivery interval (+/- standard deviation) was significantly shortened with extra-amniotic saline infusion (extra-amniotic saline infusion 12.9 +/- 5.7 hours versus laminaria 16.9 +/- 7.1 hours, P = .03). In addition, fewer cesarean deliveries were performed for failed inductions (cervix less than 5 cm dilated) in the extra-amniotic saline infusion group (one of 26 versus six of 26, P = .049).
                Extra-amniotic saline infusion offers potential advantages over the use of laminaria. Extra-amniotic saline infusion saves a significant amount of time both by obviating the need for pre-induction cervical ripening and in shortening the induction-to-delivery interval. Also, fewer patients required cesarean delivery for failed induction of labor with extra-amniotic saline infusion. To assess the clinical efficacy of pharmacologic, mechanical and combination techniques of cervical ripening.
                From March 1997 to August 1998, all cervical-ripening patients at Lehigh Valley Hospital were randomly assigned to three groups: intravaginal misoprostol, intracervical Foley catheter, or combination prostaglandin E2 (PGE2) gel and Foley catheter. Inclusion criteria included Bishop score < or = 5 and no contraindication to labor. The remaining delivery process was actively managed according to established guidelines. Multiple variables in perinatal outcome were analyzed, with the cesarean section rate and time from ripening to delivery as the main outcome variables.
                Of the 205 patients, 65 were randomized to the misoprostol group, 71 to the Foley group and 69 to the catheter-and-gel group. There were no differences between groups in delivery indications, maternal demographics, ultrasound findings, labor interventions, intrapartum times, mode of delivery, postpartum complications or neonatal outcomes. The misoprostol group demonstrated a higher rate of uterine tachysystole and required oxytocin less when compared to the two catheter groups.
                The higher rate of uterine tachysystole with misoprostol did not increase the cesarean section rate. The higher rate of oxytocin required by the two catheter groups did not increase the delivery time intervals. There appears to be no benefit to adding intracervical or intravaginal PGE2 gel to the intracervical Foley balloon. The misoprostol and catheter ripening techniques have similar safety and efficacy. The efficiency and safety of Lamicel, a new synthetic cervical ripening agent, were compared with those of intravaginal prostaglandin E2 gel in a group of 80 primigravid women about to undergo induction of labor. Lamicel caused less uterine activity and fetal distress than prostaglandin gel, although the induction-delivery intervals were similar in both groups. More normal deliveries occurred in the Lamicel group than in the prostaglandin group. It is suggested that Lamicel is a useful, efficient preinduction ripening agent that is safer than intravaginal prostaglandin gel. A randomized study was performed to compare three methods of labour induction in 143 clinically normal women (43 nulliparas) at term: amniotomy with or without intravenous oxytocin, extra-amniotic prostaglandin (PG) E2 gel, and extra-amniotic PGE2 gel plus an indwelling catheter. The three methods appeared to be comparable in effect and all of them were perinatally safe. Thus, if preference is given to keeping the ovular sac intact during the early phase of induced labour, extra-amniotic PGE2 in viscous gel, either with or without an indwelling catheter,. can replace the classical induction technique. To compare two methods of pre-induction cervical ripening in a randomized clinical trial.
                A single intracervical prostaglandin E2 (PGE2) gel application was compared with a single insertion of hygroscopic dilators in 441 women at term with unfavorable cervical scores. Induction success was defined as entry into active labor within 6 hours of oxytocin infusion.
                There was no statistical difference in pre- or post-ripening cervical scores. In the group receiving hygroscopic dilators, only 28% entered the active phase of labor within 6 hours of oxytocin infusion compared with 45% (P < .001) in the PGE2 group. Thus, in this study, a change in cervical score did not directly predict induction success. There was a higher rate of postpartum endometritis (24 versus 14%; P = .007) and suspected neonatal infection (10 versus 5%; P = .03) in the dilator group.
                Pre-induction ripening by hygroscopic dilators and intracervical PGE2 was equivalent as measured by changes in the cervical score. The change in cervical score, however, was not predictive of successful induction, and PGE2 was more frequently associated with induction success. Hygroscopic dilators were associated with a higher incidence of postpartum maternal and neonatal infection because of a longer duration of labor. Hospital charges for intracervical PGE2 gel totaled $522 compared with $91 for the insertion of three dilators. To determine if combining two commonly used methods or cervical ripening (intracervical prostaglandin E2 [Pge2] gel and Foley balloon catheter) would result in a higher number of successful inductions and fewer cesarean sections when compared to PGE2 gel alone.
                Seventy-eight patients with unfavorable cervixes eligible for induction of labor were prospectively randomized to receive either one dose (0.5 mg) of PGE2 gel followed by insertion of a 24-French Foley catheter (group 1, 41 patients) or two doses of 0.5 mg of intracervical gel (group 2, 37 patients). Outcome parameters included change in Bishop score, number of failed inductions, rate of cesarean section, rate of uterine hyperstimulation and postpartum infection.
                Patients in group 1 had a significant increase in posttreatment Bishop scores (7.26 +/- 2.0 SD vs. 4.82 +/- 1.8 P = .0001) and fewer failed inductions (0 vs. 6, P = .009) when compared to patients in group 2. Abdominal delivery rates, uterine hyperstimulation and infections complications were not different between the two groups.
                The combination of the Foley balloon and prostaglandin gel significantly improved the Bishop score and led to fewer failed inductions, although it did not increase the vaginal delivery rate. Lamicel is a synthetic tent, which, when inserted in the cervical canal, dilates the cervix by osmosis. Lamicel as an adjunct to induction of labour with intravenous oxytocin or vaginal prostaglandin E2 has been examined in a randomized controlled trial. Ninety-one pregnant women with an unripe cervix participated in the study. No improvement in efficacy was observed in the Lamicel groups compared to the control groups, neither when induction of labour was performed with oxytocin nor with vaginal prostaglandin. To compare the cesarean rates in women undergoing induction of labor with unfavorable cervices who receive either misoprostol or extra-amniotic saline infusion.
                We assigned 250 women undergoing indicated induction of labor randomly to misoprostol (50 microg every 4 hours for three doses with or without oxytocin) or extra-amniotic saline infusion and oxytocin. Each eligible subject had a singleton gestation, vertex presentation, intact membranes, cervical dilation no more than 2 cm, and effacement no more than 50%.
                Two hundred forty-eight women were studied after two exclusions; 120 were assigned to misoprostol, and 128 to extra-amniotic saline infusion. This sample size ensured an 80% chance of detecting an intergroup difference in cesarean rates of at least two-fold. The groups were similar in age, race, parity, indication for induction, and gestational age. The extra-amniotic saline infusion group had a significantly lower median initial dilation; however, at 12 hours, this group was significantly more dilated. The groups also were similar in epidural use, chorioamnionitis rates, endometritis rates, birth weights, and neonatal outcomes. Overall, 23% of women underwent cesarean deliveries, 18% and 27% for the misoprostol and extra-amniotic saline infusion groups, respectively (P = .12). There were no significant differences in the median time to either vaginal or cesarean delivery between the two groups. Eighty-one percent of women were delivered in less than 24 hours from initiation of induction; 78% in the misoprostol group, and 84% in the extra-amniotic saline infusion group (P = .19).
                Both methods of labor induction appear to be equally effective in this group of women at high risk for cesarean delivery and prolonged induction of labor. The object of this study was to compare the effectiveness of the intravaginal Misoprostol and transcervical Foley catheters as pre-induction cervical ripening agents, to estimate the proportion of patients achieving vaginal delivery and to compare the complications of labour and foetal outcome between the two groups. The study was a prospective, randomised study of pregnant women, with singleton pregnancies who presented for antenatal care and delivery at the University College Hospital (UCH), Ibadan, Nigeria. Ninety-nine patients were invited to participate and ninety-six (96) agreed. No patient withdrew from the study. The patients were assigned by means of computer-generated random numbers to receive transcervical Foley catheters (Size 16F, with 30 ml balloon capacity) or 50 microg intravaginal Misoprostol (Cytotec tablet, Searle & Co., Chicago). Fifty (50) patients received intravaginal Misoprostol and Forty-six (46) received Transcervical Foley catheters. The proportions of nulliparous, primiparous and multiparous patients were 52, 20 and 28% in the misoprostol group and 43.5, 26.1 and 30.4%, respectively, in the Foley catheter group. The time to achieve a favourable cervical status was significantly shorter in the Misoprostol group, with 98.0% of the subjects attaining Bishop score > or = 6 within 6-12 hours of insertion of the study agent, in contrast to 69.0% of the subjects in the Foley catheters group (P<0.001). Thirteen (26.6%) and three (6.5%) patients in the Misoprostol and Foley catheters groups, respectively, went into labour while undergoing cervical ripening and all had uneventful vaginal deliveries (P<0.05). The induction-delivery interval did not differ significantly between the groups. The incidence of caesarean delivery was 6.0% in the Misoprostol group compared with 2.2% in the Foley catheter group (P=0.62). Instrumental vaginal delivery rates were similar in both groups. Overall, the mode of delivery did not differ significantly between the groups. The number of neonates with 1-minute Apgar score <7 did not differ significantly in both groups and no neonate had 5-minute Apgar score <7. Meconium stained liquor was noticed in 5 (Misoprostol) vs 2 (Foley catheters) patients in labour. None of the neonates had any features suggestive of meconium aspiration. Labour complications were mainly precipitate labour {2 (Misoprostol) vs 1 (Foley catheters) } and 1 patient with transient tachysystole (> or =6 contractions in 10 minutes for two consecutive 10-minute periods) in the Misoprostol group. Hyperstimulation was not noticed in any of the patients in either arm of the study groups. Intravaginal Misoprostol is as effective a pre-induction cervical ripening agent as transcervical Foley catheters, with added advantages of shorter duration of cervical ripening, reduced oxytocin requirement for induction of labour and greater acceptability to patients. The incidence of caesarean sections, other labour complications and the foetal outcome were similar with both methods. Induction of labour may be indicated despite an unripe cervix. The purpose of this study was to compare the safety and efficacy of intravaginal misoprostol and an intracervical Foley's balloon catheter for preinduction cervical ripening and labour induction. A total of 120 patients requiring indicated induction of labour with an unfavourable cervix (Bishop's score < or =4) were randomised prospectively to receive either 50 mug intravaginal misoprostol every 6 h for a maximum of two doses, or an intracervical Foley balloon catheter for 12 h followed by an intravenous oxytocin infusion. The two arms of the study were comparable with respect to maternal age, parity, gestational age, indication for induction, and initial Bishop's scores. There were significant change in the Bishop's score in the two groups (5.9 +/- 0.2 and 4.0 +/- 0.2, respectively, p < 0.001) but no inter group differences. Oxytocin induction or augmentation of labour occurred more in the catheter group (95%) than in the misoprostol group (43.3%) (p < 0.0001). Induction to delivery interval was significantly shorter in the misoprostol group than in the catheter group (8.7 +/- 2.4 vs 11.9 +/- 2.7 h p < 0.0001). There was no significant difference noted in the caesarean or other operative delivery rates among patients in the two treatment groups. There was a higher incidence of tachysystole and hyperstimulation in the misoprostol group than in the catheter group (p < 0.03). No differences were observed between groups for meconium passage, 1- or 5-min Apgar scores < 7 and admission into the neonatal intensive care unit. In conclusion, the maternal and perinatal outcomes in this study have shown no difference confirming the efficacy and safety of both methods, however we observe a decrease in the induction-to-delivery interval when misoprostol is used for this purpose. nan The efficacy and safety of low dose misoprostol as a ripening agent compared to the widely used balloon catheter in developing countries is undetermined.
                To compare the safety and efficacy of a low dose intravaginal misoprostol and intracervical Foley's catheter for cervical ripening.
                A prospective randomized controlled trial.
                Zonal General Hospital, Kwale, Nigeria from June 1, 1998 to May 30, 2001.
                Candidates for pre-induction cervical ripening were randomized to receive either 250 mcg of intravaginal misoprostol every four hours (n = 60) or intracervical Foley's catheter (n = 61).
                Failure to achieve cervical ripening within 24 hours, need for augmentation, maternal and foetal complications.
                Failure to achieve cervical ripening within two hours was reduced with misoprostol (Relative Risk [RR] 0.63, 95% Confidence Interval [CI] 0.43 - 0.92). Need for oxytocin augmentation was less in the misoprostol group (RR 0.76, 95% CI 0.64 to 0.91). No significant differences existed in rates for uterine hyperstimulation, Caesarean section, maternal and neonatal morbidity.
                Intravaginal misoprostol in a low dose was compared to intracervical balloon catheter for pre-induction ripening of the cervix. The objective of this study was to compare intracervical prostaglandin E2 gel with insertion of a Foley bulb for efficacy in preinduction cervical ripening.
                Women who came to the hospital for induction of labor with a Bishop score </=5 were randomly assigned to treatment with either prostaglandin E2 gel or a Foley bulb. Prostaglandin E2 gel was used according to the manufacturer's recommendation. The Foley group had a number 14 Foley catheter inserted, inflated, and placed on traction. Immediately after Foley bulb extrusion or 6 hours after prostaglandin E2 gel course completion, a dilute oxytocin solution was started if the patient was not in labor.
                Seventy-seven women were entered into the Foley group and 72 were entered into the prostaglandin E2 gel group. Both the Bishop score after preinduction ripening (6.5 vs 5.1, P <.001) and the change in Bishop score (3.5 vs 2.7, P =.015) were significantly higher in the Foley group. There were no differences between the groups in mode of delivery, infant weight, rate of hyperstimulation, shoulder dystocia, patient discomfort, epidural use, oxytocin use, or nonreassuring fetal heart rate patterns. The preinduction time (9.9 vs 17.2 hours, P <.001) and the total induction time (22.4 vs 30.4 hours, P <.001) were significantly shorter in the Foley group. Patient charges were 31% lower in the Foley group (P <.001).
                Use of the Foley catheter resulted in a higher postinduction Bishop score, a greater change in Bishop score, a shorter induction time, and lower patient charges than did intracervical prostaglandin E2 gel. Our purpose was to compare the efficacy of intravaginal misoprostol and intracervical Foley catheter/intravaginal dinoprostone for cervical ripening.
                Patients admitted for induction of labor were randomized to receive intravaginal misoprostol 25 microg every 4 hours or intracervical Foley catheter/intravaginal dinoprostone 4 mg every 4 hours. Patients not entering active labor and having ruptured membranes or arrest of dilatation received intravenous oxytocin.
                Sixty-five patients received Foley catheter/dinoprostone gel and 62 patients received misoprostol. The mean time until cervical ripening was less in the catheter/gel group (7.5 +/- 3.4 vs 12.0 +/- 5.9 hours, p < 0.01). The mean time until vaginal delivery was less in the catheter/gel group (17.4 +/- 6.9 vs 21.2 +/- 7.5 hours, p = 0.004). Among vaginal deliveries, more patients in the catheter/gel group delivered within 24 hours (90% vs 69%, p = 0.013).
                Intracervical Foley catheter/intravaginal dinoprostone was associated with more rapid cervical ripening, shorter induction to vaginal delivery interval, and greater number of vaginal deliveries within 24 hours. To compare effectiveness and safety of 25 microg vaginal misoprostol versus Foley catheter and oxytocin for cervical ripening and labor induction in pregnant women with unripe cervices.
                Randomized controlled trial.
                A public maternity in Recife, Brazil.
                A total of 240 pregnant women.
                Women with a term or post-term, live, singleton fetus in cephalic presentation, intact membranes, Bishop score <6, not in labor, medically indicated for labor induction. They were randomly divided in Group 1, where 119 women received 25 microg of intravaginal misoprostol every 6 hours for a maximum of four doses; and Group 2, where 121 women had a 14-F Foley catheter inserted into their cervical canal. Once past the internal os, the balloon was inflated. Intravenous oxytocin was initiated after the balloon was spontaneously extruded from the cervix or after 24 hours.
                There were no significant differences between the groups regarding baseline characteristics. Misoprostol was more effective in inducing labor than Foley catheter and oxytocin. Mean induction-to-vaginal delivery time with misoprostol was shorter (17.3 vs. 20.2 hours, p = 0.016). There were more vaginal deliveries in the misoprostol group at 12 (p < 0.001) and 18 (p = 0.007) hours, but the difference was no longer statistically significant at 24 and 48 hours. There were no significant differences in uterine contraction abnormalities, puerperal infection or neonatal outcomes.
                Vaginal misoprostol is more effective than and as safe as Foley catheter and oxytocin for induction of labor in term and post-term pregnancy. A randomized, prospective study compared the safety and efficacy of hygroscopic cervical dilators (36 patients) with intracervical prostaglandin E2 (PGE2) gel (38 patients) in preinduction cervical ripening. Maternal age, gestational age and parity were similar in both groups. Both groups had similar cervical Bishop scores upon admission. The change in the cervical score was 3.0 +/- 0.3 (mean +/- SEM) in the dilator group and 2.8 +/- 0.4 in the PGE2 group (P = .7). The mean length of time from amniotomy to delivery was similar in both groups (10.1 +/- 1.0 and 10.3 +/- 1.3 hours, respectively) (P = .9). The proportions of patients in each arm of the study undergoing cesarean section were similar. Eight cesarean sections (21.0%) were performed in the PGE2 group; seven (19.4%) were performed in the dilator group (P = .9). Maternal morbidity, five-minute Apgar scores and admissions to the neonatal intensive care unit were similar in the two groups. Because patients were required to stay in the labor-and-delivery unit for four to six hours of fetal monitoring after PGE2 application, the costs were higher in that group. The dilators and PGE2 gel appear comparable in efficacy as preinduction cervical ripening agents. The need to monitor patients receiving PGE2 gel, however, appears to favor the choice of the dilators from a cost and convenience perspective. To determine which of three methods of induction of labour at term in primigravidae with a low Bishop's score is effective and safe.
                Random allocation to Prostin E2 and amniotomy later (Group A); low amniotomy and oxytocin titration (Group B); and intra-cervical Foley balloon overnight followed next morning by low amniotomy and oxytocin titration (Group C).
                Primigravidae (n = 90) in the University Hospitals, Benin City, Nigeria.
                (i) Time taken to achieve 3 uterine contractions in 10 min; (ii) induction-delivery interval.
                The mean time interval between intervention and regular uterine contractions was shortest in Group C (A vs. C, P < 0.02; A vs. B, P < 0.02). The mean induction-delivery interval was shortest in Group C (11.1 h) followed by Group B (13.9 h) and Group C (17.9 h) P < 0.05-0.001.
                The induction-delivery interval was shortest when using a Foley catheter for cervical ripening followed by amniotomy and oxytocin titration. To compare the efficacy of three methods for ripening and dilating the unfavorable cervix for induction of labor.
                Pregnant women having an indication for induction of labor with a singleton vertex fetus, intact membranes, and Bishop score of no more than 4 were randomized to one of three induction methods: intravaginal prostaglandin (PG) E2 tablets (3 mg) followed by a second dose if labor did not start; continuous intravenous oxytocin drip; or the Atad Ripener Device, with inflation of both balloons and removal after 12 hours. For all patients, the cervix was assessed by the same investigator before induction and 12 hours later.
                Thirty subjects were included in the PGE2 group, 30 in the oxytocin group, and 35 in the Atad Ripener Device group. The postpartum course was comparable in all. The change in Bishop score in the PGE2 and Atad Ripener Device groups was significantly better than in the oxytocin group (median and range of 5[0-9] and 5[0-7], respectively, versus 2.5 [0-9]; P < .01). Cervical dilation more than 3 cm was more frequent in the Atad Ripener Device group compared with both the PGE2 and oxytocin groups (85.7 versus 50 and 23.3%, respectively; P < .01). The trial of induction failed in only two patients (5.7%) in the Atad Ripener Device group, compared with six (20%) in the PGE2 and 16 (53.3%) in the oxytocin groups (P < .001). Mean (+/- standard deviation) induction-to-delivery interval was 21.3 +/- 7.0 hours in the Atad Ripener Device group, 23.2 +/- 12.5 hours in the PGE2 group, and 28.2 +/- 14.7 hours in the oxytocin group. The success rate for vaginal delivery was significantly better in the Atad Ripener Device and PGE2 groups compared with the oxytocin group (77.1 and 70%, respectively, versus 26.7%; P < .01).
                The Atad Ripener Device had a significantly better success rate for cervical dilation and a lower failure rate than those for PGE2 and oxytocin. The PGE2 and Atad Ripener Device groups had better results than the oxytocin group in regard to Bishop score change and induction-to-delivery interval. The Atad Ripener Device may be a superior method for cervical ripening and labor induction in patients with unfavorable cervices. The objective of this study was to compare the efficacy and safety of intracervical Foley catheter with concurrent use of oxytocin versus vaginal misoprostol for labor induction in nulliparous women. Nulliparous women with Bishop score <6 who presented for labor induction were randomized to either 25 microg vaginal misoprostol every 4 hours followed by oxytocin, if indicated, or intracervical Foley catheter with simultaneous use of oxytocin. Among the 162 patients enrolled, 79 (49%) received misoprostol and 83 (51%) received Foley/oxytocin. We were unable to demonstrate a statistically significant difference between the misoprostol group and Foley/oxytocin group in the incidence of cesarean delivery (35% versus 29%; p = 0.37). The induction-to-delivery time was significantly shorter in the Foley/oxytocin group (18 versus 24 hours; p < 0.01). No differences in intrapartum complications, neonatal outcomes, or maternal morbidity were found. When compared with vaginal misoprostol, intracervical Foley catheter combined with oxytocin has a similar efficacy and safety profile for labor induction in nulliparous women. Foley/oxytocin results in a shorter induction-to-vaginal delivery time compared with misoprostol. To compare the efficacy of extra-amniotic saline solution infusion plus an intracervical Foley catheter balloon versus 2.85 mg prostaglandin (PG) E2 vaginal gel in ripening the cervix, inducing labor, and achieving vaginal delivery in patients at term with an unfavorable cervix.
                A randomized study of the two methods was performed in 112 patients with a Bishop score of 5 or less.
                Extra-amniotic saline infusion plus intracervical Foley catheter balloon was more effective than PGE2 vaginal gel in causing cervical ripening (relative risk [RR] 2.5965, 95% confidence interval [CI] 1.7277-3.9022, exact two-tailed P = .000001) and in inducing labor (RR 4.3333, 95% CI 1.7223-10.9026, exact two-tailed P = .0000181). However, the final delivery outcome was an equally high number of cesarean deliveries (26 of 56, or 46.4%) for both methods. Maternal and neonatal complications were minimal and not significantly different.
                Extra-amniotic saline infusion with a Foley catheter was more effective than 2.85 mg PGE2 vaginal gel in ripening the cervix and inducing labor. These advantages did not translate into a large number of vaginal deliveries, indicating that factors other than cervical ripening may be responsible for the high incidence of cesarean in patients with an unfavorable cervix. To compare the efficacy and patient satisfaction of three methods of labour induction (double balloon catheters, single balloon catheters and prostaglandin gel) in term nulliparous women with unfavourable cervices.
                Randomised controlled trial.
                A total of 330 nulliparous women with unfavourable cervices induced at term.
                Three cervical ripening study arms were used: double balloon catheter (107 women); 16F Foley catheter (110 women) and PGE(2) gel (2 mg) (113 women).
                Caesarean section, induction to delivery interval, adverse reactions and patient satisfaction.
                There was no difference in caesarean delivery rates between groups (double balloon 43%, single balloon 36%, PGE(2) 37%, P = 0.567). The induction to delivery interval was longer in the double balloon group (median 24.5; 95% CI 23.7, 30.6 hours) than the single balloon (23.2; 20.8, 25.8 hours) or PGE(2) (23.8; 21.7, 26.8 hours) (P = 0.043). Uterine hyperstimulation occurred in 14% of the PGE(2) group with none occurring with mechanical cervical ripening. Cord blood gases were worse in the PGE(2) group: median arterial pH double balloon 7.26 (range 7.03-7.40); single balloon 7.26 (7.05-7.44); PGE(2) 7.25 (6.91-7.41) (P = 0.050). Cervical ripening with the single balloon catheter was associated with significantly less pain (pain score > or =4: double balloon 55%, single balloon 36%, PGE(2) 63%, P < 0.001).
                Labour induction in nullipara with unfavourable cervices results in high caesarean delivery rates. Although all methods in this study had similar efficacy, the single balloon catheter offers the best combination of safety and patient comfort. To compare the obstetric outcome of induction of labor at 41 weeks and of follow-up until 42 weeks and induction if the patient has still not given birth at 42 weeks.
                Six hundred women at 287+/-1 days of gestation with definitely unfavorable cervical scores were randomized to labor induction (N=300) or spontaneous follow-up (N=300) with twice-weekly nonstress testing and amniotic fluid measurement and once-weekly biophysical scoring. The treatments used in the induction group were (1) vaginal administration of 50 microg misoprostol (n=100), (2) oxytocin induction (n=100), and (3) transcervical insertion of a Foley balloon (n=100). The primary outcome measures were the cesarean delivery rate, whether or not the normal hospital stay had to be extended, and the neonatal outcomes. Secondary outcome measure included number of emergency cesarean deliveries performed for abnormalities of the fetal heart rate (FHR).
                The abdominal delivery rate was 19.3% in the induction group and 22% in the follow-up group (p=0.4). The mean length of hospital stay in the two main groups was 1.4+/-0.8 days and 1.3+/-1 days, respectively (p=0.1). Significantly higher rates of macrosomia and shoulder dystocia were seen in the follow-up group (24.6 and 2.3%) than in the induction group (7.6%, p<0.001; 0.3%, p=0.03). Meconium-stained amniotic fluid and meconium aspiration syndrome were observed significantly less frequently in the induction group (9.3 and 1.3%) than in the follow-up group (20.3%, p<0.001; 4%, p=0.03). Rates of emergency abdominal delivery in response to worrying FHR traces, neonatal intensive care unit admission, and low umblical artery pH were similar in the two groups. There was one intrauterine fetal death in the follow-up group.
                Induction of labor at 41 weeks of gestation does not increase the cesarean delivery rate or cause a longer stay in hospital than follow-up until 42 weeks, and neonatal morbidity is also lower after induction. The efficacy and safety of a synthetic laminaria tent (Lamicel; Cabot) in ripening the cervix before induction of labour was compared with prostaglandin E2 (PGE2) oral tablets used intravaginally. Eighty patients were randomly assigned to use of the laminaria tent (N = 40) or PGE2 (N = 40). There were an equal number of primigravidas and multigravidas in each group. The only significant difference between the groups was the higher frequency of uterine hypertonicity (29 v. 5 : PGE2 v. tent) and consequent fetal distress (5 v. 1 : PGE2 v. tent) in the PGE2 group. However, the duration of labour was shorter in the PGE2 group than in the tent group (10, 14 h v. 11,61 h). These findings indicate that the synthetic laminaria tent is the preferred agent for cervical ripening in high-risk pregnancies and in developing countries. To determine if the addition of a mechanical ripening agent (transcervical Foley balloon) to a pharmacologic agent (intravaginal misoprostol) improves the efficiency of preinduction cervical ripening.
                Singleton patients with an indication for delivery, unfavorable cervix (Bishop score < or = 5) and no contraindication to labor were randomly assigned to two groups: misoprostol alone (25 micrograms intravaginally every 3 hours for no more than 12 hr) or combination therapy (25-French transcervical Foley balloon inflated to 50 mL of sterile water with identical intravaginal misoprostol dosing). All patients received a history and physical examination (including Bishop score), preripening ultrasound, electronic fetal heart rate and contraction monitoring (to rule out spontaneous labor and document fetal well-being). Multiple variables of perinatal outcome were analyzed, including the main outcome variables of ripening-to-delivery time and cesarean section rate.
                During August 1998 to August 1999, 81 patients were randomized, 40 to misoprostol alone and 41 to combination therapy. There were no differences between the groups with respect to maternal demographics, preripening Bishop score, maternal complications, intrapartum intervention or neonatal outcome. The misoprostol group spent longer periods of time in active labor, and there was a trend for the combination group to require oxytocin for longer intervals. These findings did not significantly affect the total ripening-to-delivery time or cesarean section rate which were similar for both groups.
                The addition of mechanical ripening with a transcervical Foley balloon to intravaginal misoprostol did not improve the efficiency of preinduction cervical ripening. Mechanical and pharmacologic cervical ripening agents appear to act independently rather than synergistically. We compared labor induced by vaginal misoprostol versus a supracervical Foley catheter and oral misoprostol. Singleton pregnancies at > or = 24 weeks' gestation were randomized to either an initial 25-microg dose of intravaginal misoprostol, followed by 50-microg intravaginal doses at 3- to 6-hour intervals, or a supracervical Foley balloon and 100 microg of oral misoprostol at 4- to 6-hour intervals. Primary outcome was time from induction to delivery. One hundred twenty-six women were randomized to vaginal misoprostol alone (group I) and 106 women to Foley and oral misoprostol (group II). The groups were similar in age, weight, gestational age, parity, indication for induction of labor, and oxytocin use. Cesarean delivery rates at 37% and cesarean indications were similar ( P = 0.25). The time from induction to delivery in group II (12.9 hours) was significantly shorter than that in group I (17.8 hours, P < 0.001). Uterine tachysystole occurred less often in the vaginal misoprostol group (21% versus 39%, P = 0.015). Compared with vaginal misoprostol, delivery within 24 hours was significantly more likely with a Foley balloon and oral misoprostol. The use of terbutaline and peripartum outcomes were similar in the two groups. To determine which of three methods of cervical ripening resulted in the lowest cesarean rate in women with unfavorable cervices and indications for labor induction.
                Consenting women with singleton gestations, vertex presentations, and unfavorable cervices (dilatation under 2 cm and effacement under 75%) were randomly assigned to laminaria and standard intravenous oxytocin, serial doses of intracervical prostaglandin (PG) E(2) gel (Prepidil, Pharmacia & Upjohn, Inc., Kalamazoo, MI) 0.5 microg every 6 hours for two doses followed by oxytocin if indicated, or extra-amniotic saline infusion and oxytocin.
                An interim analysis after recruitment of 321 subjects, 67% of the planned sample, found similar cesarean rates for the three groups (laminaria 36%; PGE(2) gel 33%; saline infusion 29%; P =.59); however, the mean randomization-to-delivery interval was significantly longer in the PGE(2) group. Stochastic curtailment, as part of the interim analysis, indicated a low likelihood of achieving a statistically significant difference in cesarean rates between PGE(2) gel and the other two groups. Therefore, we completed the study with saline infusion and laminaria. The saline infusion and laminaria groups had similar preinduction characteristics. The cesarean rates were similar (saline infusion 25.4% versus laminaria 30.3%; P =.32), but the mean interval from randomization to delivery was shorter in the saline infusion group (18.0 versus 21.5 hours, P =.002). There were no significant differences in selected maternal and neonatal morbidities.
                Cervical ripening with extra-amniotic saline infusion, PGE(2), or laminaria resulted in comparable cesarean rates in women with an unfavorable cervix and indications for labor induction. Extra-amniotic saline infusion had the shortest randomization-to-delivery interval without increasing maternal or neonatal morbidity. The success of induced labor depends on the degree of ripening of cervix. Pharmacological preparations are in widespread use for cervical ripening but are not free from side-effects and complications. Mechanical methods, i.e. the use of Foley catheter balloon, though effective have not gained much popularity because of the fear of infection. Therefore, this study has been conducted to prove the efficacy and safety of extraamniotic Foley catheter balloon and to compare it with intracervical prostaglandin E2 (PGE2) gel.
                The randomized prospective study was conducted in the Department of Obstetrics and Gynecology and Medical Microbiology of Nehru Hospital. Hundred women attending the labor ward for induction of labor were divided into two groups: Group A--Foley catheter, Group B--PGE2 gel. Cervical swabs before and after the insertion of ripening agents were taken for culture studies. Placental membranes were also sent for culture. Labor outcome, side-effects, and complications were compared in both the groups. The statistical methods used were Student's compared t-test, Chi-square test, and Wilcoxon-Mann-Whitney test.
                Foley catheter proved to be a very effective preinduction ripening agent for unfavorable cervix compared with PGE2 gel, as is evident by the mean Bishop score at 12 h (P<0.001). Preparation delivery interval was significantly shorter (P<0.05) in women who underwent cervical ripening with Foley catheter balloon than with the PGE2 gel. No clinical evidence of chorioamnionitis was present in both the groups.
                This study concludes that extraamniotic Foley catheter balloon is an effective, safe, simple, low-cost, reversible, non-pharmacological mechanical method of preinduction cervical ripening. To compare the efficacy and safety of induction of labour by vaginal application of dinoprostone or misoprostol or transcervical insertion of a balloon (Bard) catheter.
                A non-blinded, randomised, controlled trial.
                A tertiary level Swedish hospital.
                A total of 592 women who had undergone full-term pregnancies, not previously been subjected to a caesarean section, and required induction of labour for common, routine indications.
                Women were randomly assigned to induction of labour using intravaginal dinoprostone (2 mg once every 6 hours) or misoprostol (25 micrograms once every 4 hours) or a transcervical balloon catheter.
                The time interval between induction to delivery in general and vaginal delivery in particular, the mode of delivery, maternal and neonatal parameters of outcome.
                Of the 588 subjects included in the final intention-to-treat analysis, 191 were assigned to treatment with dinoprostone, 199 with misoprostol and 198 with the balloon catheter. The shortest mean induction-to-delivery interval was obtained with the catheter (12.9 hours versus 16.8 and 17.3 hours for dinoprostone and misoprostol, respectively). The efficacies of the two prostaglandins were similar. The maternal and neonatal outcomes associated with each of the three procedures were similar.
                Induction of labour with a transcervical balloon catheter is effective and safe and can be recommended as the first choice. The two prostaglandins, dinoprostone and misoprostol, were shown to be equally effective and safe, while misoprostol costs significantly less and is easier to store. A study on induction of labor was carried out to test the hypothesis that changing the cervix will enhance the effectiveness of induction of labor. Fifty pregnant women near term with Bishop scores of 4 or less were divided into 5 study groups, in which a 12-hour preparation phase procedure was carried out to produce cervical or myometrial changes. All women had continuous measurement of uterine activity by an extraovular catheter. The patients were divided into 1) control subjects, and into groups treated with 2) laminaria, 3) Foley catheter, 4) amniotomy, and 5) oxytocin infusion. These preparation techniques were used for 12 hours, after which rupture of membranes was carried out in all cases. Although all procedures significantly changed the cervix, none but oxytocin affected the induction-to-delivery interval. The authors concluded that when a study design rigidly controls for cervical Bishop score, timing of rupture of membranes, and oxytocin infusion rates, the cervical preparation alone will not enhance inducibility. Our purpose was to investigate the safety and efficacy of a synthetic intracervical hygroscopic dilator, Dilapan (Gynotech, Inc., Middlesex, N.J.), on ripening the cervix before medically indicated induction of labor.
                Two hundred forty patients with a Bishop score of < or = 4 were prospectively randomized to receive either preinduction synthetic hygroscopic dilators (n = 112) or no pretreatment (n = 128) before oxytocin induction.
                Compared with controls, the dilator group exhibited a significant change in median Bishop score, but there was no significant difference in length of labor (dilator 18.8 +/- 12.8 hours vs control 21.7 +/- 14.8 hours) or in the cesarean section rate (dilator 41/112 [36.6%] vs control 49/128 [38.3%]). Relative proportions of nulliparous and multiparous patients, infant weights, and cervical dilation at the time of cesarean section were not significantly different between groups. No adverse maternal or fetal effects could be attributed to use of the device.
                Preinduction cervical ripening with hygroscopic dilators does not shorten the length of labor or lower the cesarean section rate in patients undergoing induction of labor. To determine the effectiveness and safety of cost-effective extra-amniotic saline infusion (EASI) and simultaneous intravenous oxytocin infusion versus prostaglandin E2 vaginal pessary (PGE2) for induction of labor.
                Prospective randomized comparative study.
                Labor room at the Mother and Child Health Centre, PIMS, Islamabad from September 2000 to December 2001.
                Women with singleton alive pregnancies and Bishop score < or =6, requiring induction of labor at > or =37 weeks gestation were randomly assigned to induction either with PGE2 3 mg vaginal pessary in two doses 6 hourly or EASI for 12 hours with simultaneous intravenous oxytocin infusion. Artificial rupture of membranes was done 12 hours post-induction and oxytocin infusion started in PGE2. Main outcome measures were induction delivery interval and the mode of delivery. Secondary outcome measures were the change in modified Bishop score 6 hours postinduction and neonatal outcome in the two induction modes.
                After 4 exclusions, 100 women were recruited in each arm. Mean induction delivery interval was 11.1 and 14.3 hours (p=.00) in PGE2 and EASI respectively. The cesarean rate was 11% and 15% (p=0.4) in PGE2 and EASI respectively. Mean Bishop score at induction was 3.2 in PGE2 and 3.1 in EASI, while after 6 hours it was 4.8 and 6.8 (p=0.00) respectively. Mean APGAR scores at 1 and 10 minutes were identical that is 6.2 and 8.6 respectively.
                Both the modes of induction were equally safe and effective in terms of the mode of delivery and APGAR score. EASI, however, had more rapid cervical ripening and shorter induction delivery interval. The application of local prostaglandins before induction of labor in women with an unripe cervix is standard procedure in Sweden. Side effects include uterine hypertonus and occasionally fetal heart rate abnormalities. Failed ripening is reported in up to 25% of cases. A previous report of ripening of the cervix by use of extraamniotic physiologic saline infusion through a Foley catheter applied in the cervix claimed results superior to topical prostaglandins.
                To conduct a prospective randomized trial of extraamniotic saline infusion and intracervical application of dinoprost 0.5 mg on cervical ripening and outcome of labor.
                Eighty-five term singleton pregnant women with unripe cervices where induction of labor was indicated were randomized to prostaglandin or saline infusion after obtaining informed consent. Outcome variables were improvement of cervical score, induction delivery time and mode of delivery.
                The 42 women in the saline infusion group obtained significantly (p < or = 0.001) higher cervical scores and shorter induction delivery intervals (p < or = 0.005) than the 43 women in the prostaglandin group. Cases of unripe cervix after 24 hours were significantly (p < or = 0.01) fewer in the saline group. There were more Cesarean sections in the saline group, but this difference was not significant. Saline infusion did not induce uterine activity and oxytocin was given in every case after the expulsion of the catheter.
                In this study extraamniotic saline infusion was a more efficacious method for ripening of the cervix than intracervical prostaglandin. The absence of early painful contractions is an advantage, but effective stimulation of labor is required to effect delivery after maturation of the cervix. To compare the efficacy of intravaginal misoprostol tablets with transcervical Foley catheter for preinduction cervical ripening.
                Pregnant women who presented for induction of labor with unfavorable cervices (Bishop score less than 6) were assigned randomly to intravaginal misoprostol (50 microg tablet every 4 hours for a maximum of six doses) or 30-mL Foley catheter placed transcervically with maintenance of traction.
                Among 111 women, 53 were allocated to misoprostol and 58 to Foley bulb. Contractile abnormalities were more frequent in the misoprostol group (20.4%) than the Foley group (0%) (P <.001). No statistically significant differences were noted between groups in change in Bishop score, preinduction cervical ripening times, and total induction times. There were no statistically significant differences in mode of delivery or adverse neonatal outcomes. Uterine rupture occurred in one woman with two previous cesarean deliveries in the misoprostol group.
                Intravaginal misoprostol and transcervical Foley catheter are equivalent for cervical ripening. Uterine contractile abnormalities and meconium passage are more common with misoprostol. The purpose of this study was to determine the efficacy of combination intravaginal misoprostol and intracervical Foley catheter for prelabor cervical ripening.
                A prospective, randomized controlled trial was conducted. Women who were undergoing labor induction, with a singleton gestation >or=28 weeks and an unfavorable cervix (Bishop score <or=6), were assigned to one of three groups: (1) intravaginal misoprostol 25 mug every 3 hours, (2) intracervical 16F Foley catheter, or (3) combination misoprostol-Foley catheter.
                Among 146 patients, 49 patients were assigned to misoprostol, 54 patients were assigned to Foley catheter, and 43 patients were assigned to combination therapy. There was no difference in vaginal delivery rates (misoprostol, 63.3%; Foley, 57.4%; combination, 58.1%; P=.81). There were also no statistically significant differences in the interval between induction to active phase, active phase to delivery, or induction to delivery among the three groups.
                Intravaginal misoprostol and intracervical Foley catheter are comparable for preinduction cervical ripening. The combination of the two methods did not provide additional efficacy. To compare the effectiveness of extra-amniotic saline infusion versus extra-amniotic prostaglandin F2alpha for cervical ripening, induction of labor and achievement of vaginal delivery in patients with unfavorable cervices.
                A randomized trial of extra-amniotic saline infusion versus extra-amniotic prostaglandin F2alpha performed at Harare Central Hospital Maternity Unit, Zimbabwe. One hundred and sixty-four patients were recruited from those referred to Harare Central Hospital Maternity Unit who required induction of labor for either maternal or fetal indications.
                162 patients (extra-amniotic PgF2alpha group, N = 81; extra-amniotic saline infusion group, N = 81) had complete information. Two patients (one from each group) were lost to follow up. The demographic characteristics of the patients and the indications for induction were not statistically different. There was a marginally statistically significant difference in the change of Bishop Score in favor of the extra-amniotic saline infusion (4.0, S.D. = 1.4) as compared to (4.5, S.D. = 1.5) for extra-amniotic PgF2alpha (P value = 0.047). All other parameters showed no statistically significant differences. Maternal and fetal complications were minimal and not significantly different. Extra-amniotic saline infusion was however almost six times cheaper than PgF2alpha.
                Extra-amniotic saline infusion is as effective as PgF2alpha, safe, but much cheaper than PgF2alpha and should be seriously considered as a method of first choice in resource-poor settings. Our purpose was to compare the efficacy of extra-amniotic saline infusion plus high dose oxytocin with prostaglandin E2 intracervical gel (Dinoprostone) for preinduction cervical ripening.
                166 nulliparous women with term pregnancies, vertex presentation, intact membranes and a Bishop score < or = 4 referred for labor induction were randomly assigned to receive a 0.5 mg PGE2 intracervical gel and extra-amniotic saline infusion (EASI) plus high-dose oxytocin. Changes in the Bishop scores, labor progress, various labor end points and outcomes of labor were assessed. Data were analyzed using chi2 analysis or the Student t-test.
                151 women were studied after 15 exclusions, 75 were assigned to PGE2, and 76 to EASI. The groups were similar in age, race, indication for induction and gestational age. The EASI group had a significant improvement in Bishop score and greater dilation. The mean time to vaginal delivery was 11.4+/-4.8 hours and 18.9+/-6.4 hours for the EASI and PGE2 groups respectively (P=0.001). The cesarean delivery rate was not significantly different between the two groups (25% for the EASI group; 34.6% for the PGE2 group). The cesarean rate due to failure to progress, fetal labor intolerance, and maternal and neonatal outcomes were similar in the two groups.
                Preinduction cervical ripening with EASI plus high dose oxytocin resulted in greater changes in Bishop score, and shorter time to normal vaginal delivery than with PGE2 gel in nulliparous women, without increasing the cesarean rate due to failure to progress or fetal labor intolerance. A new method for induction of labour--balloon catheter with extra-amniotic saline infusion (BCEAS)--is evaluated in randomised comparison with prostaglandin E2 (PGE2) in vaginal pessaries.
                One-hundred and nine pregnant women with unfavourable cervices.
                The efficiency of inducing vaginal delivery and the level of 'disadvantages following induction of labour' (DisFIL scorings).
                Overall, BCEAS was less efficient inducing vaginal delivery than vaginal PGE2 (P < 0.01) because of a significant difference among parous women (P < 0.01). In the (larger) primiparous women group, and particularly in the subgroup of these having very low pelvic scores (Lange score, < or = 3), the efficiencies of the two methods were equal (P = 0.06) and P = 0.55, respectively). The levels of DisFIL scorings were not significantly different. However, higher rates of caesarean section followed BCEAS than PGE2 (29% and 10%, respectively; P < 0.05). Serious infectious complications were not recorded following BCEAS. No difference was apparent in the status of the neonates (judging from Apgar scores and umbilical artery pH and SBE). The women, delivering vaginally, commented the two methods equally favourably.
                BCEAS was less efficacious than vaginal PGE2 pessaries, though among primiparous women, especially those with very unfavourable cervices, the difference was not significant. Further refinements of the method are suggested. A randomized trial was conducted to evaluate the comparative effectiveness of Dilapan cervical dilators and Laminaria japonicum as cervical ripening agents before induction of labor at term. Patients with Bishop scores of 4 or less and a fetal or maternal indication for induction at 34 or more weeks' gestation were eligible for the study. The outcome variables of interest were Bishop score upon removal of the devices, number of devices used, induction-to-delivery time, and induction-to-complete dilatation time. In the Dilapan group, an average of 4.3 devices per patient was used, compared with 9.7 devices in the laminaria group (P less than .01). Among patients who eventually achieved complete dilatation, the mean (+/- SD) time for the Dilapan group was 10.8 +/- 6.1 hours, compared with 14.7 +/- 9.2 hours with laminaria. For women undergoing induction of labor at term with an unripe cervix, Dilapan appeared to be a preferable alternative to Laminaria japonicum because its use may result in a shorter induction-to-delivery interval with fewer devices required to obtain significant cervical ripening. The aim of the study was to evaluate the efficacy of three cervical priming methods. From January 1, 1994 to December 31, 1996 247 patients presenting an indication for induction of labor with an unripe cervix were randomly assigned to one of the following preinduction protocols: 0.5 mg of Prostaglandin E2 gel administered intracervically (n = 83), four hygroscopic Dilapan S rods applied intracervically (n = 82), and 150 mg of Estradiol gel administered intravaginally (n = 82). The inclusion criteria were the patient's informed consent, singleton pregnancy of more than 36 weeks, cephalic presentation, Bishop score < 5 points and reactive non-stress test. If the cervical maturation (Bishop score > or = 5, and/or Bishop score augmentation by 2 points) did not occur after 14 hours of priming, the case was considered a failure. In the opposite case the patient was induced by means of extraamniotic PGE2 administration. The mean gain in the Bishop score was 3.7 points in the PGE2 group 3.9 points in the Dilapan S group, and 2.8 points in the Estradiol group. 71 patients (85.5%) were successfully preinduced in the PGE2 group, 73 (89.0%) in the Dilapan S group, and 63 (76.8%) in the Estradiol group. Labor was induced by preinduction only in 23 patients (31.3%) of the PGE2 group in 17 (20.7%) of the Dilapan S group, and in 14 (17.1%) of the Estradiol group. The mean induction to delivery interval was 7 h 27 min in PGE2 group, 7 h 49 min in the Dilapan S group and 9 h 15 min in the Estradiol group. The Caesarean section rate was 24.4% in the PGE2 group, 10.5% in the Dilapan S group, and 24.4% in the Estradiol group. PGE2 gel and Dilapan S rods proved higher efficacy than Estradiol gel. The highest frequency of labor induced by preinduction only was in the PGE2 group. There were shorter induction to delivery intervals in the PGE2, and Dilapan S groups. The lowest Caesarean section rate was in the Dilapan S group. Neither serious side effects nor negative neonatal outcome were noted in either group. The efficacy, safety and outcome of prostaglandin (PG)E2 was compared with Foley catheter for labour induction in grand multiparous women. At a hospital in Jordan, 147 women with Bishop score < or = 5 were randomized to receive 3 mg PGE2 vaginal tablets (n = 75) or 50 mL intracervical Foley catheter (n = 72). The change in Bishop score was significantly higher in the PGE2 group than the catheter group, and time from induction to delivery was significantly shorter in the PGE2 group. Significantly more women needed oxytocin for labour augmentation in the catheter than the PGE2 group and fetal distress was significantly more frequent. For grand multiparas, PGE2 vaginal tablets may be preferable for ripening the cervix as well as for labour induction. The purpose of this study was to compare the efficacy of 3 different techniques of cervical ripening and induction.
                Patients who required cervical ripening and induction were randomized to one of 3 groups: (1) supracervical Foley catheter and intravaginal dinoprostone gel, (2) supracervical Foley catheter and 100 microg oral doses of misoprostol, or (3) serial 100-microg oral doses of misoprostol. Intravenous oxytocin was administered when a protraction disorder of labor was identified.
                There were 339 women randomized. There was no significant difference in the time from first intervention to delivery in the 3 groups (P =.546). In each group, a similar percentage of women required oxytocin (P =.103). The rates of cesarean delivery were equivalent among the groups (P =.722). Rates of tachysystole were high but statistically equivalent among the 3 groups. There were no significant differences in Apgar scores or umbilical artery pH.
                Oral 100 microg serial doses of misoprostol, with or without the use of a supracervical Foley catheter, were equivalent to the use of a supracervical Foley catheter and serial 4-mg doses of dinoprostone gel for cervical ripening and the induction of labor. nan The purpose of this study was to evaluate the efficacy of adding laminaria tents to sequential intravaginal prostaglandin E2 (PGE2) gel for cervical ripening. A prospective, randomized study was conducted from October 1994 to May 1995. Pregnant women with maternal or fetal indications for induction of labor at > or = 37 weeks gestation and a Bishop score of < or = 4 were eligible. Nineteen patients received laminaria tents in addition to 4 mg PGE2 gel, while 25 patients received PGE2 gel alone. After 4 hr, the laminaria tents were removed and the gel was continued in both groups at 4-hr intervals. Induction with oxytocin was initiated after a Bishop score of > or = 5 was achieved. The groups were comparable with respect to maternal age, parity, gestational age, reason for induction, and initial Bishop score. The addition of laminaria tents to sequential PGE2 gel did not statistically improve the time to a favorable cervix (control group 12.7 +/- 8.5 hr (95% CI, 9.1-16.3) and study group 10.9 +/- 7.1 hr (95% CI, 7.5-14.3) (P = 0.59). The 6-hr difference from the time of the initial PGE2 gel placement to delivery was not detected (control group 22.4 +/- 11.2 hr, 95% CI 17-27 and study group 23.4 +/- 13.1 hr, 95% CI 17-29.6 (P = 0.79). The combination approach of laminaria tents and PGE2 gel did not have a significant impact on the vaginal delivery rate, with 28.0% of patients in the control group and 26.3% of patients in the study group undergoing cesarean section (P = 0.90). Maternal and neonatal complications were rare in both groups. We had insufficient evidence to show that the addition of laminaria tents to PGE2 gel improved cervical ripening, the induction to delivery interval, or the cesarean section rate in patients at term undergoing induction of labor. Both prostaglandin E2 gel and an intracervical balloon catheter have been shown to be effective for cervical ripening. The purpose of this study is to compare the efficacy of intracervical prostaglandin E2 gel with an intracervical Foley catheter for preinduction cervical ripening.
                A randomized, prospective study was conducted in the Maternity Care Center at the Foothills Hospital at Calgary, Alberta, Canada. Patients with a Bishop score < or = 4 and meeting inclusion and exclusion criteria were included. Thirty patients were randomized to receive prostaglandin E2 gel and 36 to receive an intracervical Foley catheter on the evening before induction. Induction then proceeded the following morning by the preferred method of the attending physician.
                The groups were comparable with respect to maternal age, parity, gestational age, reason for induction, and initial Bishop scores. Both groups had a significant change in Bishop score (4.1 +/- 0.4 and 4.8 +/- 0.5, respectively, p < 0.001); however, there was no significant difference between the groups. There was no significant difference in side effect profile, intrapartum complications, or delivery mode. Six cesarean sections (17.6%) were performed in the Foley group and seven (25%) in the prostaglandin E2 gel group (not significant). The induction-to-delivery interval was 16.0 +/- 1.7 hours in the Foley group and 21.5 +/- 3.2 hours in the prostaglandin E2 gel group (p = 0.014). Apgar scores, cord gases, and neonatal birth weight showed no difference between the groups.
                This study has shown that for preinduction cervical ripening there is no difference in efficacy between intracervical prostaglandin E2 gel or an intracervical Foley catheter. nan One hundred and nineteen women with singleton pregnancy and cephalic presentation requiring induction of labour in the presence of an unfavourable cervix (Bishop score < or = 4) were studied. Five patients were excluded because of failure to comply with the protocol. Cervical ripening was carried out using 3 different methods; 36 used the Atad Ripener Device, 39 received 0.5 mg PGE2 intracervical gel and 39 received at least one 3 mg PGE2 intravaginal pessary. There were no differences in the demographic characteristics and the indications for induction. Five patients developed complications during the ripening period necessitating intervention; 3 required emergency Caesarean section and 2 delivered vaginally. Although statistically there were no differences among the 3 methods of cervical ripening, the power of the study is probably not large enough to show the differences. The PGE2 pessary appears to be more effective with 68% of patients either going into labour during cervical ripening or succeeding in the cervical ripening compared to around 50% in the Atad and PGE2 gel groups. The vaginal delivery rate was 87.2% in the pessary group compared to 72.2% in the Atad group and 84.6% in the gel group. The duration of labour was also shorter in the pessary group with 73.5% delivered within 24 hours compared to 57.7% in the Atad group and 57.6% in the gel group. Although the results of the Atad device seem to be inferior, the risk of uterine hyperstimulation from the use of the device is probably lower than that of the PGE2 and may therefore be preferable in women with fetuses at high risk of fetal hypoxia.
Induction of labour using mechanical methods results in similar caesarean section rates as prostaglandins, for a lower risk of hyperstimulation. Mechanical methods do not increase the overall number of women not delivered within 24 hours, however the proportion of multiparous women who did not achieve vaginal delivery within 24 hours was higher when compared with vaginal PGE2. Compared with oxytocin, mechanical methods reduce the risk of caesarean section.