Double-blind evaluation of ritodrine sustained release for oral maintenance of tocolysis after active preterm labour. Ritodrine in oral maintenance of tocolysis after active preterm labor: randomized controlled trial. A prospective randomized comparison of oral terbutaline and magnesium oxide for the maintenance of tocolysis. The clinical efficacy of oral tocolytic therapy. Randomized comparison of oral terbutaline and ritodrine for preventing recurrent preterm labor. Randomized trial of oral indomethacin and terbutaline sulfate for the long-term suppression of preterm labor. Oral tocolysis with magnesium chloride: a randomized controlled prospective clinical trial. Oral terbutaline after parenteral tocolysis: a randomized, double-blind, placebo-controlled trial. The efficacy of oral terbutaline after intravenous tocolysis. Oral terbutaline in the outpatient management of preterm labor. Terbutaline sulfate in the prevention of recurrence of premature labor. Oral ritodrine maintenance in the treatment of preterm labor.
To evaluate the effect of ritodrine sustained release capsules for maintaining uterine quiescence after successful treatment of active preterm labour.
                Multicentre placebo-controlled trial.
                Five teaching hospitals in the Netherlands.
                Women (n = 95) at less than 35 weeks of gestation in whom active preterm labour had been stopped with intravenous ritodrine.
                Women received either two 40 mg ritodrine sustained release capsules (n = 50) or identical placebo capsules (n = 45) three times a day for seven days.
                The proportion of women who received another course of active treatment was significantly smaller with the sustained release than with placebo (1 of 50 versus 11 of 45: P = 0.003) as was the number delivering because of preterm labour during treatment (0 of 50 versus 4 of 45: P = 0.04). There were no other significant differences between the two groups.
                Maintenance treatment with ritodrine sustained release capsules after arrest of preterm labour reduces the risk of recurrences of preterm labour that necessitate treatment or precipitate delivery. To assess the efficacy of oral ritodrine in the form of sustained-release capsules for maintenance of uterine quiescence after successful treatment of threatened preterm labor.
                We randomized 120 women with singleton pregnancy who were successfully treated for threatened preterm labor before 34 completed weeks to receive either maintenance tocolysis with two 40 mg ritodrine sustained release capsules three times a day (study group, n=62) or no treatment (control group, n=58) for three days. The primary outcome measure was the recurrent episode of threatened preterm labor within 72 hours, which was defined as regular palpable uterine contractions and change in cervical effacement or cervical dilatation on clinical examination. Secondary outcome measures included the incidence of preterm birth, neonatal adverse outcomes, and maternal side effects.
                There was no difference in the frequency of recurrent episodes of threatened preterm labor requiring another course of intravenous treatment between the study (8/62) and control (6/58) group of women (P=0.879). No differences were found between the study and control groups in any of the predefined secondary outcome measures, ie, delivery before 37 weeks (13/62 vs 7/58, respectively; P=0.288), delivery before 34 weeks (3/62 vs 1/58, respectively; P=0.682) and birth weight (3037-/+573 g vs 3223-/+423 g, respectively, P=0.862). There were more reported maternal side effects in the study group than in control group (47/62 vs 23/58, respectively; P(<0.001).
                Additional maintenance ritodrine therapy was unnecessary in women with singleton pregnancy who had an episode of threatened preterm labor successfully treated with intravenous tocolytic therapy.
                ClinicalTrials.gov Identifier: NCT00290173. We compared oral magnesium oxide with oral terbutaline sulfate in a prospective, randomized manner to determine efficacy and side effects. Preterm labor patients whose labor was arrested with parenteral tocolysis were randomized to oral tocolysis with either magnesium oxide, 200 mg every 3 to 4 hours (n = 23), or terbutaline, 2.5 to 5 mg every 3 to 4 hours (n = 27). The number of patients who were delivered of infants before 36 weeks' gestation was similar between groups (18.5% receiving terbutaline versus 17.4% receiving magnesium). At least one side effect occurred in 81.5% of patients in the terbutaline group and 47.8% in the magnesium group (p less than 0.01). Finally, the cost for 1 day of magnesium (20 cents) is approximately one third the cost of terbutaline (56 cents). These data suggest that oral magnesium oxide is as effective as terbutaline for the maintenance of tocolysis, with fewer side effects and at a lower cost. Our purpose was to determine whether maintenance oral tocolytic therapy after preterm labor stabilization decreases uterine activity, reduces the rate of recurrent preterm labor and subsequent preterm birth, or improves neonatal outcome.
                Women with documented idiopathic preterm labor stabilized with acute tocolytic therapy were randomized to three groups: placebo, terbutaline 5 mg, or magnesium chloride 128 mg, all given orally every 4 hours. Patients and providers were blinded to group assignment. All subjects were enrolled in a comprehensive system of preterm birth prevention that included preterm labor education, weekly clinic visits, home uterine contraction assessment, daily phone contact, and 24-hour perinatal nurse access.
                Of the 248 patients who were randomized, 39 were delivered before discharge and 4 were lost to follow-up, leaving 205 for final analysis: 68 placebo, 72 terbutaline, and 65 magnesium. The terbutaline group had significantly more side effects than the placebo group did. All groups had otherwise similar perinatal outcomes when confounding variables were controlled for. Overall, the three groups had a preterm birth rate < 37 weeks of 55.6% delivery, < 34 weeks of 15.6%, a 20.4% rate of newborn intensive care unit admission, and a mean neonatal length of stay of 6.3 days.
                Maintenance oral tocolytic therapy did not decrease uterine activity, reduce the rate of recurrent preterm labor or preterm birth, or improve perinatal outcome. Overall improvement in perinatal outcome may be achieved with a comprehensive program of preterm birth prevention without the use of maintenance oral tocolytic therapy. We compared oral ritodrine and terbutaline for the prevention of recurrent preterm labor. Women between 20 and 35 weeks' gestation who successfully completed a course of intravenous tocolysis were eligible for inclusion. One hundred two patients were randomized to oral ritodrine (20 mg every four hours) or oral terbutaline (5 mg every four hours). The groups showed no significant differences with respect to recognized risk factors for preterm labor or prognostic factors for the failure of tocolysis. Initial treatment failures occurred more frequently in the ritodrine group (nine vs. two, P = .0527). There were no statistically significant differences in the treatment results or frequency of side effects. We conclude that ritodrine appears to be less effective than terbutaline upon the initiation of oral therapy and that oral ritodrine and terbutaline are equivalent in safety and efficacy when used on a long-term basis for preventing recurrent preterm labor. Our purpose was to determine the efficacy and safety of long-term oral tocolysis with indomethacin or terbutaline sulfate.
                Seventy-one patients at 26 to 32 weeks' gestation admitted for preterm labor were prospectively randomized to receive oral indomethacin or terbutaline sulfate after successful intravenous tocolysis. Patients were monitored weekly for cervical change, maternal side effects, amniotic fluid volume, and constriction of the fetal ductus arteriosus. Patients receiving indomethacin were converted to terbutaline at 34 weeks or with the occurrence of fetal ductal constriction or oligohydramnios.
                Of 71 patients randomized six were excluded after randomization. Thirty-three patients were randomized to indomethacin and thirty-two to terbutaline. There were no differences in the percentage of patients achieving 34 weeks of gestation. No differences in neonatal outcome were noted. Nine (27%) fetuses receiving indomethacin had constriction of the fetal ductus arteriosus, and 13 (38%) had oligohydramnios. Most patients on terbutaline reported beta-mimetic side effects (53%), but only one required discontinuation of therapy.
                Both indomethacin and terbutaline sulfate are effective tocolytics, but major fetal side effects are common with long-term indomethacin use. A prospective randomized clinical trial was conducted to assess the efficacy and safety of enteric-coated magnesium chloride (SLOW MAG) as an oral tocolytic agent. Seventy-five patients between 24 and 34 weeks' gestation who were treated with intravenous magnesium sulfate for a first episode of preterm labor were enrolled. After a 12-hour contraction-free period on intravenous therapy, patients were randomized by sealed envelope to one of three groups: group 1, SLOW MAG (535 mg every 4 hours); group 2, oral ritodrine (20 mg every 4 hours); or group 3, no therapy (control). Patients receiving oral therapy were treated until delivery or completion of 36 weeks' gestation. No difference was found between groups with respect to time gained with the use of oral therapy or number completing 36 weeks' gestation. Therapy with enteric-coated magnesium chloride was associated with significantly fewer side effects (20%) as compared with ritodrine (48%) (p less than 0.01). Our results suggest that compared with ritodrine, enteric-coated magnesium chloride is as effective in prolonging pregnancy and preventing recurrent preterm labor. However, neither enteric-coated magnesium chloride nor ritodrine appeared to be any more effective in the prevention of preterm delivery than observation alone. Our purpose was to determine whether oral terbutaline, used after successful intravenous tocolysis, will prolong pregnancy and prevent recurrent preterm labor.
                After successful intravenous tocolysis, 203 women with preterm labor at 24 weeks' to 34 weeks 6 days' gestation were randomized to terbutaline (5 mg orally, every 4 hours) or placebo until 37 weeks' gestation. Women with recurrent preterm labor were treated with intravenous magnesium sulfate; if tocolysis was successful, they continued with the initial study medication. The primary outcome was the percentage delivered of their infants within 1 week of beginning oral tocolytic therapy. Latency, recurrent preterm labor, and maternal and neonatal outcomes were also assessed.
                Pregnancy outcome data were available in 200 women. There were no differences seen between the two groups in the incidence of delivery at 1 week (18% vs 24%, 95% confidence interval 0.44 to 1.29). In addition, there were no differences regarding median latency, mean gestational age at delivery, or the incidence of recurrent preterm labor (20% vs 16%, 95% confidence interval 0.64 to 2.71). Post hoc evaluation of 96 women enrolled before 32 weeks' gestation suggested pregnancy prolongation with maintenance oral terbutaline (p < 0.01).
                Maintenance oral terbutaline therapy initiated at 24 weeks' to 34 weeks 6 days' gestation after successful parenteral tocolysis is not associated with pregnancy prolongation or a reduction in the incidence of recurrent preterm labor. Our purpose was to investigate in a prospective, randomized study the efficacy of oral terbutaline after successful intravenous tocolysis in reducing preterm birth.
                Patients between 28 and 35 weeks' gestation with uterine contractions and change in cervical examination were treated with intravenous magnesium sulfate for 12 to 24 hours. After successful tocolysis patients were approached for study participation and randomized to receive either oral terbutaline or no therapy. The dose of terbutaline was individualized to achieve a maternal pulse > 100 beats/min, and terbutaline was continued until 36 completed weeks of gestation. Recurrent preterm labor (contractions with change in cervical examination) for either group was treated with intravenous magnesium sulfate, and subsequent treatment was based on the previous randomization.
                Fifty-five patients were enrolled (28 terbutaline, 27 no oral tocolytic). No difference was found between groups with respect to time gained (4.0 +/- 2.7 vs 4.6 +/- 3.1 weeks, p = 0.412), gestational age at delivery (35.6 +/- 2.7 vs 36.1 +/- 2.4 weeks, p = 0.562), > or = 37 weeks at delivery (nine vs 13, p = 0.291), recurrent preterm labor (10 vs four, p = 0.104), recurrent uterine contractions alone (five vs eight, p = 0.527), birth weight (2616 +/- 633 gm vs 2645 +/- 599 gm, p = 0.785), special care nursery admissions (eight vs six, p = 0.759), or neonatal respiratory distress syndrome (three vs two, p = 0.965).
                The use of oral terbutaline after successful parenteral tocolysis failed to reduce the rate of preterm birth. Our purpose was to prove our hypothesis that once preterm uterine contractions and/or labor is controlled with intravenous tocolysis, oral terbutaline, as a maintenance drug, does not prolong pregnancy.
                Before discharge, 184 patients between 24 and 35 completed weeks' gestation were prospectively randomized to continued bed rest either with or without oral terbutaline. Assignment was made with stratification into four groups: group 1, those patients with a Bishop score > or = 5 with oral terbutaline (n = 50); group 2, those with a Bishop score > or = 5 without oral terbutaline (n = 53); group 3, those with a Bishop score < 5 with oral terbutaline (n = 41); group 4, those with a Bishop score < 5 without oral terbutaline (n = 40). Oral terbutaline was discontinued at 37 completed weeks.
                No statistically significant differences were found in the number of readmissions, the number of unscheduled hospital visits, and the neonatal outcomes among the four groups. The gestational age at delivery and percent of deliveries at > or = 37 weeks were not significantly different when group 1 was compared with group 2 and group 3 was compared with group 4.
                Oral terbutaline maintenance does not improve pregnancy outcome in patients who have had initial successful intravenous tocolysis. Forty-six patients in premature labor were initially successfully treated with ethanol infusion. Twenty-three of these patients were then given prolonged oral terbutaline sulfate therapy until 38 weeks' gestation, and the remaining 23 patients were given placebo. The treated group gained significantly more time in gestation than the placebo group (P < .05), although the placebo group started with a higher Bishop score. In addition, idiopathic respiratory distress syndrome was seen significantly less often in the treated group. There was no perinatal mortality in either group. Seventy patients with preterm labor and intact membranes were initially treated with ritodrine hydrochloride to delay preterm delivery. Tocolysis beyond 24 hours was achieved in 59 patients. Fifty-five of the 59 patients were then placed on either oral ritodrine or placebo as maintenance therapy in a randomized double-blind manner. If preterm labor recurred, the sequence of intramuscular and then oral treatment was repeated. The number of days gained after initiation of intramuscular treatment was similar in both groups (oral ritodrine = 34 days, oral placebo = 36 days). In those 55 patients receiving oral treatment, there was a smaller number of relapses requiring repeat intramuscular treatment in the oral ritodrine group (1.11 in the ritodrine patient vs. 2.71 in the placebo patient, p less than 0.05), and the mean interval between beginning oral treatment and the first relapse/delivery was 5.8 days in the oral placebo group and 25.9 in those receiving oral ritodrine (p less than 0.05). Cardiovascular side effects, notably maternal tachycardia and palpitations were frequent but well tolerated. The results suggest that oral ritodrine maintenance will decrease the incidence of recurrent preterm labor in patients who have had initial successful tocolysis.
Available evidence does not support the use of oral betamimetics for maintenance therapy after threatened preterm labour.