The Collaborative Randomised Amnioinfusion for Meconium Project (CRAMP): 1. South Africa. The Collaborative Randomised Amnioinfusion for Meconium Project (CRAMP): 2. Zimbabwe. Meconium-stained amniotic fluid in labor: a randomized trial of prophylactic amniofusion. Amnioinfusion during labor complicated by particulate meconium-stained amniotic fluid decreases neonatal morbidity. Amnioinfusion for the prevention of the meconium aspiration syndrome. Prophylactic amnioinfusion in pregnancies complicated by thick meconium. Intrapartum amnioinfusion for meconium-stained liquor in developing countries. Prophylactic amnioinfusion during labor complicated by meconium: a preliminary report. Prophylactic amnioinfusion for meconium-stained amniotic fluid. Prophylactic amnioinfusion improves outcome of pregnancy complicated by thick meconium and oligohydramnios. Amnioinfusion in thick meconium.
To evaluate transcervical amnioinfusion for meconium stained amniotic fluid during labout.
                Multicentre randomised controlled trial.
                Four urban academic hospitals in South Africa. Obstetric surveillance included the use of electronic fetal heart rate monitoring in most cases.
                Women in labour at term with moderate or thick meconium staining of the amniotic fluid.
                Transcervical amnioinfusion of 800 mL saline at 15 mL per minute, followed by a maintenance infusion at 3 mL per minute. The control group received routine care. Blinding of the intervention was not possible.
                Caesarean section, meconium aspiration syndrome and perinatal mortality.
                Caesarean section rates were similar (amnioinfusion group 70/167 vs control group 68/159; RR 0.98, 95% CI 0.76-1.26). The incidence of meconium aspiration syndrome was lower than expected on the basis of previous studies (4/162 vs 6/163; RR 0.67, 95% CI 0.19-2.33). There were no perinatal deaths. There were no significant differences between any of the subsidiary outcomes.
                This study concurred with three previous trials which found no effect of amnioinfusion for meconium-stained amniotic fluid on caesarean section rate, though the pooled data from all identified trials to date show a significant reduction. The findings with respect to meconium aspiration syndrome were inconclusive in this study alone because of the small number of babies affected, but the point estimate of the relative risk was consistent with the finding of a significant reduction in previous studies and with the Zimbabwe arm (CRAMP 2) of this study. Pooled data clearly support the use of amnioinfusion for meconium stained amniotic fluid to reduce the incidence of meconium aspiration syndrome. To evaluate transcervical amnioinfusion for meconium stained amniotic fluid during labour.
                Multicentre randomised controlled trial.
                A large urban academic hospital. Electronic fetal heart rate monitoring was not used.
                Women in labour at term with moderate or thick meconium staining of the amniotic fluid.
                Transcervical amnioinfusion of 500 mL saline over 30 minutes, then 500 mL at 30 drops per minute. The control group received routine care. Blinding of the intervention was not possible.
                Caesarean section, meconium aspiration syndrome and perinatal mortality.
                There was no difference in risk for caesarean section in the two groups (amnioinfusion 9.5% vs control 12.3%; RR 0.84, 95% CI 0.53-1.32). Meconium aspiration syndrome was significantly less frequent in the amnioinfusion group (3.1% vs 12.8%; RR 0.24, 95% CI 0.12-0.48), and there was a trend towards fewer perinatal deaths (1.2% vs 3.6%; RR 0.34, 95% CI 0.11-1.06).
                Amnioinfusion is technically feasible in a developing country situation with limited intrapartum facilities. In this study amnioinfusion for meconium stained amniotic fluid was associated with striking improvements in perinatal outcome. To investigate the effect of amnioinfusion in women with meconium-stained amniotic fluid on the rate of cesarian sections and on neonatal morbidity.
                A randomized controlled trial. A total of 206 women with meconium-stained amniotic fluid were assigned to receive amnioinfusion via two-way catheter or no amnioinfusion (control group). The catheter was inserted and other treatment was the same in both groups.
                Amnioinfusion decreased the rate of cesarian sections for fetal distress (RR 0.23, 95% CI 0.07-0.79) and increased mean pH at birth (7.24+/-0.1 versus 7.21+/-0.1, P<0.05). It also decreased the frequency of variable fetal heart rate decelerations (RR 0.74, 95% CI 0.59-0.92), and of meconium below the vocal cords in neonates (RR 0.37, 95% CI 0.19-0.69).
                Amnioinfusion improves the neonatal outcome and reduces the frequency of cesarian sections. Our purpose was to evaluate the efficacy of prophylactic amnioinfusion in decreasing neonatal morbidity associated with labor complicated by particulate meconium-stained amniotic fluid and to assess potential complications of this procedure.
                One hundred five laboring pregnant women with particulate (moderate or thick) meconium by subjective clinical analysis were randomly assigned to receive amnioinfusion or to receive standard obstetric care without amnioinfusion. Patients with any antepartum complications, other than the presence of meconium, were excluded from the study. Statistical analyses consisted of the two-tailed and paired Student t tests, Pearson chi 2 test, and Wilcoxon nonparametric test. Significance was set at p < 0.05.
                The study included 47 patients in the study group and 58 patients in the control group. A significantly greater proportion of study patients demonstrated decreased meconium concentration between rupture of membranes and delivery (46 of 46 vs 15 of 58, p < 0.001). The relative dilution of meconium consistency by objective analysis was significantly different between the study group and the control group (77.1% decrease vs 9.3% increase, p < 0.001). The proportion of neonates with meconium below the vocal cords was reduced in the study group (two of 47 vs 36 of 58, p < 0.001). Umbilical artery pH was increased in the study group neonates (7.29 +/- 0.01 vs 7.25 +/- 0.009, p < 0.05). The rate of neonatal acidemia was reduced in the study group (4 of 45 vs 12 of 50, p < 0.05). The rate of meconium aspiration syndrome was reduced in the study group (1 of 47 vs 8 of 58, p < 0.05). Maternal and neonatal morbidity rates were similar.
                Prophylactic amnioinfusion should be considered a possible addition to the intrapartum management of patients with particulate meconium-stained amniotic fluid. It is uncertain whether amnioinfusion (infusion of saline into the amniotic cavity) in women who have thick meconium staining of the amniotic fluid reduces the risk of perinatal death, moderate or severe meconium aspiration syndrome, or both.
                We performed a multicenter trial in which 1998 pregnant women in labor at 36 or more weeks of gestation who had thick meconium staining of the amniotic fluid were stratified according to the presence or absence of variable decelerations in fetal heart rate and then randomly assigned to amnioinfusion or to standard care. The composite primary outcome measure was perinatal death, moderate or severe meconium aspiration syndrome, or both.
                Perinatal death, moderate or severe meconium aspiration syndrome, or both occurred in 44 infants (4.5 percent) of women in the amnioinfusion group and 35 infants (3.5 percent) of women in the control group (relative risk, 1.26; 95 percent confidence interval, 0.82 to 1.95). Five perinatal deaths occurred in the amnioinfusion group and five in the control group. The rate of cesarean delivery was 31.8 percent in the amnioinfusion group and 29.0 percent in the control group (relative risk, 1.10; 95 percent confidence interval, 0.96 to 1.25).
                For women in labor who have thick meconium staining of the amniotic fluid, amnioinfusion did not reduce the risk of moderate or severe meconium aspiration syndrome, perinatal death, or other major maternal or neonatal disorders.
                Copyright 2005 Massachusetts Medical Society. We hypothesized that prophylactic intrapartum amnioinfusion in pregnancies complicated by thick meconium will not decrease the incidence of fetal distress, cesarean section for fetal distress, or meconium below the cords.
                Patients with thick meconium were randomized to amnioinfusion (n = 65) or control (n = 59). The amnioinfusion group received an 800 ml bolus of normal saline solution followed by a continuous infusion at 180 ml/hr. Continuous variables were compared by Student t test, and discrete variables were compared by chi 2 analysis and Fisher's exact test as appropriate.
                The incidence of fetal distress (16 of 65 vs 8 of 59) and cesarean section for fetal distress (seven of 65 vs seven of 59) was not significantly different between the amnioinfusion and control groups, respectively. The rate of meconium below the cords (one of 65 vs eight of 59) was significantly lower in patients receiving amnioinfusion (relative risk 0.09, confidence interval 0.01 and 0.82, p = 0.02). Two cases of meconium aspiration syndrome occurred in control patients but in none receiving amnioinfusion (p = 0.22).
                Prophylactic amnioinfusion in patients with thick meconium decreases the incidence of meconium below the cords and may subsequently have an impact on the incidence of meconium aspiration syndrome in larger series. Intrapartum amnioinfusion (AI) has been reported to decrease perinatal mortality and morbidity in women with meconium-stained liquor. Such work has not previously been performed at King Edward VIII Hospital (KEH), in a developing country, where the incidence of meconium-stained liquor is said to be extremely high.
                To establish whether AI during the intrapartum period for meconium-stained liquor decreases Caesarean section rates for fetal distress and decreases perinatal morbidity.
                Informed consent was obtained from patients in labour who were 3-8 cm dilated, with meconium-staining of the liquor, grades I to III inclusive, and who had a normal cardiotocograph on presentation at term. Sixty patients were included in the trial; 30 had AI. The control group was managed by standard methods. The study group had an amnioinfusion of 0.9% normal saline at 15 ml/min under continuous cardiotocographic monitoring, until a volume of 11 was completed. This was repeated if delivery did not occur within 4 h.
                The mean pH of umbilical arterial blood was significantly higher in the AI group (7.30 versus 7.23; P = 0.0029). In addition fewer patients in this group developed hypoxic ischaemic encephalopathy (0 versus 2 controls) or meconium aspiration syndrome (1 versus 4 controls). This was not statistically significant. Caesarean section for fetal distress was performed on fewer patients in the AI group (3 versus 7 controls), although this was not statistically significant.
                These results demonstrate that amnioinfusion is an effective technique for improving the perinatal outcome of pregnancies complicated by meconium-stained liquor in labour. The decrease in Caesarean sections for fetal distress, though not statistically significant in this study, has clinical relevance. Furthermore, this study suggests that amnioinfusion is cost effective in a busy, high-risk labour ward unit and consequently should become standard practice in the management of meconium-stained liquor in labour. The purpose of this prospective and randomized study is to evaluate the safety and efficacy of prophylactic transcervical amnioinfusion in the management of labor complicated by meconium. A preexisting intrauterine pressure catheter was used for amnioinfusion. The incidence of thick meconium was significantly lower after amnioinfusion, compared with standard management (5% versus 62% p less than 0.0005). This was also demonstrated with spectrophotometry. Significant differences between the amnioinfusion group and the control group were found for the following: arterial cord pH less than 7.20 (16% versus 38%, p less than 0.05); meconium more than trace below the vocal cords at delivery (0% versus 29%, p less than 0.05) and need for positive pressure ventilation at birth (16% versus 48%, p less than 0.05). No complications related to amnioinfusion were observed. We conclude that (1) transcervical amnioinfusion during labor complicated by meconium is a simple and apparently safe procedure, and that (2) amnioinfusion effectively decreases the frequency of thick meconium, the frequency of neonatal acidemia, the frequency of more than trace meconium below the vocal cords, and the need for positive pressure ventilation. Previous studies have demonstrated reduced perinatal morbidity in patients receiving amnioinfusion for meconium-stained amniotic fluid compared with control patients receiving no amnioinfusion. Because amnioinfusion for variable fetal heart rate decelerations has become accepted care, we sought to determine the benefit of prophylactic amnioinfusion for meconium compared with standard care, incorporating therapeutic amnioinfusion for variable decelerations.
                Ninety-three term patients with moderate to heavy meconium and no variable fetal heart rate decelerations were randomized to immediate prophylactic amnioinfusion (600 ml saline solution bolus followed by 3 ml/min) or to standard care (including therapeutic amnioinfusion for variable decelerations developing later). All babies had DeLee suctioning on delivery of the head. Laryngeal cords were visualized and tracheal suctioning performed when meconium was seen below the cords. Statistical comparisons were performed using Student t test, Fisher's exact test, or chi 2 analysis.
                There were no significant differences in the incidence of operative delivery, fetal distress, or meconium below the cords or in newborn Apgar scores and umbilical artery gas values between the amnioinfusion (n = 43) and control (n = 50) patients. There were four cases of meconium aspiration, three in the amnioinfusion group, one in the standard care group. The rate of endometritis-chorioamnionitis was higher (p = 0.3) in the amnioinfusion (16%) than in the control group (8%), although time from ruptured membranes to delivery (8.5 hours vs 7.3 hours) and duration of intrauterine monitoring (6.1 hours vs 5.3 hours) were not different.
                Although amnioinfusion does dilute amniotic meconium, prophylactic amnioinfusion for meconium in the absence of variable decelerations remains controversial. Prophylactic amnioinfusion in term pregnancies did not improve perinatal outcome and increased the risk for chorioamnionitis-endometritis. Together with recent reports, the current data suggest that the benefit of amnioinfusion for meconium-stained amniotic fluid is a result of the alleviation of variable fetal heart rate decelerations rather than meconium dilution. The null hypothesis is that the use of intrapartum amnioinfusion in labors complicated by the presence of thick meconium and oligohydramnios will not decrease the incidence of fetal distress, cesarean delivery, meconium aspiration, or meconium aspiration syndrome.
                One hundred seventy term and postterm patients with thick meconium and oligohydramnios were randomly chosen to receive amnioinfusion or standard obstetric care without amnioinfusion. The frequency of fetal distress, cesarean section, meconium aspiration, and meconium aspiration syndrome were subject to chi 2 analysis, Student's t test, or Fisher's exact test.
                The rate of fetal distress was significantly reduced in the amnioinfusion group compared with controls (three of 85 vs 19 of 85, relative risk 0.15, 95% confidence interval 0.06 to 0.42). The rate of cesarean section for fetal distress was significantly reduced in the amnioinfusion group (two of 85 vs 17 of 85, relative risk 0.118, confidence interval 0.03 to 0.49). The rates of meconium aspiration (four of 85 vs 33 of 85, relative risk 0.12, confidence interval 0.0449 to 0.327) and meconium aspiration syndrome (0 of 85 vs five of 85, relative risk 0.09, confidence interval 0.009 to 0.872) were significantly reduced by amnioinfusion.
                Amnioinfusion improves the outcome in pregnancies complicated by thick meconium and oligohydramnios. There are conflicting reports regarding the results of amnioinfusion in the management of meconium passage in utero. This study was done to evaluate transcervical amnioinfusion for meconium stained amniotic fluid during labour.
                196 women at term in early labour with meconium were randomized to receive either transcervical intrapartum amnioinfusion with saline (96) or routine obstetrical care (100). Transcervical amnioinfusion of one liter saline infused over 30-45 minutes. End points were relief of decelerations, incidence of vaginal delivery, presence of meconium below the neonatal cords, and X-ray evidence of meconium aspiration.
                Amnioinfusion resulted in relief of decelerations in 75% of cases as compared to 7% in the control group. Eighty-eight percent of patients delivered vaginally as compared to 58% in the control group (p< 0.001). Neonatal outcome was significantly better in the infusion group. The incidence of meconium below the vocal cords was reduced from 48% to 17% (p< 0.004) using amnioinfusion with positive X-rays for meconium aspiration in only 12.5% versus 26% (p < 0.5).
                We concluded that transcervical intrapartum amnioinfusion is a safe, simple and inexpensive technique that reduces operative intervention and improves neonatal outcome, and is of tremendous relevance in developing countries.
Amnioinfusion is associated with substantive improvements in perinatal outcome only in settings where facilities for perinatal surveillance are limited. It is not clear whether the benefits are due to dilution of meconium or relief of oligohydramnios.
In settings with standard peripartum surveillance, some non-substantive outcomes were improved in the initial analysis, but sensitivity analysis excluding trials with greater risk of bias eliminated these differences. Amnioinfusion is either ineffective in this setting, or its effects are masked by other strategies to optimise neonatal outcome.
The trials reviewed are too small to address the possibility of rare but serious maternal adverse effects of amnioinfusion.