The Collaborative Randomised Amnioinfusion for Meconium Project (CRAMP): 2. Zimbabwe.

OBJECTIVE: To evaluate transcervical amnioinfusion for meconium stained amniotic fluid during labour. DESIGN: Multicentre randomised controlled trial. SETTING: A large urban academic hospital. Electronic fetal heart rate monitoring was not used. PARTICIPANTS: Women in labour at term with moderate or thick meconium staining of the amniotic fluid. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: Caesarean section, meconium aspiration syndrome and perinatal mortality. RESULTS: 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). CONCLUSIONS: 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.

PIP: The presence of meconium in the amniotic fluid is associated with increased perinatal morbidity and mortality. Saline amnioinfusion during labor has been shown, in several clinical trials, to reduce the incidence of cesarean section and meconium aspiration syndrome. A randomized controlled trial conducted at Harare Maternity Hospital in Zimbabwe sought to confirm the benefits of amnioinfusion for meconium-stained amniotic fluid during labor for perinatal outcome. In the intervention group (n = 325), 500 ml of saline was transcervically amnioinfused over a 30-minute period, followed by 500 ml at 30 drops per minute for the duration of labor. The control group (n = 336) received routine obstetric care. The cesarean section rate was 9.5% in the intervention group and 12.3% in the control group (relative risk (RR), 0.84; 95% confidence interval (CI), 0.53-1.32). Meconium aspiration syndrome was significantly less frequent in the amnioinfusion group (3.1%) than the control group (12.8%) (RR, 0.24; 95% CI, 0.12-0.48). The perinatal death rate was 1.2% in the amnioinfusion group and 3.6% among controls (RR, 0.34; 95% CI, 0.11-1.06). Also recorded in the amnioinfusion group were significant reductions in the following perinatal morbidity measures: 5-minute Apgar score below 7, neonatal intensive care admissions, neonatal ventilation, and hypoxic ischemic encephalopathy. The striking improvements in perinatal outcome recorded among women in the amnioinfusion group suggest the feasibility of more widespread use of this simple procedure in developing country settings without routine electronic fetal monitoring facilities.

Randomised controlled trial of intrapartum fetal heart rate monitoring.

OBJECTIVE: To compare effectiveness of different methods of monitoring intrapartum fetal heart rate. DESIGN: Prospective randomised controlled trial. SETTING: Referral maternity hospital, Harare, Zimbabwe. SUBJECTS: 1255 women who were 37 weeks or more pregnant with singleton cephalic presentation and normal fetal heart rate before entry into study. INTERVENTIONS: Intermittent monitoring of fetal heart rate by electronic monitoring, Doppler ultrasound, use of Pinard stethoscope by a research midwife, or routine use of Pinard stethoscope by attending midwife. MAIN OUTCOME MEASURES: Abnormal fetal heart rate patterns, need for operative delivery for fetal distress, neonatal mortality, Apgar scores, admission to neonatal unit, neonatal seizures, and hypoxic ischaemic encephalopathy. RESULTS: Abnormalities in fetal heart rate were detected in 54% (172/318) of the electronic monitoring group, 32% (100/312) of the ultrasonography group, 15% (47/310) of the Pinard stethoscope group, and 9% (28/315) of the routine monitoring group. Caesarean sections were performed for 28% (89%), 24% (76), 10% (32), and 15% (46) of the four groups respectively. Neonatal outcome was best in the ultrasonography group: hypoxic ischaemic encephalopathy occurred in two, one, seven, and 10 cases in the four groups respectively; neonatal seizures occurred only in the last two groups (six and nine cases respectively); and deaths occurred in eight, two, five, and nine cases respectively. CONCLUSIONS: Abnormalities in fetal heart rate were more reliably detected by Doppler ultrasonography than with Pinard stethoscope, and its use resulted in good perinatal outcome. The use of relatively cheap ultrasound monitors should be further evaluated and promoted in obstetric units caring for high risk pregnancies in developing countries with scarce resources.