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CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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.
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.
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