The Collaborative Randomised Amnioinfusion for Meconium Project (CRAMP): 1. South Africa

Abstract

Objective To evaluate transcervical amnioinfusion for meconium stained amniotic fluid during labout.Design Multicentre randomised controlled trial.Setting Four urban academic hospitals in South Africa. Obstetric surveillance included the use of Participants Women in labour at term with moderate or thick meconium staining of the amniotic fluid.Interventions 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.electronic fetal heart rate monitoring in most cases.Main outcome measures Caesarean section, meconium aspiration syndrome and perinatal mortality.Results Caesarean section rates were similar (amnioinfusion group 701 167 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.Conclusions 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.

Randomised trial of amnioinfusion during labour with meconium stained amniotic fluid

“…In our study the incidence of caesarean section in the amnioinfusion group was significantly lower than the control group (RR 0.47; 95% CI 0.24 -0.93). Similar results are reported by Khosla et al 15 This is in contrast to the findings reported by Hofmeyr 4 and Mahomed et al 10 : in the set ups with standard peripartum surveillance, Hofmeyr 4 reported that amnioinfusion reduced caesarean section rates in contrast to no difference reported by Hofmeyr et al 9 , Cialone et al 16 , and Sadovsky et al 17 Higher caesarean section rates with amnioinfusion were reported by Roger et al 18 The incidence of caesarean section for fetal distress was lower in the amnioinfusion group in the present study (RR 0.39; 95% CI 0.17 -0.87). Similar findings are reported by Lo and Rooers 19 , Moodley et al 20 and Macri et al 21 No effect on caesarean section for fetal distress was reported by Eriksen et al 22 or Spong et al 23 The probable explanation of the decrease of caesarean section on fetal distress in the amnioinfusion group is that amnioinfusion increases the volume of fluid around the fetus, therefore decreasing the theoretic probability of fetal distress related to cord compression.…”

Intrapartum amnioinfusion for meconium‐stained amniotic fluid: a systematic review of randomised controlled trials

“…15,27,31 Twelve studies were finally included in the main meta-analysis. One was an international trial coordinated in Canada, 16 six were conducted in the USA, 28,29,32,[35][36][37] one was in Spain, 17 two were in South Africa, 30,34 one was in India, 18 and one in Zimbabwe. 33 Studies included a total of 4030 women, 1999 allocated to AI and 2031 allocated to control.…”

“…The keywords used for the search were 'amnioinfusion' and 'meconium'. The searches were conducted for studies published between January 1980 and May 30,2005. We also manually screened the references of studies and review articles for relevant citations.…”

“…Yes (1) Yes (1) No (1) Yes (1) 4 Hofmeyr et al 30 South Africa Moderate or thick MSAF Normal saline 800 ml at 15 ml per minute, then 3 ml per minute of maintenance infusion…”

“…Nine studies specified that the neonatologists evaluating the babies were blinded to treatment allocation or that the assessment of primary outcome was adjudicated by a team that was blinded to treatment allocation. 16,17,[28][29][30]32,33,35,37 Most trials used aggressive combined obstetric and paediatric suctioning at delivery as a standard co-intervention in both treatment groups. Heterogeneity was noted across studies with respect to the AI protocols, and the endpoints were evaluated.…”