Objective To assess whether oxytocin administered before clamping the umbilical cord modifies the volume of placental transfusion.
Design Randomised controlled trial.
Methods Mothers of term infants born vigorous by vaginal delivery with informed consent provided in early labour were randomly assigned to oxytocin (10 IU) given intravenously within 15 s of birth (group 1) or after clamping the umbilical cord 3 min after delivery (group 2). Soon after birth, all infants were weighed using a 1 g precision scale and subsequently placed on the mother’s abdomen or chest. At 3 min, in both groups, the cord was clamped and cut, and the weight was again obtained. The primary outcome (volume of placental transfusion) was estimated by the difference in weights.
Results 144 patients were included. There were no differences in the primary outcome: infants in group 1 (n=70) gained a mean weight of 85.9 g (SD 48.3), and in group 2 (n=74) 86.7 g (SD 49.6) (p=0.92). No differences were found in secondary outcomes, including newborns’ haematocrit and bilirubin concentrations and severe maternal postpartum haemorrhage. On the advice of the Data and Safety Monitoring Committee, the trial was stopped due to futility at 25% of the planned sample size.
Conclusions When umbilical cord clamping is delayed for 3 min, term newborn infants born vigorous receive a clinically significant placental transfusion which is not modified by the administration of intravenous oxytocin immediately after birth.
Trial registration number NCT02618499.
- delivery room
- placental transfusion
- umbilical cord clamping
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Contributors NV was responsible for the idea of the study, developed the protocol, organised the study methods, managed and coordinated the study, participated in data analysis, and wrote the report. DSS developed the protocol, managed and coordinated the study, trained the staﬀ, participated in data analysis, reviewed the study methods and data collection procedures, and wrote the report. GC developed the protocol and reviewed the report. LMP developed the protocol and wrote the report. ALF participated in the development of the protocol, designed the statistical methodology, and performed the data analysis and statistical evaluation. JEG and NPR participated in data management and analysis of the results, and reviewed the report. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Funding Perez Companc Foundation and Foundation for Maternal-Infant Health (Fundasamin) funded the study. The sponsor of the study had no role in study design, data collection, data analysis, data interpretation and writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
Competing interests None declared.
Ethics approval Protocol and consent were approved by the hospital’s institutional review board.
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.