Purpose: Our trial aimed to assess the effectiveness of amnioinfusion for a second attempt at external cephalic version (ECV).
Material and methods: This open randomized controlled trial was planned with a sequential design. Women at a term ≥36 weeks of gestation with a singleton fetus in breech presentation and a first unsuccessful ECV were recruited in two level-3 maternity units. They were randomly allocated to transabdominal amnioinfusion with a 500-mL saline solution under ultrasound surveillance or no amnioinfusion before the second ECV attempt. Trained senior obstetricians performed all procedures. The primary outcome was the cephalic presentation rate at delivery. Analyses were conducted according to intention to treat (NCT00465712).
Result: Recruitment difficulties led to stopping the trial after a 57-month period, 119 women were randomized: 59 allocated to amnioinfusion + ECV and 60 to ECV only. Data were analyzed without applying the sequential feature of the design. The rate of cephalic presentation at delivery did not differ significantly according to whether the second version attempt was or was not preceded by amnioinfusion (20 versus 12%, p = .20). Premature rupture of the membranes occurred for 15% of the women in the amnioinfusion group.
Conclusion: Amnioinfusion before a second attempt to external version does not significantly increase the rate of cephalic presentation at delivery.
Keywords: Breech presentation; amnioinfusion; cephalic presentation; external cephalic version; randomized trial.