title: Amnioinfusion for women with a singleton breech presentation and a previous failed external cephalic version: a randomized controlled trial.
abstract: OBJECTIVE
  Our trial aimed to assess the effectiveness of amnioinfusion for a second attempt at external cephalic version (ECV).
  
  
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Amnioinfusion before a second attempt to external version does not significantly increase the rate of cephalic presentation at delivery.
authors.affiliation: a Department of Obstetrics, Gynecology and Fetal Medicine , University Hospital of Tours , Tours , France.|b Université François-Rabelais de Tours , Tours , France.
authors.forename: Caroline
authors.identifier: http://orcid.org/0000-0002-1176-0991
authors.initials: C
authors.lastname: Diguisto
authors.affiliation: c Department of Obstetrics, Gynecology and Fetal Medicine , University Hospital of Nantes , Nantes , France.
authors.forename: Norbert
authors.initials: N
authors.lastname: Winer
authors.affiliation: a Department of Obstetrics, Gynecology and Fetal Medicine , University Hospital of Tours , Tours , France.|d Department of Obstetrics, Gynecology , Centre Hospitalier Régional Orléans , Orléans , France.
authors.forename: Celine
authors.initials: C
authors.lastname: Descriaud
authors.affiliation: b Université François-Rabelais de Tours , Tours , France.|e INSERM CIC 1415 , Tours , France.
authors.forename: Elsa
authors.initials: E
authors.lastname: Tavernier
authors.affiliation: a Department of Obstetrics, Gynecology and Fetal Medicine , University Hospital of Tours , Tours , France.|b Université François-Rabelais de Tours , Tours , France.
authors.forename: Victoire
authors.initials: V
authors.lastname: Weymuller
authors.affiliation: b Université François-Rabelais de Tours , Tours , France.|e INSERM CIC 1415 , Tours , France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Giraudeau
authors.affiliation: a Department of Obstetrics, Gynecology and Fetal Medicine , University Hospital of Tours , Tours , France.|b Université François-Rabelais de Tours , Tours , France.
authors.forename: Franck
authors.initials: F
authors.lastname: Perrotin
mesh_terms: D000328:Adult; D001946:Breech Presentation / Q000628:therapy*; D036861:Delivery, Obstetric / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D011247:Pregnancy; D012965:Sodium Chloride / Q000008:administration & dosage*; D014710:Version, Fetal
chemical_list: D012965:Sodium Chloride
keywords: Breech presentation; amnioinfusion; cephalic presentation; external cephalic version; randomized trial