title: Induction of labour versus expectant management for large-for-date fetuses: a randomised controlled trial.
abstract: BACKGROUND
  Macrosomic fetuses are at increased risk of shoulder dystocia. We aimed to compare induction of labour with expectant management for large-for-date fetuses for prevention of shoulder dystocia and other neonatal and maternal morbidity associated with macrosomia.
  
  
  METHODS
  We did this pragmatic, randomised controlled trial between Oct 1, 2002, and Jan 1, 2009, in 19 tertiary-care centres in France, Switzerland, and Belgium. Women with singleton fetuses whose estimated weight exceeded the 95th percentile, were randomly assigned (1:1), via computer-generated permuted-block randomisation (block size of four to eight) to receive induction of labour within 3 days between 37(+0) weeks and 38(+6) weeks of gestation, or expectant management. Randomisation was stratified by centre. Participants and caregivers were not masked to group assignment. Our primary outcome was a composite of clinically significant shoulder dystocia, fracture of the clavicle, brachial plexus injury, intracranial haemorrhage, or death. We did analyses by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00190320.
  
  
  RESULTS
  We randomly assigned 409 women to the induction group and 413 women to the expectant management group, of whom 407 women and 411 women, respectively, were included in the final analysis. Mean birthweight was 3831 g (SD 324) in the induction group and 4118 g (392) in the expectant group. Induction of labour significantly reduced the risk of shoulder dystocia or associated morbidity (n=8) compared with expectant management (n=25; relative risk [RR] 0·32, 95% CI 0·15-0·71; p=0·004). We recorded no brachial plexus injuries, intracranial haemorrhages, or perinatal deaths. The likelihood of spontaneous vaginal delivery was higher in women in the induction group than in those in the expectant management group (RR 1·14, 95% CI 1·01-1·29). Caesarean delivery and neonatal morbidity did not differ significantly between the groups.
  
  
  CONCLUSIONS
  Induction of labour for suspected large-for-date fetuses is associated with a reduced risk of shoulder dystocia and associated morbidity compared with expectant management. Induction of labour does not increase the risk of caesarean delivery and improves the likelihood of spontaneous vaginal delivery. These benefits should be balanced with the effects of early-term induction of labour.
  
  
  BACKGROUND
  Assistance Publique-Hôpitaux de Paris and the University of Geneva.
authors: Département de Gynécologie et d'Obstétrique, Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva, Switzerland. Electronic address: michel.boulvain@hcuge.ch.
authors: Michel
authors: M
authors: Boulvain
authors: Département de Gynécologie-Obstétrique, APHP, Hôpital Bicêtre, Hôpital Antoine Béclère, Université Paris Sud, Faculté de Medecine, Orsay, Paris, France.
authors: Marie-Victoire
authors: MV
authors: Senat
authors: Pôle de Gynécologie-Obstétrique, Hôpital Bretonneau, CHRU Tours, Tours, France.
authors: Franck
authors: F
authors: Perrotin
authors: Département de Gynécologie-Obstétrique, Hôpital Mère-Enfant, Nantes, France.
authors: Norbert
authors: N
authors: Winer
authors: Département de Gynécologie-Obstétrique et Médecine de la Reproduction, CHU de Caen, Caen, France.
authors: Gael
authors: G
authors: Beucher
authors: Département de Gynécologie-Obstétrique, Hôpital Jeanne de Flandre, Lille, France.
authors: Damien
authors: D
authors: Subtil
authors: Département de Gynécologie-Obstétrique, Hôpital Nord, Marseille, France.
authors: Florence
authors: F
authors: Bretelle
authors: Département de Gynécologie-Obstétrique, Hôpital Bichat, AP-HP, Paris, France.
authors: Elie
authors: E
authors: Azria
authors: Département de Gynécologie-Obstétrique, Centre Hospitalier Régional, Annecy, France.
authors: Dominique
authors: D
authors: Hejaiej
authors: Pôle de Gynécologie-Obstétrique et Reproduction Humaine, CHU de Clermont-Ferrand, Hôpital Estaing, Clermont-Ferrand, France.
authors: Françoise
authors: F
authors: Vendittelli
authors: Département de Gynécologie-Obstétrique, Hôpital de La Conception, Marseille, France.
authors: Marianne
authors: M
authors: Capelle
authors: Département de Gynécologie-Obstétrique, Hôpital Hautepierre, Strasbourg, France.
authors: Bruno
authors: B
authors: Langer
authors: Groupe Hospitalier de l'Institut Catholique de Lille, Lille, France.
authors: Richard
authors: R
authors: Matis
authors: Département de Gynécologie-Obstétrique, Hôpital Paul de Viguier, Toulouse, France.
authors: Laure
authors: L
authors: Connan
authors: Pôle de Gynécologie-Obstétrique, Hôpital Hôtel Dieu, Angers, France.
authors: Philippe
authors: P
authors: Gillard
authors: Département de Gynécologie-Obstétrique, Hôpital Erasme, Bruxelles, Belgium.
authors: Christine
authors: C
authors: Kirkpatrick
authors: Département de Gynécologie-Obstétrique, Hôpital Erasme, Bruxelles, Belgium; Département de Gynécologie-Obstétrique, Hôpital Ambroise Paré, Mons, Belgium.
authors: Gilles
authors: G
authors: Ceysens
authors: Département de Gynécologie-Obstétrique, Hôpital Brugmann, Bruxelles, Belgium.
authors: Gilles
authors: G
authors: Faron
authors: Département de Gynécologie et d'Obstétrique, Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva, Switzerland.
authors: Olivier
authors: O
authors: Irion
authors: Département de Gynécologie-Obstétrique, Hôpital Poissy Saint-Germain, Université Versailles- St Quentin, France.
authors: Patrick
authors: P
authors: Rozenberg
mesh_terms: D000328:Adult; D001530:Belgium; D002585:Cesarean Section / Q000706:statistics & numerical data; D036861:Delivery, Obstetric / Q000706:statistics & numerical data*; D004420:Dystocia / Q000453:epidemiology / Q000517:prevention & control; D005260:Female; D005320:Fetal Macrosomia / Q000453:epidemiology*; D005602:France; D006801:Humans; D015994:Incidence; D007751:Labor, Induced / Q000706:statistics & numerical data*; D007744:Obstetric Labor Complications / Q000453:epidemiology / Q000517:prevention & control; D010043:Outcome and Process Assessment, Health Care / Q000706:statistics & numerical data*; D011247:Pregnancy; D013557:Switzerland; D062606:Tertiary Care Centers / Q000706:statistics & numerical data