title: Study protocol of SWEPIS a Swedish multicentre register based randomised controlled trial to compare induction of labour at 41 completed gestational weeks versus expectant management and induction at 42 completed gestational weeks.
abstract: BACKGROUND
  Observational data shows that postterm pregnancy (≥42 gestational weeks, GW) and late term pregnancy (≥41 GW), as compared to term pregnancy, is associated with an increased risk for adverse outcome for the mother and infant. Standard care in many countries is induction of labour at 42 GW. There is insufficient scientific support that induction of labour at 41 GW, as compared with expectant management and induction at 42 GW will reduce perinatal mortality and morbidity without an increase in operative deliveries, negative delivery experiences or higher costs. Large randomised studies are needed since important outcomes; such as perinatal mortality and hypoxic ischaemic encephalopathy are rare events.
  
  
  METHODS
  A total of 10 038 healthy women ≥18 years old with a normal live singleton pregnancy in cephalic presentation at 41 GW estimated with a first or second trimester ultrasound, who is able to understand oral and written information will be randomised to labour induction at 41 GW (early induction) or expectant management and induction at 42 GW (late induction). Women will be recruited at university clinics and county hospitals in Sweden comprising more than 65 000 deliveries per year. Primary outcome will be a composite of stillbirth, neonatal mortality and severe neonatal morbidity. Secondary outcomes will be other adverse neonatal and maternal outcomes, mode of delivery, women's experience, cost effectiveness and infant morbidity up to 3 months of age. Data on background variables, obstetric and neonatal outcomes will be obtained from the Swedish Pregnancy Register and the Swedish Neonatal Quality Register. Data on women's experiences will be collected by questionnaires after randomisation and 3 months after delivery. Primary analysis will be intention to treat. The statistician will be blinded to group and intervention.
  
  
  CONCLUSIONS
  It is important to investigate if an intervention at 41 GW is superior to standard care in order to reduce death and lifelong disability for the children. The pregnant population, >41 GW, constitutes 15-20% of all pregnancies and the results of the study will thus have a great impact. The use of registries for randomisation and collection of outcome data represents a unique and new study design.
  
  
  BACKGROUND
  The study was registered in Current Controlled Trials, ISRCTN26113652 the 30(th) of March 2015 (DOI 10.1186/ISRCTN26113652 ).
authors.affiliation: Gothenburg University, Institute of Health and Caring Sciences, Sahlgrenska Academy, S-405 30, Gothenburg, Sweden. helen.elden@gu.se.
authors.forename: Helen
authors.initials: H
authors.lastname: Elden
authors.affiliation: Gothenburg University, Perinatal centre, Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, East, S-416 85, Gothenburg, Sweden.
authors.forename: Henrik
authors.initials: H
authors.lastname: Hagberg
authors.affiliation: Gothenburg University, Institute of Health and Caring Sciences, Sahlgrenska Academy, S-405 30, Gothenburg, Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Wessberg
authors.affiliation: Gothenburg University, Perinatal centre, Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, East, S-416 85, Gothenburg, Sweden.
authors.forename: Verena
authors.initials: V
authors.lastname: Sengpiel
authors.affiliation: Skane University Hospital, S-214 28, Malmo, Sweden.
authors.forename: Andreas
authors.initials: A
authors.lastname: Herbst
authors.affiliation: Gothenburg University, Perinatal centre, Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, East, S-416 85, Gothenburg, Sweden.
authors.forename: Maria
authors.initials: M
authors.lastname: Bullarbo
authors.affiliation: Gothenburg University, Reproductive Medicine, Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, S-416 85, Gothenburg, Sweden.
authors.forename: Christina
authors.initials: C
authors.lastname: Bergh
authors.affiliation: Gothenburg University, Department of Economics and Statistics, School Business, Economics and Law, P.O. Box 640, S-405 30, Gothenburg, Sweden.
authors.forename: Kristian
authors.initials: K
authors.lastname: Bolin
authors.affiliation: South Alvsborg County Hospital, Department of Obstetrics and Gynecology, S- 501 82, Boras, Sweden.
authors.forename: Snezana
authors.initials: S
authors.lastname: Malbasic
authors.affiliation: Department of Obstetrics and Gynecology, Karolinska University Hospital, 171 76, Stockholm, Sweden.
authors.forename: Sissel
authors.initials: S
authors.lastname: Saltvedt
authors.affiliation: Clinical Epidemiology Unit, Department of Medicine, Solna, Karolinska Institute, S-171 76, Stockholm, Sweden.|Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Solna, Karolinska University Hospital, S-171 76, Stockholm, Sweden.
authors.forename: Olof
authors.initials: O
authors.lastname: Stephansson
authors.affiliation: Uppsala University, Women's and Children's Health, Akademiska Hospital, SE-751 85, Uppsala, Sweden.
authors.forename: Anna-Karin
authors.initials: AK
authors.lastname: Wikström
authors.affiliation: Gothenburg University, Perinatal centre, Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, East, S-416 85, Gothenburg, Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Ladfors
authors.affiliation: Gothenburg University, Perinatal centre, Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, East, S-416 85, Gothenburg, Sweden.
authors.forename: Ulla-Britt
authors.initials: UB
authors.lastname: Wennerholm
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D036861:Delivery, Obstetric / Q000379:methods; D005260:Female; D005865:Gestational Age; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000209:etiology; D007751:Labor, Induced / Q000009:adverse effects / Q000379:methods*; D007743:Labor, Obstetric; D011247:Pregnancy; D011256:Pregnancy Outcome; D011273:Pregnancy, Prolonged; D012042:Registries; D050497:Stillbirth; D013548:Sweden; D047929:Term Birth; D055815:Young Adult