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Study protocol of S...
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
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- Elden, Helen, 1959 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för vårdvetenskap och hälsa,Institute of Health and Care Sciences,Gothenburg Univ, Sahlgrenska Acad, Inst Hlth & Caring Sci, S-40530 Gothenburg, Sweden.
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- Hagberg, Henrik, 1955 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi,Institute of Clinical Sciences, Department of Obstetrics and Gynecology,Gothenburg Univ, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Perinatal Ctr,Dept Obstet & Gynecol,Inst Clin Sci, S-41685 Gothenburg, Sweden.
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- Wessberg, Anna, 1963 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för vårdvetenskap och hälsa,Institute of Health and Care Sciences,Gothenburg Univ, Sahlgrenska Acad, Inst Hlth & Caring Sci, S-40530 Gothenburg, Sweden.
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- Sengpiel, Verena, 1977 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi,Institute of Clinical Sciences, Department of Obstetrics and Gynecology,Gothenburg Univ, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Perinatal Ctr,Dept Obstet & Gynecol,Inst Clin Sci, S-41685 Gothenburg, Sweden.
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- Herbst, A. (författare)
- Skane Univ Hosp, S-21428 Malmo, Sweden.
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- Bullarbo, Maria, 1958 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi,Institute of Clinical Sciences, Department of Obstetrics and Gynecology,Gothenburg Univ, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Perinatal Ctr,Dept Obstet & Gynecol,Inst Clin Sci, S-41685 Gothenburg, Sweden.
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- Bergh, Christina, 1953 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi,Institute of Clinical Sciences, Department of Obstetrics and Gynecology,Gothenburg Univ, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Dept Obstet & Gynecol,Inst Clin Sci,Reprod Med, S-41685 Gothenburg, Sweden.
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- Bolin, Kristian (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för nationalekonomi med statistik,Department of Economics,Gothenburg Univ, Sch Business Econ & Law, Dept Econ & Stat, POB 640, S-40530 Gothenburg, Sweden.
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- Malbasic, S. (författare)
- South Alvsborg Cty Hosp, Dept Obstet & Gynecol, S-50182 Boras, Sweden.
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- Saltvedt, S. (författare)
- Karolinska Institutet,Karolinska Univ Hosp, Dept Obstet & Gynecol, S-17176 Stockholm, Sweden.
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- Stephansson, O. (författare)
- Karolinska Institutet,Karolinska Inst, Dept Med, Clin Epidemiol Unit, S-17176 Stockholm, Sweden.;Karolinska Univ Hosp, Dept Womens & Childrens Hlth, Div Obstet & Gynecol, S-17176 Stockholm, Sweden.
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- Wikström, Anna-Karin (författare)
- Uppsala universitet,Karolinska Institutet,Obstetrik & gynekologi
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- Ladfors, Lars, 1951 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi,Institute of Clinical Sciences, Department of Obstetrics and Gynecology,Gothenburg Univ, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Perinatal Ctr,Dept Obstet & Gynecol,Inst Clin Sci, S-41685 Gothenburg, Sweden.
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- Wennerholm, Ulla-Britt, 1948 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi,Institute of Clinical Sciences, Department of Obstetrics and Gynecology,Gothenburg Univ, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Perinatal Ctr,Dept Obstet & Gynecol,Inst Clin Sci, S-41685 Gothenburg, Sweden.;Karolinska Univ Hosp, Dept Obstet & Gynecol, S-17176 Stockholm, Sweden.
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(creator_code:org_t)
- 2016-03-07
- 2016
- Engelska.
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Ingår i: Bmc Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393. ; 16:49
- Relaterad länk:
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https://bmcpregnancy...
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https://uu.diva-port... (primary) (Raw object)
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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http://kipublication...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- 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/Design: 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. Discussion: 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reproduktionsmedicin och gynekologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Obstetrics, Gynaecology and Reproductive Medicine (hsv//eng)
Nyckelord
- Prolonged pregnancy
- Postterm
- Labour
- Induced
- Expectant management
- Perinatal outcome
- postterm pregnancy
- cesarean delivery
- prolonged pregnancy
- risk-factors
- newborn encephalopathy
- myocardial-infarction
- thrombus
- aspiration
- elective induction
- birth
- population
- Obstetrics & Gynecology
- Prolonged pregnancy
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Elden, Helen, 19 ...
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Hagberg, Henrik, ...
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Wessberg, Anna, ...
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Sengpiel, Verena ...
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Herbst, A.
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Bullarbo, Maria, ...
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visa fler...
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Bergh, Christina ...
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Bolin, Kristian
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Malbasic, S.
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Saltvedt, S.
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Stephansson, O.
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Wikström, Anna-K ...
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Ladfors, Lars, 1 ...
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Wennerholm, Ulla ...
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visa färre...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Reproduktionsmed ...
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Bmc Pregnancy an ...
- Av lärosätet
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Göteborgs universitet
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Karolinska Institutet
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Uppsala universitet