Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy
1 other identifier
interventional
508
1 country
1
Brief Summary
Post term pregnancy is a risk pregnancy. Aim of the study was to investigate whether induction of labor at gestational age 289(41 weeks+2 days) reduces neonatal morbidity compared to expectant management. Secondary aims was to assess the effect on mode of delivery and maternal complications, as well as assess women's views and experiences. Our 0-hypothesis was that induction of labor at gestational age 41+2 did not result in better outcome of pregnancy, measured as perinatal morbidity. Following inclusion, women were randomly allocated to induction of labor or to monitoring of pregnancy every third day until delivery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2002
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 6, 2006
CompletedFirst Posted
Study publicly available on registry
October 9, 2006
CompletedNovember 4, 2011
November 1, 2011
1.2 years
October 6, 2006
November 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neonatal morbidity
peri- en postnatal
Secondary Outcomes (5)
Maternal complications
peri- and postnatal
Mode of delivery
at birth
women's view
postpartum
Women's experiences
perinatal
Hormone levels
perinatal
Study Arms (2)
Induction
EXPERIMENTALinduction of labor at gestational age 289(41 weeks+2 days)
expectant management
NO INTERVENTIONexpectant management at gestational age 289(41 weeks+2 days)
Interventions
Eligibility Criteria
You may qualify if:
- Routine ultrasound scan and delivery at St.Olav's Hospital
- Ability to speak Norwegian
- Singleton pregnancy
- Gestational age 289 +/- 2 days
- Cephalic presentation
You may not qualify if:
- \- prelabor rupture of membranes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Olavs Hospitallead
- Norwegian University of Science and Technologycollaborator
Study Sites (1)
Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital
Trondheim, 7006, Norway
Related Publications (2)
Heimstad R, Skogvoll E, Mattsson LA, Johansen OJ, Eik-Nes SH, Salvesen KA. Induction of labor or serial antenatal fetal monitoring in postterm pregnancy: a randomized controlled trial. Obstet Gynecol. 2007 Mar;109(3):609-17. doi: 10.1097/01.AOG.0000255665.77009.94.
PMID: 17329511RESULTMiddleton P, Shepherd E, Morris J, Crowther CA, Gomersall JC. Induction of labour at or beyond 37 weeks' gestation. Cochrane Database Syst Rev. 2020 Jul 15;7(7):CD004945. doi: 10.1002/14651858.CD004945.pub5.
PMID: 32666584DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Runa Heimstad, MD
Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2006
First Posted
October 9, 2006
Study Start
September 1, 2002
Primary Completion
December 1, 2003
Study Completion
July 1, 2004
Last Updated
November 4, 2011
Record last verified: 2011-11