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Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00385229
First received: October 6, 2006
Last updated: November 3, 2011
Last verified: November 2011
History of Changes

October 6, 2006
November 3, 2011
September 2002
December 2003   (final data collection date for primary outcome measure)
Neonatal morbidity [ Time Frame: peri- en postnatal ] [ Designated as safety issue: No ]
Neonatal morbidity
Complete list of historical versions of study NCT00385229 on ClinicalTrials.gov Archive Site
  • Maternal complications [ Time Frame: peri- and postnatal ] [ Designated as safety issue: No ]
  • Mode of delivery [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • women's view [ Time Frame: postpartum ] [ Designated as safety issue: No ]
  • Women's experiences [ Time Frame: perinatal ] [ Designated as safety issue: No ]
  • Hormone levels [ Time Frame: perinatal ] [ Designated as safety issue: No ]
  • Maternal complications
  • Mode of delivery
  • women's view
  • Women's experiences
  • Hormones
Not Provided
Not Provided
 
Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy
Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Perinatal Morbidity
Drug: induction of labor
Misoprostol, Dinoprostone, amniotomy, Oxytocin
  • Experimental: Induction
    induction of labor at gestational age 289(41 weeks+2 days)
    Intervention: Drug: induction of labor
  • No Intervention: expectant management
    expectant management at gestational age 289(41 weeks+2 days)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
508
July 2004
December 2003   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Routine ultrasound scan and delivery at St.Olav's Hospital
  • Ability to speak Norwegian
  • Singleton pregnancy
  • Gestational age 289 +/- 2 days
  • Cephalic presentation

Exclusion criteria:

- prelabor rupture of membranes
Female
Not Provided
Not Provided
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00385229
REK 106-01
No
St. Olavs Hospital
St. Olavs Hospital
Norwegian University of Science and Technology
Study Director: Runa Heimstad, MD Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital
St. Olavs Hospital
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP