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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
  Purpose

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


Condition Intervention
Perinatal Morbidity
 Drug: induction of labor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Neonatal morbidity [ Time Frame: peri- en postnatal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 508
Study Start Date: September 2002
Study Completion Date: July 2004
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induction
induction of labor at gestational age 289(41 weeks+2 days)
 Drug: induction of labor
Misoprostol, Dinoprostone, amniotomy, Oxytocin
No Intervention: expectant management
expectant management at gestational age 289(41 weeks+2 days)

  Eligibility

Genders Eligible for Study:   Female
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385229

Locations
Norway
Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
Study Director: Runa Heimstad, MD Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital
  More Information

Publications:

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00385229     History of Changes
Other Study ID Numbers: REK 106-01
Study First Received: October 6, 2006
Last Updated: November 3, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by St. Olavs Hospital:
Asphyxia neonatorum
Birth Injury
Meconium Aspiration Syndrome

Additional relevant MeSH terms:
Pregnancy, Prolonged
Pregnancy Complications

ClinicalTrials.gov processed this record on May 19, 2013