Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

November 3, 2011 updated by: St. Olavs Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

508

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7006
        • Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neonatal morbidity
Time Frame: peri- en postnatal
peri- en postnatal

Secondary Outcome Measures

Outcome Measure
Time Frame
Maternal complications
Time Frame: peri- and postnatal
peri- and postnatal
Mode of delivery
Time Frame: at birth
at birth
women's view
Time Frame: postpartum
postpartum
Women's experiences
Time Frame: perinatal
perinatal
Hormone levels
Time Frame: perinatal
perinatal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

Investigators

  • Study Director: Runa Heimstad, MD, Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

October 6, 2006

First Submitted That Met QC Criteria

October 6, 2006

First Posted (Estimate)

October 9, 2006

Study Record Updates

Last Update Posted (Estimate)

November 4, 2011

Last Update Submitted That Met QC Criteria

November 3, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 106-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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