Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

NCT ID: NCT00385229

Last Updated: 2011-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

508 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2004-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Perinatal Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Induction

induction of labor at gestational age 289(41 weeks+2 days)

Group Type EXPERIMENTAL

induction of labor

Intervention Type DRUG

Misoprostol, Dinoprostone, amniotomy, Oxytocin

expectant management

expectant management at gestational age 289(41 weeks+2 days)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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induction of labor

Misoprostol, Dinoprostone, amniotomy, Oxytocin

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Runa Heimstad, MD

Role: STUDY_DIRECTOR

Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital

Locations

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Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 17329511 (View on PubMed)

Middleton 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.

Reference Type DERIVED
PMID: 32666584 (View on PubMed)

Other Identifiers

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REK 106-01

Identifier Type: -

Identifier Source: org_study_id