search
Back to results

Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

Primary Purpose

Perinatal Morbidity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
induction of labor
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perinatal Morbidity focused on measuring Asphyxia neonatorum, Birth Injury, Meconium Aspiration Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Female

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Induction

expectant management

Arm Description

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

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

Outcomes

Primary Outcome Measures

Neonatal morbidity

Secondary Outcome Measures

Maternal complications
Mode of delivery
women's view
Women's experiences
Hormone levels

Full Information

First Posted
October 6, 2006
Last Updated
November 3, 2011
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT00385229
Brief Title
Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy
Official Title
Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Morbidity
Keywords
Asphyxia neonatorum, Birth Injury, Meconium Aspiration Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
508 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induction
Arm Type
Experimental
Arm Description
induction of labor at gestational age 289(41 weeks+2 days)
Arm Title
expectant management
Arm Type
No Intervention
Arm Description
expectant management at gestational age 289(41 weeks+2 days)
Intervention Type
Drug
Intervention Name(s)
induction of labor
Intervention Description
Misoprostol, Dinoprostone, amniotomy, Oxytocin
Primary Outcome Measure Information:
Title
Neonatal morbidity
Time Frame
peri- en postnatal
Secondary Outcome Measure Information:
Title
Maternal complications
Time Frame
peri- and postnatal
Title
Mode of delivery
Time Frame
at birth
Title
women's view
Time Frame
postpartum
Title
Women's experiences
Time Frame
perinatal
Title
Hormone levels
Time Frame
perinatal

10. Eligibility

Sex
Female
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Runa Heimstad, MD
Organizational Affiliation
Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
17329511
Citation
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.
Results Reference
result
PubMed Identifier
32666584
Citation
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.
Results Reference
derived

Learn more about this trial

Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

We'll reach out to this number within 24 hrs