NCT04603859

Brief Summary

The rate of overweight and obese women becoming pregnant is increasing. Obesity in pregnancy along with delivery by cesarean section in obese women is associated with several complications as compared to normal weight women. The longer the woman is pregnant, the longer she is at risk. In an otherwise low-risk pregnant woman at term, it is an ongoing clinical dilemma, whether the benefits of elective induction of labor and termination of the pregnancy will outweigh the potential harms from concomitant induction and delivery process. The proposed study is a randomized controlled study of elective induction versus expectant management in obese women. The study will be carried out as a national multicenter study with inclusion of 1900 participants from Danish delivery wards. The null hypothesis is that the caesarean section rate is similar with elective induction of labor at 39 weeks of gestation, compared with expectant management among pregnant women with pre- or early pregnancy BMI≥30.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,900

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
0mo left

Started Oct 2020

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Oct 2020Jun 2026

First Submitted

Initial submission to the registry

October 12, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

October 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

5.6 years

First QC Date

October 12, 2020

Last Update Submit

July 2, 2024

Conditions

PregnancyObesityParturition

Keywords

Induction of laborExpectant managementCesarean section

Outcome Measures

Primary Outcomes (1)

  • Caesarean section

    number (no.)

    At delivery

Secondary Outcomes (24)

  • Mode of delivery if not by caesarean

    At delivery

  • Mode of delivery

    At delivery

  • Vaginal assisted delivery

    At delivery

  • Indication for caesarean section (more than one indication is possible)

    At delivery

  • Indication for vaginal assisted delivery (more than one is possible)

    At delivery

  • +19 more secondary outcomes

Other Outcomes (4)

  • Neonatal characteristics 1

    At delivery

  • Neonatal characteristics 2

    At delivery

  • Maternal experience on birth

    4-6 weeks postpartum

  • +1 more other outcomes

Study Arms (2)

Elective induction of labour

EXPERIMENTAL

Elective induction of labour at 39 gestational weeks and 0 to 3 days.

Procedure: Elective induction of labor at 39 gestational weeks and 0 to 3 days

Expectant management

NO INTERVENTION

Awaiting spontaneous labor.

Interventions

Elective induction of labor at 39 gestational weeks and 0 to 3 daysPROCEDURE

Elective induction of labor (eIOL) according to local policies

Also known as: eIOL
Elective induction of labour

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women with pre- or early pregnancy BMI ≥ 30 kg/m2

You may not qualify if:

  • Legal or ethical considerations: maternal age \<18 years, language difficulties requiring an interpreter or translator
  • Multiple pregnancy
  • Previous caesarean section
  • Uncertain gestational age, defined as gestational age determined by other measurements than the Crown-Rump length (CRL) Measurement
  • Planned elective caesarean section at time of randomisation
  • Fetal contraindications to IOL at time of randomisation: e.g. non-cephalic presentation, or other fetal conditions contraindicating vaginal delivery
  • Fetal contraindications to expectant management at time of randomisation
  • Maternal contraindications to IOL at time of randomisation: e.g. placenta previa/accreta, vasa previa
  • Maternal contraindications to expectant management at time of randomisation: e.g. maternal medical conditions, ultrasonically diagnosed oligohydramnios (DVP\< 2 cm), signs of labour including pre-labour rupture of membranes (PROM)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Rigshospitalet Juliane Marie Centre

Copenhagen, Denmark

RECRUITING

Herlev Hospital

Herlev, Denmark

RECRUITING

Gødstrup Regional Hospital

Herning, Denmark

RECRUITING

North Zealand's Hospital

Hillerød, Denmark

RECRUITING

Hvidovre Hospital

Hvidovre, Denmark

RECRUITING

Kolding Hospital

Kolding, Denmark

RECRUITING

Nykøbing Falster Hospital

Nykøbing Falster, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

Randers Regional Hospital

Randers, Denmark

RECRUITING

Zealand University Hospital

Roskilde, Denmark

RECRUITING

Viborg Hospital

Viborg, Denmark

RECRUITING

Related Publications (1)

  • Krogh LQ, Boie S, Henriksen TB, Thornton J, Fuglsang J, Glavind J. Induction of labour at 39 weeks versus expectant management in low-risk obese women: study protocol for a randomised controlled study. BMJ Open. 2022 Apr 25;12(4):e057688. doi: 10.1136/bmjopen-2021-057688.

    PMID: 35470194DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lise Q Krogh, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Julie Glavind, MD, PhD

    Aarhus University Hospital

    STUDY CHAIR

  • Sidsel Boie, MD, PhD

    Randers Regional Hospital

    STUDY CHAIR

  • Jens Fuglsang, MD, PhD

    Aarhus University Hospital

    STUDY CHAIR

  • Tine B Henriksen, MD, PhD

    Aarhus University Hospital

    STUDY CHAIR

  • Jim Thornton, MD, PhD

    Nottingham University

    STUDY CHAIR

  • Katja A Taastrøm, Midwife, MSc

    Aarhus University Hospital

    STUDY CHAIR

  • Anne Cathrine M Kjeldsen, Midwife, MSc

    Aarhus University Hospital

    STUDY CHAIR

Central Study Contacts

Lise Q Krogh, MD

CONTACT

0045 51242102lise.qvirin.krogh@clin.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 27, 2020

Study Start

October 19, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

The final dataset will be publicly available in an anonymised form using an open data repository (i.e. CERN) or another equivalent database. All relevant trial-related documents will be shared along with the data.

Time Frame
Beginning three months and ending three years after the publication of the last trial results.
Access Criteria
Data will be available for any research purpose to all interested parties who have approval from an independent review committee. Interested parties will be able to request the data by contacting the trial sponsor. Authorship of publications emerging from the shared data will follow standard authorship guidelines and will include authors from the WINDOW study group depending on the nature of their involvement.

Locations

DK(12)