Status:
TERMINATED
Comparing Outpatient and Inpatient Use of a Cervical Balloon for Starting Labor in Low-Risk Pregnancies.
Lead Sponsor:
Ziekenhuis Oost-Limburg
Collaborating Sponsors:
AZ Sint-Lucas Brugge
University Hospital, Antwerp
Conditions:
Induction of Labor
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Why was this study done? About 20-30% of pregnancies involve labor being started artificially, known as induction. One way to do this is with a balloon catheter placed in the cervix, which helps prepa...
Detailed Description
Study Design and Approval This was a randomised controlled trial - a scientific study designed to compare two groups as fairly as possible. It took place in four hospitals in Belgium: Ziekenhuis Oos...
Eligibility Criteria
Inclusion
- women \>18 years of age with singleton pregnancies, cephalic presentation and a unfavourable cervix requiring priming (Bishop Score ≤ 6) that needed an IOL for low risk indications: post-term, macrosomia, patient's preference (\> 38 0/7 weeks of gestational age).
Exclusion
- : multiple pregnancies, preterm premature rupture of membranes (pPROM), foetal growth restriction (FGR), placenta-accreta spectrum (PAS), previous C-Section(s), non-cephalic presentation, gestational diabetes, hypertensive disorders of pregnancy, living at \>60 minutes from the hospital, any other maternal or foetal morbidity, any other contraindication to vaginal birth.
Key Trial Info
Start Date :
August 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT06983535
Start Date
August 15 2016
End Date
February 1 2024
Last Update
May 21 2025
Active Locations (4)
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1
University Hospitals Antwerp
Antwerp, Antwerp, Belgium, 2000
2
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600
3
Jessa Ziekenhuis
Hasselt, Limburg, Belgium, 3500
4
AZ Sint Lucas
Bruges, West-Vlaanderen, Belgium, 8000