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Comparing Outpatient and Inpatient Use of a Cervical Balloon for Starting Labor in Low-Risk Pregnancies.

NCT06983535 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2025-05-21

No results posted yet for this study

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 prepare the body for labor. This mechanical method works just as well as using medication but may be safer for the baby, as it reduces the chances of the womb contracting too much (which can cause stress to the baby). Because it's safe and simple, this method could possibly be done at home instead of in the hospital.

What was the aim of the study? The researchers wanted to compare how safe and effective this balloon method is when used at home (outpatient) versus in the hospital (inpatient). They also wanted to know how satisfied women were with each approach.

How was the study done? The study took place at four hospitals in Belgium between 2017 and 2023. It included women with healthy low risk pregnancies who were scheduled for induction for non-urgent reasons, such as being past their due date, having a large baby, or by personal choice after 38 weeks of pregnancy.

The women were randomly placed into two groups:

Outpatient setting: going home after balloon placement.

Inpatient setting: staying in the hospital after balloon placement\<

The main thing researchers measured was whether the baby's heart rate pattern (checked by CTG monitoring) was abnormal after 12 hours. They also looked at how the baby was born (vaginal birth or C-section), how long labor took, whether additional medicine was needed, pain management, and how satisfied the mothers were with the process.

Conditions

  • Induction of Labor

Interventions

DEVICE

cervical balloon catheter

Patients will be randomized to inpatient or outpatient setting while having the cervical ripening balloon catheter

Sponsors & Collaborators

  • AZ Sint-Lucas Brugge

    collaborator OTHER

  • University Hospital, Antwerp

    collaborator OTHER

  • Jessa Hospital

    collaborator OTHER

  • Ziekenhuis Oost-Limburg

    lead OTHER

Principal Investigators

  • Zoe Pieters · Data Science Institute, Hasselt University, Diepenbeek, Belgium.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-15
Primary Completion
2023-11-15
Completion
2024-02-01
FDA Device
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06983535 on ClinicalTrials.gov