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

NCT06983535 | Terminated FDA Device

• 1 other identifier: GYN2016.01
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 4

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 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

Keywords

induction of labor; cervical ripening; balloon catheter

Outcome Measures

Primary Outcomes (1)

• Fetal wellbeing

  The primary outcome was foetal wellbeing assessed by cardiotocography (CTG) immediately after balloon insertion and balloon removal (12 hours after insertion). The CTG could be normal or not normal. The CTG was reported as not normal in case of a baseline rise, decelerations (even if they were not repeated decelerations) or decreased variability. The second CTG assessment was performed earlier in case of vaginal bleeding, fluid loss, onset of regular painful contractions, balloon expulsion or in any other case judged clinically relevant by the obstetrician

  12 hours

Study Arms (2)

Inpatient

ACTIVE COMPARATOR

Patient in this arm were randomized to stay in the hospital during cervical balloon ripening

Device: cervical balloon catheter

Outpatient

ACTIVE COMPARATOR

Patients in this arm were randomized to ambulant home setting during cervical ripening

Device: cervical balloon catheter

Interventions

cervical balloon catheter DEVICE

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

Inpatient; Outpatient

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• : 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.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• AZ Sint-Lucas Brugge: collaborator
• University Hospital, Antwerp: collaborator
• Jessa Hospital: collaborator

Study Sites (4)

University Hospitals Antwerp

Antwerp, Antwerp, 2000, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

AZ Sint Lucas

Bruges, West-Vlaanderen, 8000, Belgium

Location

Related Publications (1)

• Alfirevic Z, Keeney E, Dowswell T, Welton NJ, Medley N, Dias S, Jones LV, Caldwell DM. Methods to induce labour: a systematic review, network meta-analysis and cost-effectiveness analysis. BJOG. 2016 Aug;123(9):1462-70. doi: 10.1111/1471-0528.13981. Epub 2016 Mar 22.

  PMID: 27001034 BACKGROUND

Related Links

• European Perinatal Health Report: Core Indicators of the Health and Care of Pregnant Women and Babies in Europe from 2015 to 2019. Euro-Peristat

Study Officials

• Zoe Pieters

  Data Science Institute, Hasselt University, Diepenbeek, Belgium.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 21, 2025
• Study Start: August 15, 2016
• Primary Completion: November 15, 2023
• Study Completion: February 1, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 05/2017-11/2043
• Access Criteria: Only the central study team will have access

Locations

BE (4)