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Tugging the balloon every three hours to check for dislodgement during the Foley catheter labour induction of women who had previously given birth

Tugging the balloon every three hours during the Foley catheter labour induction of multiparas: a randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17782392
Enrollment
220
Registered
2022-11-24
Start date
2022-12-07
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of labour in multiparas with unripe cervixes using Foley catheter balloon Pregnancy and Childbirth

Interventions

The participant information sheet will be given to all potential recruits and any inquiries by the participants will be answered by the recruiting care provider. Written consent will be obtained from

Sponsors

University of Malaya
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Multiparous women (at least 1 vaginal delivery = 24 weeks) 2. Age = 18 years 3. Gestational age = 37 weeks 4. Singleton pregnancy 5. Cephalic presentation 6. Intact membrane 7. Reassuring fetal heart rate tracing 8. Absence of significant contraction = 2 in 10 minutes 9. Successful Foley catheter insertion for induction of labour

Exclusion criteria

Exclusion criteria: 1. History of caesarean delivery, hysterotomy, uterine perforation or previous myomectomy 2. Latex allergy 3. Estimated fetal weight 4kg 4. Known major fetal malformations 5. Contraindications for vaginal delivery 6. Patient who is suspected of harbouring COVID-19 infection or is COVID-19 positive

Design outcomes

Primary

MeasureTime frame
Induction to delivery interval measured using the time from the insertion of the Foley catheter until delivery, at a baseline of 48 hours

Secondary

MeasureTime frame
Maternal satisfaction with the birth process after labour induction measured using a questionnaire, 24 hours after the end of the trial

Countries

Malaysia

Contacts

Public ContactNoor Fadzliana Mohd Zin
fadzliana_86@yahoo.com+60162433588

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026