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Comparison of placement of the inflated transcervical Foley catheter for 6 or 12 hours in the labour induction of women with one previous Caesarean birth

Foley catheter placement for labour induction in one previous Caesarean with unripe cervices for 6 compared to 12 hours: a randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58643025
Enrollment
126
Registered
2022-01-19
Start date
2022-01-25
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Induction of labour Pregnancy and Childbirth

Interventions

Women with a history of one previous lower segment Caesarean section who are at term with unripe cervixes and have had Foley catheter placed trans-cervically and its balloon inflated for induction of

Sponsors

University Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. One previous transverse lower segment Caesarean delivery 2. Bishop score = 5 3. Age =18 years 4. Term pregnancy >36 weeks gestation 5. Singleton pregnancy 6. Cephalic presentation 7. Intact membrane 8. Reassuring fetal heart rate tracing 9. Absence of significant contraction =2 in 10 minutes 10. Successful Foley catheter insertion

Exclusion criteria

Exclusion criteria: 1. History of hysterotomy/uterine perforation/myomectomy 2. Preference for repeat caesarean section 3. Latex allergy 4. Estimated fetal weight 4 kg 5. Placenta previa including minor previa 6. Major fetal malformations 7. Contraindication for vaginal delivery 8. Patient who is suspected COVID-19 infection or SARS-CoV-2 positive 9. Inability to given consent

Design outcomes

Primary

MeasureTime frame
Foley catheter insertion to birth interval (hours) measured using patient records

Secondary

MeasureTime frame
Maternal outcomes: 1. Estimate of the readiness of the cervix for labour measured using Bishop score calculated before insertion of the catheter and after removal of the catheter 2. Use of additional method for cervical ripening measured from patient records after removal of the catheter 3. Time to delivery after Foley removal measured from patient records between removal of the catheter and delivery 4. Mode of delivery measured from patient records at delivery 5. Indication for caesarean section measured from patient record at delivery 6. Duration of oxytocin infusion measured from patient records between delivery to discharge 7. Maternal satisfaction-based allocation to intervention until birth measured using 11-point Verbal Numerical Rating Score (VNRS) at delivery 8. Blood loss during delivery measured from patient records at delivery 9. Third -or fourth-degree tear measured from patient records at delivery 10. Maternal infection measured from patient records between admission and discharge 11. Use of regional analgesia in labour measured from patient records at delivery 12. Length of hospital stay measured from patient records between hospital admission and discharge 13. Need for ICU admission measured from patient records between hospital admission and discharge 14. Cardiorespiratory arrest measured from patient record between hospital admission and discharge 15. Need of hysterectomy measured from patient record between admission and discharge. 16. Uterine scar rupture / dehiscence measured from patient record between hospital admission and discharge Neonatal outcomes: 1. Neonatal health measured using Apgar score at 1 and 5 min after delivery 2. Need for NICU admission measured from patient records between hospital admission and discharge 3. Cord pH measured at delivery 4. Neonatal sepsis measured from patient records between delivery and discharge 5. Birth weight measured from patient records at delivery 6. Birth trauma measured from

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026