Placement of the inflated transcervical Foley catheter for 6 compared with 12 hours in labour induction of women with previous childbirth

6 hours vs 12 hours of Foley’s catheter placement for labour induction in multiparous women with unripe cervices: a randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN99979127

Enrollment

220

Registered

2022-01-18

Start date

2022-01-24

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

Parous women at term with unripe cervixes and who had Foley catheter inserted trans-cervically and its balloon inflated for induction of labour will be randomized to scheduled catheter removal at A)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Multiparous women (at least 1 prior vaginal delivery of 24 weeks or more gestation) 2. Age =18 years 3. Term pregnancy >36 weeks gestation 4. Singleton pregnancy 5. Cephalic presentation 6. Intact membranes 7. Reassuring fetal heart tracing 8. Absence of significant contraction =2 in 10 minutes 9. Successful Foley insertion for IOL 10. Bishop score =5

Exclusion criteria

Exclusion criteria: 1. History of caesarean delivery, hysterotomy, uterine perforation or myomectomy 2. Latex allergy 3. Estimated Fetal weight 4kg 4. Known fetal major malformations 5. Contraindication for vaginal delivery 6. Patient who is suspected to have Covid 19 infection or SARS-CoV-2 positive

Design outcomes

Primary

Measure	Time frame
Measured after birth: 1. Foley’s catheter insertion to delivery interval (min) using patient records 2. Maternal satisfaction with the labour induction process (using an 11-point 0 to 10 visual numerical rating scale)	—

Secondary

Measure	Time frame
Measured using patient records: Maternal outcomes: 1. Requirement of induction of labour measured by Bishop score before and after intervention 2. Use of additional method for cervical ripening 3. Time to delivery after Foley’s catheter removal 4. Mode of delivery 5. Indication for caesarean section 6. Duration of oxytocin infusion 7. Blood loss during delivery 8. Third -or fourth-degree tear 9. Maternal infection before hospital discharge 10. Use of regional analgesia in labour 11. Length of hospital stay (days) 12. ICU admission before hospital discharge 13. Cardiorespiratory arrest before hospital discharge 14. Hysterectomy before hospital discharge Neonatal outcomes: 1. Apgar score at 1 and 5 minutes 2. NICU admission before hospital discharge 3. Cord pH 4. Neonatal sepsis before hospital discharge 5. Birth weight (kg) 6. Birth trauma 7. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia before hospital discharge	—

Measure

Time frame

Measured using patient records: Maternal outcomes: 1. Requirement of induction of labour measured by Bishop score before and after intervention 2. Use of additional method for cervical ripening 3. Time to delivery after Foley’s catheter removal 4. Mode of delivery 5. Indication for caesarean section 6. Duration of oxytocin infusion 7. Blood loss during delivery 8. Third -or fourth-degree tear 9. Maternal infection before hospital discharge 10. Use of regional analgesia in labour 11. Length of hospital stay (days) 12. ICU admission before hospital discharge 13. Cardiorespiratory arrest before hospital discharge 14. Hysterectomy before hospital discharge Neonatal outcomes: 1. Apgar score at 1 and 5 minutes 2. NICU admission before hospital discharge 3. Cord pH 4. Neonatal sepsis before hospital discharge 5. Birth weight (kg) 6. Birth trauma 7. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia before hospital discharge

—

Countries

Malaysia

Outcome results

None listed

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