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Tugging the foley's catheter every three hours in the labor induction of women with a previous caesarean section

Tugging the foley's catheter every three hours in the labor induction of women with a previous caesarean section: A randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16633990
Enrollment
126
Registered
2023-03-28
Start date
2023-04-01
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Women who had a prior caesarean delivery undergoing cervical ripening in labour induction Pregnancy and Childbirth

Interventions

Participants will be randomly allocated by sealed envelope to receive either: 1. During Foley balloon cervical ripening, the catheter will be tugged intermittently, every three hours to check for disl

Sponsors

University Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. One previous uncomplicated transverse lower segment cesarean section 2. Age = 18 years 3. Gestational age of = 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 insertion for induction of labour

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. Induction (Foley insertion) to delivery interval 2. Maternal satisfaction with birth experience after labor induction by 11-point 0-10 Visual Numerical Rating Scale.

Secondary

MeasureTime frame
Maternal outcomes 1. Change in bishop score after intervention (obtained from hospital record after hospital discharge) 2. Use of additional method for cervical ripening (obtained from hospital record after hospital discharge) 3. Time to delivery after Foley removal/expulsion (obtained from hospital record after hospital discharge) 4. Mode of delivery (obtained from hospital record after hospital discharge) 4.1. spontaneous vaginal 4.2. vacuum 4.3. forceps 4.4. caesarean section 5. Indication for operative delivery (obtained from hospital record after hospital discharge) 6. Duration of oxytocin infusion (obtained from hospital record after hospital discharge) 7. Blood loss during delivery (obtained from hospital record after hospital discharge) 8. Third-or fourth-degree tear (obtained from hospital record after hospital discharge) 9. Maternal infection (obtained from hospital record after hospital discharge) 10. Use of regional analgesia in labor (epidural) (obtained from hospital record after hospital discharge) 11. Length of hospital stay (obtained from hospital record after hospital discharge) 12. ICU admission (obtained from hospital record after hospital discharge) 13. Cardiorespiratory arrest (obtained from hospital record after hospital discharge) 14. Hysterectomy (obtained from hospital record after hospital discharge) 15. Maternal satisfaction with the allocated intervention Neonatal outcomes (obtained from hospital record after hospital discharge) 16. Apgar score at 1 and 5 minutes (obtained from hospital record after hospital discharge) 17. NICU admission (obtained from hospital record after hospital discharge) 18. Cord artery pH (obtained from hospital record after hospital discharge) 19. Neonatal sepsis (obtained from hospital record after hospital discharge) 20. Birth weight (obtained from hospital record after hospital discharge) 21. Birth trauma (obtained from hospital record after hospital discharge) 22. Hypoxic ischaemic encephalopathy/need for t

Countries

Malaysia

Contacts

Public ContactYunesh Krishnan
yunesh@ummc.edu.my+60 11-33275017

Outcome results

None listed

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