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A comparison of the efficacy of concurrent use of intracervical foley catheter balloon and mifepristone to intracervical foley catheter alone for cervical ripening at term: a triple-blind randomized control trial

A comparison of the efficacy of concurrent use of intracervical foley catheter balloon and mifepristone to intracervical foley catheter alone for cervical ripening at term: a triple-blind randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202306488956692
Enrollment
112
Registered
2023-06-05
Start date
2022-06-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Pregnancy and Childbirth

Interventions

THE EFFICACY OF CONCURRENT USE OF INTRACERVICAL FOLEY CATHETER BALLOON AND MIFEPRISTONE
EFFICACY OF INTRACERVICAL FOLEY CATHETRE BALLOON AND ORAL PLACEBO

Sponsors

ESE ADIGBA ONODJOHWOYOVWE
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: All Consented pregnant women with the following: 1. Term pregnancy 2. Singleton foetus in cephalic presentation 3. Intact foetal membrane 4. Normal non stress test 5. Bishop Score of < 6 6. No contraindication to vaginal delivery 7. No known allergy or contraindication to Mifepristone.

Exclusion criteria

Exclusion criteria: 1. Preterm pregnancy 2. Prolonged pregnancy (=42 weeks gestation) 3. Prelabour rupture of foetal membrane 4. Previous caesarean section or major uterine surgery 5. Bishop score = 6 at admission 6. Foetal malpresentation 7. Multiple pregnancy 8. Intrauterine foetal death, 9. Severe intrauterine growth restriction 10. Severe oligohydramnios 11. Major congenital anomalies 12. Allergy or contraindication to use of Mifepristone 13. Abnormal or non-reassuring non stress test 14. Contraindication to vaginal delivery

Design outcomes

Primary

MeasureTime frame
The Primary outcome measure will be proportion of women that will have favourable Bishop’s Score within 12 hours—

Secondary

MeasureTime frame
secondary outcomes will be balloon expulsion time, spontaneous onset of labour, need for oxytocin, vaginal delivery rate, cervical ripening-delivery interval, caesarean section rate and fetomaternal outcomes such as APGAR score < 7 at 1 minutes and 5 minutes, NICU admission and maternal drug side effects.—

Countries

Nigeria

Contacts

Public ContactEse Adigba Onodjohwoyovwe

Senior Registrar

adigbaese@gmail.com2348068115905

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026