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OSSAI'S TRIAL

A comparison of the effect of intracervical Foley catheter balloon volumes 30ml versus 60ml on cervical ripening among pregnant women planned for induction of labour at term: a triple blind randomized controlled trial.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202512871635509
Enrollment
192
Registered
2025-12-15
Start date
2024-01-17
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Pregnancy and Childbirth

Interventions

30mL Foley catheter balloon
60mL Foley catheter balloon

Sponsors

OSSAI CHUKWUMA ANTHONY
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: • Singleton pregnancy • Cephalic presentation • Intact fetal membrane • Gestational age =37weeks • Bishop score = 5 • Reactive non-stress test • All consenting patients

Exclusion criteria

Exclusion criteria: • Multiple pregnancy • Abnormal fetal presentation • Ruptured fetal membrane • Gestational age < 37 weeks • Intra-uterine fetal death • Previous extensive uterine surgery • Contra-indication to vaginal delivery • Non-reactive non-stress test(NST) • Bishop score =6 • Patient’s refusal • HIV positive status • Fetal structural anomaly.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the proportion of women that achieve favourable cervix at the 12th hour post Foley catheter balloon insertion or spontaneous expulsion

Secondary

MeasureTime frame
The secondary outcome measures will include; Foley catheter insertion to expulsion interval, Induction to delivery interval, catheter balloon rupture, iatrogenic membrane rupture, need for additional ripening agent, Vaginal delivery rate, cesarean section rate and participants’ satisfaction with the use of the various inflatable catheter balloon volumes among pregnant women at term, who had their Foley catheter balloon inflated to 30 and 60ml respectively for pre-induction cervical ripening at term

Countries

Nigeria

Contacts

Public ContactUFUOMA EYEREGBA

Consultant Obstetrician

itsufuoma2000@yahoo.com+2348038794901

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026