Skip to content

Cervical ripening for induction of labour using 30ml versus 60ml Foley's balloon catheter in Ebonyi State, Nigeria: A randomized controlled trial

Cervical ripening for induction of labour using 30ml versus 60ml Foley's balloon catheter in Ebonyi State, Nigeria: A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201911698481916
Enrollment
260
Registered
2019-11-19
Start date
2019-07-10
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

Group A Foleys catheter to be inflated with 30ml of sterile water for cervical ripening
Group B Foleys catheter to beinflated with 60ml of sterile water for cervical ripening

Sponsors

NNABUGWU ALFRED ADIELE
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Term pregnancy (37 - 41+6 weeks’ gestational age) singleton fetus vertex presenting fetus intact fetal membranes unfavorable cervix selected for cervical ripening with extra-amniotic Foley’s catheter.

Exclusion criteria

Exclusion criteria: • Ruptured fetal membranes • Previous uterine surgery • Low lying placenta • Multiple pregnancy • HIV positive mothers • Malpresenting fetuses • Presence of painful, regular uterine contractions • Patients that opted for use of epidural analgesia in labour • Parturients presenting with favourable cervix • Fetal anomaly • Patients who do not consent to the study.

Design outcomes

Primary

MeasureTime frame
1.Time taken to achieve favorable Bishop Score 2.Time taken for patient to attain active phase parameter 3. Induction-delivery interval

Secondary

MeasureTime frame
1. Mode of delivery (vaginal or caesarean section) 2. Maternal complications ( cervical laceration, postpartum hemorrhage) 3. Maternal satisfaction 4. Fetal outcome ( Apgar score in 1st and 5th minutes, neonatal intensive care admission, seizures, stillbirth or neonatal death) 5. Number of times the procedure was done before favorable cervix was attained

Countries

Nigeria

Contacts

Public ContactChidebe Anikwe

Public Enquires

drchideanikwechristian@gmail.com+2348064165965

Outcome results

None listed

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