Transcervical Foley Catheter with a 50-mL versus 80-mL Single Balloon Volume for Cervical Ripening in Late and Postterm Nulliparous Women: A Single Center Randomized Clinical Trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202404666076601

Enrollment

120

Registered

2024-04-02

Start date

2021-08-26

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

50 mL of transcervical Foley Catheter balloon volume

80 mL Foley catheter

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Nulliparous women (no prior pregnancy > 20 weeks gestation) Aged = 18 years. Gestational age of 41+0 weeks or beyond, based on the last known monthly period. Carrying a single live intrauterine pregnancy in cephalic presentation, with intact amniotic membranes. Demonstrating a reassuring fetal heart rate pattern on cardiotocograph (CTG) tracing. Nonsignificant contractions (two or more in 10 minutes). Unfavourable cervix (Bishop score < 6).

Exclusion criteria

Exclusion criteria: History of antepartum bleeding. Use of another ripening agent before FC placement. Active lower urinary tract infections. known or suspected latex allergy. Placenta previa. Significant fetal anomalies. Contraindications to vaginal delivery. Known or newly diagnosed human immunodeficiency virus (HIV) infection.

Design outcomes

Primary

Measure	Time frame
The proportion of women who achieved a Bishop score = 6 at 24 hours after catheter placement.	—

Secondary

Measure	Time frame
Proportion of vaginal deliveries within 24 hours of induction.	—

Countries

Kenya

Contacts

Public ContactFranklin Okumu

Registrar Reproductive Health

franklinokumu2@gmail.com00254710308577

Outcome results

None listed

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