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.
- Conditions
- Pregnancy and Childbirth
- Registration Number
- PACTR202404666076601
- Lead Sponsor
- Franklin Okumu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 120
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method