NCT04687436

Foley Catheter Versus Double-balloon Catheter for Cervical Ripening

Foley Catheter Versus Double-balloon Catheter for Cervical Ripening in Women With a High-risk Pregnancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 222 (actual)
• Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare pregnancy results which were used foley catheter or double-balloon catheter for cervical ripening among high-risk pregnant women.

Detailed description

This is a prospective observational study. The planned sample size was calculated as 109 patients per group with 80% power and 0.05 alpha error. The inclusion criteria are age between 18 and 40, singleton pregnancy, vertex presentation, bishop score \<6, using a foley catheter or cook balloon for cervical ripening and high-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders). The exclusion criteria are being younger than 18 or over 40, communication problems, bishop score \>6, being at active labor, multifetal pregnancy, non-vertex presentation, scarred uterus (cesarean or myomectomy), fetal structural or chromosomal anomaly, non-reassuring fetal cardiotocography before cervical ripening, regional anesthesia during the first stage. The primary outcomes are the rate of bishop score \>6 after ripening, vaginal delivery rate and vaginal delivery within 24 hours of the initiation of ripening.

Conditions

• Cervical Ripening
• Pregnancy, High-Risk

Interventions

Type	Name	Description
DEVICE	mechanical cervical ripening	mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2020-12-29
• Last updated: 2022-02-07

Locations

1 site across 1 country: Turkey (Türkiye)