Foley Catheter Versus Double-balloon Catheter for Cervical Ripening

Completed

• Conditions: Cervical Ripening; Pregnancy, High-Risk
• Interventions: Device: mechanical cervical ripening

• Registration Number: NCT04687436
• Lead Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Brief 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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 222

Inclusion Criteria

• Age between 18 and 40
• Singleton pregnancy
• Vertex presentation
• Bishop score <6
• Using a Foley catheter or cook balloon for cervical ripening
• High-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders)

Exclusion Criteria

• Being younger than 18 or over 40
• Communication problems (foreign national)
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Foley catheter group	mechanical cervical ripening	mechanical cervical ripening
Cook cervical ripening balloon	mechanical cervical ripening	mechanical cervical ripening
Double-balloon group	mechanical cervical ripening	mechanical cervical ripening

Primary Outcome Measures

Name	Time	Method
vaginal delivery rate	until the patient gives birth	the difference in vaginal birth rate between groups
vaginal delivery within 24 hours	from the time of cervical ripening catheter insertion to the 24 hours	the difference in vaginal delivery within 24 hours rate between groups
bishop score	at the time of removing the cervical ripening catheter or when the balloon was expelled spontaneously	bishop score \>6 is accepted as successful ripening. (max. 10, and the higher bishop score means better ripening has been occurred.)

Trial Locations

Locations (1)

University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital; 🇹🇷 Ankara, Turkey