Status:
COMPLETED
Foley Catheter Versus Double-balloon Catheter for Cervical Ripening
Lead Sponsor:
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Conditions:
Cervical Ripening
Pregnancy, High-Risk
Eligibility:
FEMALE
18-40 years
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, sing...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT04687436
Start Date
July 1 2020
End Date
November 30 2020
Last Update
February 7 2022
Active Locations (1)
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1
University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
Ankara, Turkey (Türkiye), 06000