Status:
COMPLETED
Patient Satisfaction With Mechanical Cervical Ripening
Lead Sponsor:
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Conditions:
Satisfaction, Patient
Eligibility:
FEMALE
18-40 years
Brief Summary
In this study, we aimed to compare three mechanical methods such as foley catheter, cook balloon catheter and modified double-balloon Foley catheter for cervical ripening in terms of patient satisfact...
Detailed Description
This is a prospective observational study. The planned sample size is 34 pregnant women per group with 90% power and 0.05 alpha error. VAS score systems and Salmon's item list were used to evaluate t...
Eligibility Criteria
Inclusion
- Age between 18 and 40
- Singleton pregnancy
- Vertex presentation
- Bishop score \<6
- Using a Foley catheter cook balloon catheter or modified double-balloon Foley catheter 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
- Bishop score \>6
- Being at active labor
- Multifetal pregnancy
- Non-vertex presentation
- Scarred uterus (cesarean or myomectomy)
- Known fetal structural or chromosomal anomaly
- Presence of non-reassuring fetal cardiotocography before cervical ripening
- Regional anesthesia during the first stage
- Operative delivery
- Presence of maternal, fetal or neonatal complication.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 20 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04683081
Start Date
March 1 2020
End Date
May 20 2021
Last Update
February 26 2025
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