Foley Catheter Versus Double-balloon Catheter for Cervical Ripening

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Ripening, Pregnancy, High-Risk

Intervention / Treatment
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* Device: mechanical cervical ripening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Foley catheter group<br>mechanical cervical ripening | Device: mechanical cervical ripening<br>* mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon<br>|
| Double-balloon group<br>mechanical cervical ripening | Device: mechanical cervical ripening<br>* mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon<br>|
| Cook cervical ripening balloon<br>mechanical cervical ripening | Device: mechanical cervical ripening<br>* mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon<br>|

What is the study measuring?
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Primary Outcome Measures

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