Patient Satisfaction With Mechanical Cervical Ripening

Study Overview
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Brief Summary
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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 satisfaction

Detailed Description
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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 the satisfaction level. The inclusion criteria are 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 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), 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. The primary outcomes are the differences in satisfaction level between methods with using either the VAS score system or Salmon's item list and pain scores. The secondary outcomes are the effects of giving birth within 24 hours, parity status, the length of the first stage of labor education level and cesarean section due to failed induction on the satisfaction level.

Official Title
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Cervical Ripening: a Comparison of Three Mechanical Methods in Term of Patient Satisfaction

Conditions
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Satisfaction, Patient

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 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 Criteria: 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.

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>pregnant women who were applied Foley catheter for cervical ripening | Device: mechanical cervical ripening<br>* mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery<br>|
| Cook balloon catheter group<br>pregnant women who were applied Cook balloon catheter for cervical ripening | Device: mechanical cervical ripening<br>* mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery<br>|
| Modified double-balloon Foley catheter group<br>pregnant women who were applied modified double-balloon Foley catheter for cervical ripening | Device: mechanical cervical ripening<br>* mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction level | Overall patient satisfaction score is obteined by VAS score system and Salmon's items list | within the first 24 hours after birth | 
| Pain scores | Pain scores are obteined by VAS score system | immediately after application |