Patient Satisfaction With Mechanical Cervical Ripening
- Conditions
- Satisfaction, Patient
- Interventions
- Device: mechanical cervical ripening
- Registration Number
- NCT04683081
- Lead Sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- 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 satisfaction
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 34
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cook balloon catheter group mechanical cervical ripening pregnant women who were applied Cook balloon catheter for cervical ripening Foley catheter group mechanical cervical ripening pregnant women who were applied Foley catheter for cervical ripening Modified double-balloon Foley catheter group mechanical cervical ripening pregnant women who were applied modified double-balloon Foley catheter for cervical ripening
- Primary Outcome Measures
Name Time Method Patient satisfaction level within the first 24 hours after birth Overall patient satisfaction score is obteined by VAS score system and Salmon's items list
Pain scores immediately after application Pain scores are obteined by VAS score system
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
🇹🇷Ankara, Turkey