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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foley catheter group | pregnant women who were applied Foley catheter for cervical ripening |
| |
| Cook balloon catheter group | pregnant women who were applied Cook balloon catheter for cervical ripening |
| |
| Modified double-balloon Foley catheter group | pregnant women who were applied modified double-balloon Foley catheter for cervical ripening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mechanical cervical ripening | Device | mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women who were applied one of the mechanical cervical ripening methods, Foley catheter, Cook balloon catheter or modified double-balloon Foley catheter
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital | Ankara | 06000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30175373 | Background | Lim SE, Tan TL, Ng GYH, Tagore S, Kyaw EEP, Yeo GSH. Patient satisfaction with the cervical ripening balloon as a method for induction of labour: a randomised controlled trial. Singapore Med J. 2018 Aug;59(8):419-424. doi: 10.11622/smedj.2018097. | |
| 12521850 | Background | Tomlinson AJ, Archer PA, Hobson S. Induction of labour: a comparison of two methods with particular concern to patient acceptability. J Obstet Gynaecol. 2001 May;21(3):239-41. doi: 10.1080/01443610120046314. |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| 28303340 | Background | Akca A, Corbacioglu Esmer A, Ozyurek ES, Aydin A, Korkmaz N, Gorgen H, Akbayir O. The influence of the systematic birth preparation program on childbirth satisfaction. Arch Gynecol Obstet. 2017 May;295(5):1127-1133. doi: 10.1007/s00404-017-4345-5. Epub 2017 Mar 16. |