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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foley catheter group | mechanical cervical ripening |
| |
| Double-balloon group | mechanical cervical ripening |
| |
| Cook cervical ripening balloon | mechanical cervical ripening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mechanical cervical ripening | Device | mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women with unfavorable cervices and need to deliver for maternal or fetal health condition.
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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 |
|---|---|---|---|
| 19656148 | Background | Pennell CE, Henderson JJ, O'Neill MJ, McChlery S, Doherty DA, Dickinson JE. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG. 2009 Oct;116(11):1443-52. doi: 10.1111/j.1471-0528.2009.02279.x. Epub 2009 Jul 28. | |
| 27436681 |
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| Sayed Ahmed WA, Ibrahim ZM, Ashor OE, Mohamed ML, Ahmed MR, Elshahat AM. Use of the Foley catheter versus a double balloon cervical ripening catheter in pre-induction cervical ripening in postdate primigravidae. J Obstet Gynaecol Res. 2016 Nov;42(11):1489-1494. doi: 10.1111/jog.13086. Epub 2016 Jul 19. |