Clinical trial NCT04687436: Foley Catheter Versus Double-balloon Catheter for Cervical Ripening
Official title: Foley Catheter Versus Double-balloon Catheter for Cervical Ripening in Women With a High-risk Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Ripening
Pregnancy, High-Risk
Lead sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 222
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with unfavorable cervices and need to deliver for maternal or fetal health condition.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: bishop score
timeFrame: at the time of removing the cervical ripening catheter or when the balloon was expelled spontaneously
measure: vaginal delivery rate
timeFrame: until the patient gives birth
measure: vaginal delivery within 24 hours
timeFrame: from the time of cervical ripening catheter insertion to the 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
Study officials:
References:
citation: 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.
citation: 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.