Foley Catheter Versus Double-balloon Catheter for Cervical Ripening

NCT04687436 | Completed

• 1 other identifier: mechanical cervical ripening
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Ripening; Pregnancy, High-Risk

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Foley catheter group

mechanical cervical ripening

Device: mechanical cervical ripening

Double-balloon group

mechanical cervical ripening

Device: mechanical cervical ripening

Cook cervical ripening balloon

mechanical cervical ripening

Device: mechanical cervical ripening

Interventions

mechanical cervical ripening DEVICE

mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon

Cook cervical ripening balloon; Double-balloon group; Foley catheter group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women with unfavorable cervices and need to deliver for maternal or fetal health condition.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 19656148 BACKGROUND

• 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.

  PMID: 27436681 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 29, 2020
• Study Start: July 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: February 7, 2022

Record last verified: 2022-01

Locations

TU (1)