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Completed

NCT Number: NCT04687436

Foley Catheter Versus Double-balloon Catheter for Cervical Ripening

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.

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Key information

Conditions

Cervical Ripening Pregnancy, High-Risk

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Ankara, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical cervical ripening

Device

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

Primary outcomes

  1. bishop score

    Time frame: at the time of removing the cervical ripening catheter or when the balloon was expelled spontaneously

    bishop score >6 is accepted as successful ripening. (max. 10, and the higher bishop score means better ripening has been occurred.)

  2. vaginal delivery rate

    Time frame: until the patient gives birth

    the difference in vaginal birth rate between groups

  3. vaginal delivery within 24 hours

    Time frame: from the time of cervical ripening catheter insertion to the 24 hours

    the difference in vaginal delivery within 24 hours rate between groups

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Foley Catheter Versus Double-balloon Catheter for Cervical Ripening in Women With a High-risk Pregnancy

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 29, 2020
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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