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Foley Catheter Versus Double-balloon Catheter for Cervical Ripening

Launched by ETLIK ZUBEYDE HANIM WOMEN'S HEALTH CARE, TRAINING AND RESEARCH HOSPITAL · Dec 23, 2020

Trial Information

Current as of April 28, 2025

Completed

Keywords

ClinConnect Summary

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 labo...

Gender

FEMALE

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

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

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital is a leading healthcare institution dedicated to advancing women's health through comprehensive clinical care, innovative research, and specialized training programs. With a focus on evidence-based practices, the hospital aims to enhance the quality of care for women across various health concerns, including reproductive health, maternal care, and gynecological conditions. The institution is committed to fostering collaboration among healthcare professionals and researchers to improve patient outcomes and contribute to the broader medical community through impactful clinical trials and educational initiatives.

Locations

Ankara, , Turkey

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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