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Completed

NCT Number: NCT03629548

Comparing Foley Catheter Balloon With Early Amniotomy for Induction of Labor at Term

This study evaluates the intervention for induction of labor with low bishop scores . One group will be induced by transcervical Foley catheter balloon and vaginal PGE2 and other group will be induced by early amniotomy and PGE2 vaginal ovule for induction of labor at term.

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Key information

Conditions

Induced Vaginal Delivery

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Kamil Education and Research Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

About this study

An unfavorable cervix during induction decreases the success rate of labor induction and vaginal delivery. Therefore it is required to apply cervical ripening methods for unfavorable cervices. Application of transcervical Foley catheter is an effective mechanical method and has the advantages of lower cost and lowest rate of fetal heart rate changes due to tachysystole compared with PGE1 and PGE2. Despite the advantages of mechanical methods, PGE1 and PGE2 are reported to be more effective than mechanical methods to achieve vaginal delivery within 24 hours. Although there are a lot of studies comparing PGE1, PGE2 and transcervical Foley balloon catheter separately and PGE1 combined with transcervical Foley balloon catheter, less is known about combined usage of PGE2 and transcervical Foley balloon catheter. Early amniotomy is another effective method to ripen cervix. we aim to evaluate which method is superior to another.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • singleton pregnancy,
  • gestational age ≥37 weeks,
  • intact membranes,
  • cephalic presentation,
  • bishop score ≤5,
  • had obstetrical indications for induction of labor,
  • had less than three uterine contractions in every 10 minutes.

Exclusion criteria

  • Patients who had contraindications for vaginal delivery,
  • previous uterine surgery,
  • fetal malpresentation,
  • multifetal pregnancy,
  • more than three contractions in 10 minutes,
  • contraindications to prostaglandins,

Treatment and study plan

Early Amniotomy

Procedure

10 mg PGE2 vaginal ovul will be inserted to the posterior fornix. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook.

foley catheter balloon placement

Device

an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix and after placement of balloon catheter 10 mg PGE2 vaginal ovul will be inserted to the posterior fornix

Other names: mechanic and medical method

Primary outcomes

  1. induction-to- delivery time

    Time frame: from the beginning of induction until the labor

    the length of time between the beginning of induction and the end of labor

Secondary outcomes

  1. induction-to-active phase of labor time

    Time frame: from the beginning of induction until the labor

    the length of time between the beginning of induction and the onset of labor

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study title

Comparing Combined Foley Catheter Balloon and PGE2 Vaginal Ovule With Early Amniotomy and PGE2 for Induction of Labor at Term: A Randomized Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2018
Registry last updated
Feb 4, 2021

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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