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

Not Applicable

Completed

• Conditions: Induced Vaginal Delivery
• Interventions: Procedure: early amniotomy; Device: foley catheter balloon placement

• Registration Number: NCT03629548
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-08-11
• Study First Posted: 2018-08-14
• Study Start: 2018-08-15
• Primary Completion: 2019-09-15
• Study Completion: 2019-10-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

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

Exclusion Criteria

1. Patients who had contraindications for vaginal delivery,
2. previous uterine surgery,
3. fetal malpresentation,
4. multifetal pregnancy,
5. more than three contractions in 10 minutes,
6. contraindications to prostaglandins,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early amniotomy plus dinoprostone	early amniotomy	10 mg dinoprostone 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 balloon catheter plus dinoprostone	foley catheter balloon placement	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 dinoprostone vaginal ovul will be inserted to the posterior fornix

Primary Outcome Measures

Name	Time	Method
induction-to- delivery time	from the beginning of induction until the labor	the length of time between the beginning of induction and the end of labor

Secondary Outcome Measures

Name	Time	Method
induction-to-active phase of labor time	from the beginning of induction until the labor	the length of time between the beginning of induction and the onset of labor

Trial Locations

Locations (1)

Zeynep Kamil Education and Research Hospital; 🇹🇷 Istanbul, Uskudar, Turkey