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

Phase 2

Completed

• Conditions: Unfavorable Cervix, Cervical Ripening
• Interventions: Device: Foley catheter; Drug: PGE2

• Registration Number: NCT02861079
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief Summary

This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 in induction of labor at term. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.

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.

Study Timeline

• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-10
• Study Start: 2017-08-25
• Primary Completion: 2017-12-25
• Study Completion: 2017-12-25
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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,
7. a category II or III fetal heart rate pattern,
8. anomalous fetus,
9. fetal demise
10. women with immediate delivery indications -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
induction-to- delivery time	the length of time between the beginning of induction and the end of 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	the length of time between the beginning of induction and the onset of 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, Turkey