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

Compare Prostaglandin E2 Against to Combined Use of Transcervical Foley Catheter Balloon With Vaginal Prostaglandin E2 for Induction of Labor at Term: A Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Unfavorable Cervix, Cervical Ripening
• Intervention / Treatment: Device: Foley catheter; Drug: PGE2

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 2

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • zeynep kamil education and research hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propess with Foley balloon 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	Device: Foley catheter; An 18-F Foley catheter will insert into the endocervical canal and the balloon will fill with 30 mL of saline solution.; Drug: PGE2; 10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.; Other Names: propess
Active Comparator: Propess vaginal ovule; 10 mg PGE2 vaginal ovule will be inserted to the posterior fornix	Drug: PGE2; 10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.; Other Names: propess

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Publications and helpful links

General Publications

• Du C, Liu Y, Liu Y, Ding H, Zhang R, Tan J. Double-balloon catheter vs. dinoprostone vaginal insert for induction of labor with an unfavorable cervix. Arch Gynecol Obstet. 2015 Jun;291(6):1221-7. doi: 10.1007/s00404-014-3547-3. Epub 2014 Nov 19.
• Dalui R, Suri V, Ray P, Gupta I. Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening. Acta Obstet Gynecol Scand. 2005 Apr;84(4):362-7. doi: 10.1111/j.0001-6349.2005.00662.x.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2017
• Primary Completion (Actual): December 25, 2017
• Study Completion (Actual): December 25, 2017

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No