Overview

This trial is active, not recruiting.

Condition unfavorable cervix, cervical ripening
Treatments foley catheter, pge2
Phase phase 2
Sponsor Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Start date August 2016
End date October 2016
Trial size 250 participants
Trial identifier NCT02861079, 144

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
10 mg PGE2 vaginal ovul and an 18-F Foley catheter which filling with 30 mL of saline solution
foley catheter
An 18-F Foley catheter will insert into the endocervical canal and the balloon will fill with 30 mL of saline solution.
pge2 propess
10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.
(Active Comparator)
10 mg PGE2 vaginal ovul
pge2 propess
10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.

Primary Outcomes

Measure
induction-to- delivery time
time frame: the length of time between the beginning of induction and the end of labor

Secondary Outcomes

Measure
induction-to-active phase of labor time
time frame: the length of time between the beginning of induction and the onset of labor

Eligibility Criteria

Female participants from 18 years up to 40 years old.

Inclusion Criteria: 1. singleton pregnancy, 2. gestational age ≥34 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 -

Additional Information

Official title Compare Prostaglandin E2 Against to Combined Transcervical Foley Catheter Balloon and Vaginal Prostaglandin E2 for Induction of Labor at Term: A Randomized Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Zeynep Kamil Maternity and Pediatric Research and Training Hospital.