Completed

NCT Number: NCT02861079

Combined Foley Catheter Balloon and PGE2 Vaginal Ovule 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.

Completed

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Key information

Conditions

Unfavorable Cervix, Cervical Ripening

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Zeynep Kamil Education and Research Hospital

Istanbul, 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.

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,
a category II or III fetal heart rate pattern,
anomalous fetus,
fetal demise
women with immediate delivery indications -

Treatment and study plan

foley catheter

Device

An 18-F Foley catheter will insert into the endocervical canal and the balloon will fill with 30 mL of saline solution.

PGE2

Drug

10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.

Other names: propess

Primary outcomes

induction-to- delivery time

Time frame: 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 outcomes

induction-to-active phase of labor time

Time frame: 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

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Aug 10, 2016
Registry last updated: Feb 1, 2018

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.