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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02861079

Enrollment

300

Registered

2016-08-10

Start date

2017-08-25

Completion date

2017-12-25

Last updated

2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unfavorable Cervix, Cervical Ripening

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.

Interventions

DEVICEFoley catheter

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

DRUGPGE2

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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 -

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026