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

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status and phase: Completed; Phase 2

Conditions: Unfavorable Cervix, Cervical Ripening

Treatments: Device: Foley catheter; Drug: PGE2

Study type: Interventional

Funder types: Other

Identifiers

NCT02861079

117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Propess with Foley balloon catheter

Experimental group

Description:

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

Treatment:

Drug: PGE2

Device: Foley catheter

Propess vaginal ovule

Active Comparator group

Description:

10 mg PGE2 vaginal ovule will be inserted to the posterior fornix

Treatment:

Drug: PGE2