Comparing Foley Catheter Balloon With Early Amniotomy for Induction of Labor at Term

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status: Completed

Conditions: Induced Vaginal Delivery

Treatments: Procedure: early amniotomy; Device: foley catheter balloon placement

Study type: Interventional

Funder types: Other

Identifiers

NCT03629548

48

Details and patient eligibility

About

This study evaluates the intervention for induction of labor with low bishop scores . One group will be induced by transcervical Foley catheter balloon and vaginal PGE2 and other group will be induced by early amniotomy and PGE2 vaginal ovule for induction of labor at term.

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. Early amniotomy is another effective method to ripen cervix. we aim to evaluate which method is superior to another.

Enrollment: 250 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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

early amniotomy plus dinoprostone

Active Comparator group

Description:

10 mg dinoprostone vaginal ovul will be inserted to the posterior fornix. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook.

Treatment:

Procedure: early amniotomy

foley balloon catheter plus dinoprostone

Experimental group

Description:

an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix and after placement of balloon catheter 10 mg dinoprostone vaginal ovul will be inserted to the posterior fornix

Treatment:

Device: foley catheter balloon placement