A Randomized Trial of Induction Methods in Premature Rupture of Membranes

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status: Unknown

Conditions: Induction of Labor Affected Fetus / Newborn; Preterm Premature Rupture of Fetal Membranes

Treatments: Device: Foley balloon catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03744078

47

Details and patient eligibility

About

This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 induction in premature rupture of membranes. 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. singleton pregnancy,
2. gestational age ≥34 weeks,
3. rupture of membranes,
4. cephalic presentation,
5. bishop score ≤5,
6. 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)

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200 participants in 2 patient groups

PGE2 with Foley balloon catheter

Active Comparator group

Description:

10 mg PGE2 vaginal ovul will be inserted to the posterior fornix and an 18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix

Treatment:

Device: Foley balloon catheter

PGE2 vaginal ovule

No Intervention group

Description:

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