Propess Versus Prostin for Induction of Labour in Women With Term PROM

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

Premature rupture of membranes (PROM) at term is a rupture that occurs at term (> 37 weeks) before the start of labor.

The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor in women with term PROM Propess (Controlled release dinoprostone, Vaginal Delivery System) and Prostin E2 (Dinoprostone vaginal Tablet).

Women will be randomised to two treatment groups.

Although some studies support efficacy of the Propess for cervical ripening at term in induction of labor with intact membranes, it has not been well studied in women with PROM at term.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Medical Centre Maribor
• Treatments: Dinoprostone

Criteria

Inclusion Criteria:

• Age 18 years or older

• Gestational age 37 weeks or more

• Singleton pregnancy

• Cephalic presentation

• Unfavorable cervix (BISHOP <6)

• No contraindications for vaginal delivery

• Without uterine surgery

• Without chorioamnionitis

Exclusion Criteria:

• Age less than 18 years

• Multiple gestation

• Previous cesarean section

• Suspected intraamniotic infection

• Any contraindication to vaginal delivery

• Bishop score >7

• Pathological ctg