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

University Medical Centre Maribor

Status and phase: Unknown; Phase 4

Conditions: Premature Rupture of Membranes at Term; Induction of Labour

Treatments: Drug: Prostaglandin E2 (Propess); Drug: Prostaglandin E2 (Prostin)

Study type: Interventional

Funder types: Other

Identifiers

NCT04743297

IRP-2020/01-04

Details and patient eligibility

About

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.

Full description

The study is going to include all pregnant women with in-term PROM (after week 37 of pregnancy) without contractions if they meet the inclusion criteria. If the cervix is still non-inducible after 4-6 hours and there are no contractions, the medication to be administered to them will be determined by means of computer randomization. The success rate of induction with Propess vs. Prostin tablets will be compared. Soon after PROM, there can be the onset of contractions and cervix dilation that lead to childbirth.

In case of some pregnant women, there are no contractions and cervix dilation even after the event despite PROM and water breaking. If the status remains unchanged, the risk of intrauterine infection, fetus infection, and later on an infection of the newborn increases. The expecting mother can also eventually lose hope for a successful vaginal birth and starts thinking about having a caesarean delivery. To avoid that, the investigators use medications that accelerate the onset of vaginal birth in clinical practice.

The investigators know several ways to induce labour after PROM. References give no clear and reliable data on the best approach. The investigators can use medications such as oxytocin, dinoprostone, or misoprostol.

Our ward has been using Prostin 3 mg (dinoprostone) vaginal tablets to induce labour in case of PROM for several years. They have proven to be an efficient and safe procedure in our clinical practice.

Propess is used for the induction of labor with intact membranes. Based on the information from references and according to our experience, the medication is highly effective and safe, as well as easy to use.

Our study aims at establishing whether it can also be used with pregnant women with PROM.

Enrollment: 526 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

526 participants in 2 patient groups

Propess Vaginal Delivery System

Active Comparator group

Description:

Propess - Prostaglandin E2 Vaginal Delivery System. Slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h.

Treatment:

Drug: Prostaglandin E2 (Propess)

Prostin Tablet

Active Comparator group

Description:

Prostaglandin E2 Vaginal Tablet 3 mg dinoprostone

Treatment:

Drug: Prostaglandin E2 (Prostin)