Clinical trial NCT04743297: Propess Versus Prostin for Induction of Labour in Women With Term PROM
Official title: Labour Induction With the Propess Vaginal Delivery System vs. Labour Induction With the Prostin Vaginal Tablet in Case of a Prelabour Rupture of Membranes. PESTIBOR Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Premature Rupture of Membranes at Term
Induction of Labour
Keywords: Induction
PROM
Propess
Prostin
Lead sponsor: University Medical Centre Maribor
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 526
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Induction to Delivery Interval
timeFrame: 24 hours
measure: Induction to Onset of labor Interval
timeFrame: 24 hours
Secondary outcomes:
measure: Frequency of Cesarean Sections
timeFrame: 24 hours
measure: Frequency of Failed Induction
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Maribor University Medical Centre
name: Veronika Anzeljc
role: STUDY_CHAIR
References:
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citation: National Collaborating Centre for Women's and Children's Health. National Institute for Health and Care Excellence: Clinical Guidelines. Intrapartum Care: Care of Healthy Women and Their Babies During Childbirth. London: National Institute for Health and Care Excellence (UK) Copyright (c) 2014 National Collaborating Centre for Women's and Children's Health.; 2014
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