NCT04743297

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
526

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

1.8 years

First QC Date

January 26, 2021

Last Update Submit

February 9, 2021

Conditions

Premature Rupture of Membranes at TermInduction of Labour

Keywords

InductionPROMPropessProstin

Outcome Measures

Primary Outcomes (2)

  • Induction to Delivery Interval

    24 hours

  • Induction to Onset of labor Interval

    24 hours

Secondary Outcomes (2)

  • Frequency of Cesarean Sections

    24 hours

  • Frequency of Failed Induction

    24 hours

Study Arms (2)

Propess Vaginal Delivery System

ACTIVE COMPARATOR

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

Drug: Prostaglandin E2 (Propess)

Prostin Tablet

ACTIVE COMPARATOR

Prostaglandin E2 Vaginal Tablet 3 mg dinoprostone

Drug: Prostaglandin E2 (Prostin)

Interventions

Prostaglandin E2 (Propess)DRUG

Propess - The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour or at the occurrence of hyperstimulation.

Also known as: dinoprostone
Propess Vaginal Delivery System
Prostaglandin E2 (Prostin)DRUG

Prostin - 3 mg vaginal tablet is placed in the posterior vaginal fornix. Dose can be repeated every 8 hours till onset of active labour or the occurrence of hyper-stimulation.

Also known as: dinoprostone
Prostin Tablet

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age less than 18 years
  • Multiple gestation
  • Previous cesarean section
  • Suspected intraamniotic infection
  • Any contraindication to vaginal delivery
  • Bishop score \>7
  • Pathological ctg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Mynarek M, Bjellmo S, Lydersen S, Strand KM, Afset JE, Andersen GL, Vik T. Prelabor rupture of membranes and the association with cerebral palsy in term born children: a national registry-based cohort study. BMC Pregnancy Childbirth. 2020 Jan 31;20(1):67. doi: 10.1186/s12884-020-2751-3.

    PMID: 32005186BACKGROUND

  • 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

    BACKGROUND

  • Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.

    PMID: 8598837BACKGROUND

  • Zlatnik FJ. Management of premature rupture of membranes at term. Obstet Gynecol Clin North Am. 1992 Jun;19(2):353-64.

    PMID: 1630743BACKGROUND

  • Geethanath RM, Ahmed I, Abu-Harb M, Onwuneme C, McGarry K, Hinshaw K. Intrapartum antibiotics for prolonged rupture of membranes at term to prevent Group B Streptococcal sepsis. J Obstet Gynaecol. 2019 Jul;39(5):619-622. doi: 10.1080/01443615.2018.1550474. Epub 2019 Mar 27.

    PMID: 30917724BACKGROUND

  • Ivars J, Garabedian C, Devos P, Therby D, Carlier S, Deruelle P, Subtil D. Simplified Bishop score including parity predicts successful induction of labor. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:309-14. doi: 10.1016/j.ejogrb.2016.06.007. Epub 2016 Jul 5.

    PMID: 27423032BACKGROUND

  • Athiel Y, Crequit S, Bongiorno M, Sanyan S, Renevier B. Term prelabor rupture of membranes: Foley catheter versus dinoprostone as ripening agent. J Gynecol Obstet Hum Reprod. 2020 Oct;49(8):101834. doi: 10.1016/j.jogoh.2020.101834. Epub 2020 Jun 22.

    PMID: 32585393BACKGROUND

  • Freret TS, Chacon KM, Bryant AS, Kaimal AJ, Clapp MA. Oxytocin Compared to Buccal Misoprostol for Induction of Labor after Term Prelabor Rupture of Membranes. Am J Perinatol. 2021 Feb;38(3):224-230. doi: 10.1055/s-0039-1696642. Epub 2019 Sep 6.

    PMID: 31491801BACKGROUND

  • Cheung PC, Yeo EL, Wong KS, Tang LC. Oral misoprostol for induction of labor in prelabor rupture of membranes (PROM) at term: a randomized control trial. Acta Obstet Gynecol Scand. 2006;85(9):1128-33. doi: 10.1080/00016340600589636.

    PMID: 16929421BACKGROUND

  • Hu YP, Zhou D, Li M, Wang Y, Wang L, Sun GQ, Xiao M. Use of labor induction with dinoprostone vaginal suppositories in pregnant women with gestational hypertension. J Obstet Gynaecol Res. 2019 Nov;45(11):2185-2192. doi: 10.1111/jog.14092. Epub 2019 Aug 27.

    PMID: 31456315BACKGROUND

  • Shirley M. Dinoprostone Vaginal Insert: A Review in Cervical Ripening. Drugs. 2018 Oct;78(15):1615-1624. doi: 10.1007/s40265-018-0995-2.

    PMID: 30317521BACKGROUND

  • Pajntar M, Lučovnik M. Normalni porod in vodenje poroda. v knjigi Nosečnost in vodenje poroda. Ured. Pajntar M, Novak Antolič Ž, Lučovnik M. Medicinski razgledi 2015. Tretja dopolnjena izdaja. 231-50.

    BACKGROUND

MeSH Terms

Interventions

DinoprostoneKLK15 protein, human

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Veronika Anzeljc

    Maribor University Medical Centre

    STUDY CHAIR

Central Study Contacts

Veronika Anzeljc

CONTACT

+ 386 2 321 21 73veronika.anzeljc@ukc-mb.si

Faris Mujezinović

CONTACT

+ 386 2 321 24 08faris.mujezinovic@ukc-mb.si

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 8, 2021

Study Start

March 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share