Propess Versus Prostin for Induction of Labour in Women With Term PROM
NCT ID: NCT04743297
Last Updated: 2021-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
526 participants
INTERVENTIONAL
2021-03-31
2023-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Induction of Labor in Term Pregnancies With Unfavourable Cervix
NCT04280874
Dinoprostone Induction vs. Expectant Management After PROM at Term
NCT05430711
Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38
NCT01916291
Prostin and Propess in Induction of Labor
NCT01635439
24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction
NCT00843362
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Propess Vaginal Delivery System
Propess - Prostaglandin E2 Vaginal Delivery System. Slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h.
Prostaglandin E2 (Propess)
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.
Prostin Tablet
Prostaglandin E2 Vaginal Tablet 3 mg dinoprostone
Prostaglandin E2 (Prostin)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prostaglandin E2 (Propess)
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.
Prostaglandin E2 (Prostin)
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Multiple gestation
* Previous cesarean section
* Suspected intraamniotic infection
* Any contraindication to vaginal delivery
* Bishop score \>7
* Pathological ctg
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Medical Centre Maribor
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Veronika Anzeljc
Role: STUDY_CHAIR
Maribor University Medical Centre
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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
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.
Zlatnik FJ. Management of premature rupture of membranes at term. Obstet Gynecol Clin North Am. 1992 Jun;19(2):353-64.
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.
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.
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.
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.
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.
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.
Shirley M. Dinoprostone Vaginal Insert: A Review in Cervical Ripening. Drugs. 2018 Oct;78(15):1615-1624. doi: 10.1007/s40265-018-0995-2.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRP-2020/01-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.