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Clinical trials for Premature rupture of membranes

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44381   clinical trials with a EudraCT protocol, of which   7393   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    18 result(s) found for: Premature rupture of membranes. Displaying page 1 of 1.
    EudraCT Number: 2007-004506-27 Sponsor Protocol Number: 07-029 Start Date*: 2007-12-20
    Sponsor Name:CHU de CAEN
    Full Title: Intérêt de la tocolyse dans la prise en charge des ruptures prématurées des membranes entre 24 et 34 semaines d’aménorrhée.
    Medical condition: premature rupture of membranes
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036603 Premature rupture of membranes LLT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000174-66 Sponsor Protocol Number: APOSTELIV Start Date*: 2012-02-07
    Sponsor Name:Academic Medical Centre
    Full Title: Assessment of Perinatal Outcome by uSe of Tocolysis in Early Labour (APOSTEL IV); Nifedipine versus placebo in the treatment of preterm premature rupture of membranes
    Medical condition: Premature preterm rupture of membranes
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036600 Premature labour PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-002480-30 Sponsor Protocol Number: - Start Date*: 2023-07-18
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    Full Title: PeRinatal Outcomes with ACTive versus expectant management of women with Pre-labor Rupture Of Membranes: a phase III, open-label, randomized controlled multicentric trial
    Medical condition: 1400 Women with PROM at term and a GBS negative swab
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10073024 Preterm premature rupture of membranes PT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-003348-31 Sponsor Protocol Number: 2007/311 Start Date*: 2008-05-15
    Sponsor Name:Department of Woman and Child health, Karolinska University Hospital
    Full Title: Progesterone at imminent premature birth Progesteron vid hotande förtidsbörd
    Medical condition: In this randomised, placebo-controlled pilot study the treatment group (n=30) will recieve a daily application of vaginal gel containing progesterone 90 mg/dose (Crinone, Seronomerck) until rupture...
    Disease:
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Under 18, Adults Gender: Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005180-16 Sponsor Protocol Number: FFIS/2015/02/EV Start Date*: 2016-09-08
    Sponsor Name:Fundación para la Formación e Investigación Sanitaria
    Full Title: Early vaginal progesterone for the prevention of spontaneous preterm birth in twins: A randomised, placebo controlled, double-blinded trial.
    Medical condition: Spontaneous preterm birth in twin pregnancies.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10023555 Labour premature LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) ES (Completed) BG (Completed) IT (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-004482-14 Sponsor Protocol Number: P160917 Start Date*: 2019-08-14
    Sponsor Name:ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)
    Full Title: Tocolysis in the management of preterm premature rupture of membranes before 34 weeks of gestation: a double-blinded randomized controlled trial
    Medical condition: Pregnant women with PPROM at 22 to 33 weeks gestation
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000145-40 Sponsor Protocol Number: versión2.febrero2017 Start Date*: 2017-09-20
    Sponsor Name:montserrat zamora brito
    Full Title: Use of acupuncture for the reduction of hospital admissions in the induction of labor due to chronologically prolonged gestation. ACUPUNT STUDY
    Medical condition: This Clinical Trial will evaluate the efficacy and safety of acupuncture to promote labor in pregnant women who need an induction at birth and thus be able to give answers to all these women who a...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001548-13 Sponsor Protocol Number: BRN-C-2015-01 Start Date*: 2015-09-24
    Sponsor Name:BOIRONSIH
    Full Title: RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL TO MEASURE THE EFFICACY OF ACTAEA RACEMOSA (9CH) AND CAULOPHYLLUM THALICTROIDES (9CH) IN THE FIRST STAGE OF LABOR
    Medical condition: First stage of labor
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-003326-41 Sponsor Protocol Number: 200719 Start Date*: 2016-01-13
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-Blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
    Medical condition: Preterm Labour
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036600 Premature labour PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-001826-13 Sponsor Protocol Number: 200721 Start Date*: 2015-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor
    Medical condition: preterm labor
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036595 Premature delivery PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: BE (Completed) GB (Completed) SE (Completed) ES (Completed) DE (Completed) IT (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-007950-77 Sponsor Protocol Number: OPPTIMUM Start Date*: 2008-07-02
    Sponsor Name:University of Edinburgh and NHS Lothian Health Board
    Full Title: Does progesterone prophylaxis to prevent preterm labour improve outcome? - a randomised double blind placebo controlled trial (OPPTIMUM)
    Medical condition: Preterm labour
    Disease:
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Under 18, Adults Gender: Female
    Trial protocol: GB (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2022-003124-41 Sponsor Protocol Number: 219510 Start Date*: 2023-03-27
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A Phase 3b, non-randomized, open label, multi-country, cohort study to describe the safety of study participants who received RSVPreF3 maternal vaccination (any dose) or controls from previous RSV ...
    Medical condition: Pregnancy related outcomes and events in maternal participants who were vaccinated against RSV or received control, and in their infants
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10070538 Gestational hypertension PT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036485 Pre-eclampsia PT
    25.0 10036585 - Pregnancy, puerperium and perinatal conditions 10086971 Pre-eclampsia with severe features LLT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10070532 Fetal growth restriction LLT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10073024 Preterm premature rupture of membranes PT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10075863 Preterm labor LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10018210 Gestational diabetes mellitus LLT
    20.0 100000004862 10008755 Chorioamnionitis LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10041093 Small for gestational age LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10067508 Low birth weight baby PT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10067509 Very low birth weight baby LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10074164 Extremely low birth weight baby LLT
    20.1 10018065 - General disorders and administration site conditions 10011912 Death neonatal PT
    25.0 10042613 - Surgical and medical procedures 10086969 Medically induced preterm birth PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: FI (Completed) BE (Completed) DE (Completed) FR (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-000456-15 Sponsor Protocol Number: 3518 Start Date*: 2015-05-19
    Sponsor Name:Kings College London [...]
    1. Kings College London
    2. Guys and St Thomas' NHS Foundation Trust
    Full Title: The prevention of pre-term birth in women who develop a short cervix. A multi-centre randomised controlled trial to compare three treatments; cervical cerclage, cervical pessary and vaginal proges...
    Medical condition: Short Cervix in Pregnancy
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004868 10021632 Incompetent cervix LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-005330-14 Sponsor Protocol Number: VAC31518COV2004 Start Date*: 2021-04-06
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: An Open-label, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants.
    Medical condition: Healthy Pregnant Volunteers (Prevention of SARS-CoV-2-mediated COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-001726-22 Sponsor Protocol Number: COLIGROW Start Date*: 2022-12-12
    Sponsor Name:Dr. Ignacio Herraiz García
    Full Title: COok's ballon versus dinoprostone for Labor Induction of term pregnancies with fetal GROWth restriction (COLIGROW study).
    Medical condition: Induction of term pregnancies with fetal growth restriction.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004868 10070532 Fetal growth restriction LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004697-25 Sponsor Protocol Number: V528Nov22 Start Date*: 2020-09-14
    Sponsor Name:The Rotunda Hospital
    Full Title: The Home Induction trial: A randomised open-label trial to assess outpatient induction of labour, and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in nor...
    Medical condition: Normal risk nulliparous women who have no pregnancy-related or medical contraindication to Induction of Labour
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10055563 Labor induction LLT
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001119-38 Sponsor Protocol Number: 116945 Start Date*: 2015-09-21
    Sponsor Name:GlaxoSmithKline
    Full Title: A Phase IV, observer-blind, randomised, cross-over, placebo-controlled, multicentre study to assess the immunogenicity and safety of a single dose of Boostrix? in pregnant women.
    Medical condition: Booster immunisation against diphtheria, tetanus and pertussis diseases. The study population for this study will include pregnant women.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10047976 Whooping cough due to bordetella pertussis (B. pertussis) LLT
    18.0 100000004862 10009663 Clostridium tetani infection LLT
    18.0 100000004862 10054237 Corynebacterium diphtheriae infection LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed) CZ (Completed) FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001918-42 Sponsor Protocol Number: 2009-107(Canadian) Start Date*: 2014-01-17
    Sponsor Name:Ottawa Hospital Research Institute
    Full Title: Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical Trial (FACT) A randomized, double-blind, placebo-controlled, Phase III, international multi-centre study of 4...
    Medical condition: pre-eclampsia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036485 Pre-eclampsia PT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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