Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Preterm Labor

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    28 result(s) found for: Preterm Labor. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2013-002884-24 Sponsor Protocol Number: Quadruple-P-Study Start Date*: 2017-09-06
    Sponsor Name:AMC
    Full Title: Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length
    Medical condition: preterm birth
    Disease: Version SOC Term Classification Code Term Level
    20.1 10036585 - Pregnancy, puerperium and perinatal conditions 10023555 Labour premature LLT
    20.1 10036585 - Pregnancy, puerperium and perinatal conditions 10023545 Labor premature LLT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036594 Premature birth LLT
    20.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036600 Premature labour PT
    20.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036599 Premature labor LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-005563-33 Sponsor Protocol Number: 80-82310-98-09056 Start Date*: 2009-10-22
    Sponsor Name:ZonMw
    Full Title: Costs and effects of fibronectin as a triage in women with threatened preterm labour.
    Medical condition: Preterm Labour
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036600 Premature labour LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000129-61 Sponsor Protocol Number: ASB-treat-study Start Date*: 2011-11-14
    Sponsor Name:AMC Amsterdam
    Full Title: ASB treat study: Preventing preterm birth with nitrofurantoin: Costs and effects of screening and treating healthy women for asymptomatic bacteriuria’
    Medical condition: Preterm birth<34wks and pyelonefritis in singleton healthy pregnancies
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036600 LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-005987-15 Sponsor Protocol Number: The Triple P study Start Date*: 2009-10-22
    Sponsor Name:AMC Amsterdam
    Full Title: Preventing preterm birth: Costs and effects of screening of healthy women with a singleton pregnancy for a short cervical length.
    Medical condition: Preterm birth with healthy singleton pregnancies
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036600 Premature labour LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (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: 2006-005807-32 Sponsor Protocol Number: OTA105256 Start Date*: 2007-06-29
    Sponsor Name:GlaxoSmithKline Research and Development
    Full Title: A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously and the ph...
    Medical condition: Uncomplicated preterm labour
    Disease: Version SOC Term Classification Code Term Level
    8.1 10023555 Labour premature LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Prematurely Ended) LT (Prematurely Ended) ES (Completed) FR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2013-002561-19 Sponsor Protocol Number: 1 Start Date*: 2014-03-06
    Sponsor Name:Medizinische Universität Wien, Univ.Klinik f.Frauenheilkunde,Abt. f.Geburtshilfe und Feto-maternale Medizin
    Full Title: A prospective, double blind, randomised, placebo controlled trial to evaluate the effect of a long term tokolysis with atosiban on the pregnancy outcome. A pilot study.
    Medical condition: Premature uterine contractions premature labor
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004868 10068718 Premature uterine contractions LLT
    16.1 100000004868 10036599 Premature labor LLT
    Population Age: Adults Gender: Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    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: 2009-011782-92 Sponsor Protocol Number: OTA113142 Start Date*: 2009-06-26
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously in healthy...
    Medical condition: Preterm labour
    Disease: Version SOC Term Classification Code Term Level
    9.1 10023555 Labour premature LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    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: 2017-002579-25 Sponsor Protocol Number: 17-OBE022-003 Start Date*: 2017-10-31
    Sponsor Name:ObsEva SA
    Full Title: A phase 2a, double-blind, parallel group, randomised, placebo controlled, proof of concept study to assess the efficacy, safety and pharmacokinetics of OBE022 added-on to atosiban, after oral admin...
    Medical condition: oral treatment of threatened spontaneous preterm labour in weeks 24 to 34 of pregnancy
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004868 10075863 Preterm labor LLT
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-003884-22 Sponsor Protocol Number: COL-1620-300 Start Date*: 2005-10-21
    Sponsor Name:Columbia Laboratories, Inc
    Full Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Prochieve® 8% Progesterone Gel in Preventing Preterm Delivery in Pre...
    Medical condition: Increased-Risk for Preterm Delivery
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    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: 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: 2008-007498-19 Sponsor Protocol Number: COL-1620-302 Start Date*: 2009-09-17
    Sponsor Name:Columbia Laboratories, Inc
    Full Title: The Effect of Vaginal Progesterone Administration in the prevention of Preterm Birth in Women with Short Cervix, [also Known as: Vaginal progesterone bioadhesive gel (Prochieve)® Extending Gestatio...
    Medical condition: Preterm birth (less than or equal to 32 6/7 weeks gestation)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-004880-36 Sponsor Protocol Number: CRB Start Date*: 2013-06-17
    Sponsor Name:Medizinische Universität Graz, Klinische Abteilung für Geburtshilfe, Univ. Klinik für Frauenheilkunde und Geburtshilfe
    Full Title: Efficacy of induction of labor on term using a double balloon catheter compared to Dinoprostone vaginal-insert – a multicenter randomized controlled trial.
    Medical condition: Gestational age between the 37th and 42th gestation week
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-014696-52 Sponsor Protocol Number: 17P-ES-003 Start Date*: 2009-12-31
    Sponsor Name:AMAG Pharma USA Inc.
    Full Title: A PHASE 3B, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF HYDROXYPROGESTERONE CAPROATE INJECTION, 250 MG/ML, VERSUS VEHICLE FOR THE PREVENTION OF PRETERM BIRTH IN WOMEN WITH A PREVIOUS SINGLETON ...
    Medical condition: Preterm birth
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10036594 Premature birth LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Completed) ES (Completed) IT (Completed) CZ (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002547-15 Sponsor Protocol Number: UTM/2012 Start Date*: 2012-11-13
    Sponsor Name:Instituto de Investigacion Sanitaria La Fe
    Full Title: UTILITY OF THE ocolytict MAINTENANCE TREATMENT IN THE MANAGEMENT OF THE THREAT OF PREMATURE
    Medical condition: Threat Preterm labor
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-015782-30 Sponsor Protocol Number: APOSTELIII Start Date*: 2012-11-23
    Sponsor Name:Academic Medical Centre
    Full Title: Nifedipine versus Atosiban in the treatment of threatened preterm labour
    Medical condition: Threatened preterm labour
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004868 10056173 Threatened premature labour, antepartum LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    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 (Ongoing) ES (Completed)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue May 06 09:39:15 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA