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Clinical trials for Preterm Birth

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   44335   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 ).  
     
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    155 result(s) found for: Preterm Birth. Displaying page 1 of 8.
    1  2  3  4  5  6  7  8  Next»
    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: 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: 2015-003220-31 Sponsor Protocol Number: 54463 Start Date*: 2016-06-21
    Sponsor Name:VU medical center, Amsterdam
    Full Title: Low dose aspirin in the Prevention of Recurrent Spontaneous Preterm Labour – the APRIL study
    Medical condition: Prevention of recurrent spontaneous preterm birth
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    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: 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: 2022-004195-42 Sponsor Protocol Number: FIT-05 Start Date*: 2023-04-13
    Sponsor Name:Elgan Pharma Ltd
    Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest
    Medical condition: Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10025479 Malabsorption syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) SE (Ongoing) ES (Ongoing) NL (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004890-29 Sponsor Protocol Number: FIT-PIV Start Date*: 2023-03-09
    Sponsor Name:Elgan Pharma Ltd
    Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
    Medical condition: Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10025479 Malabsorption syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) SE (Trial now transitioned) NL (Trial now transitioned) AT (Trial now transitioned)
    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: 2009-016731-34 Sponsor Protocol Number: CRO1413 Start Date*: 2010-01-08
    Sponsor Name:Imperial College
    Full Title: Amino acid regimen and intravenous lipid composition in preterm parenteral nutrition: a randomised double blind controlled trial of Nutritional Evaluation and Optimisation in Neonates.
    Medical condition: Preterm birth
    Disease: Version SOC Term Classification Code Term Level
    12.0 10036594 Premature birth LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-003445-17 Sponsor Protocol Number: BBG001 Start Date*: 2009-05-12
    Sponsor Name:Queen Mary, University of London
    Full Title: The probiotic Bifidobacterium breve strain BBG-01 admistered early to preterm infants to prevent infection, necrotising enterocolitis and death.
    Medical condition: Necrotising enterocolitis in the preterm baby Late-onset (>72h of age) blood stream infection in the preterm baby Death of preterm babies before discharge from hospital
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    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: 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: 2017-005021-21 Sponsor Protocol Number: PIPIN Start Date*: 2018-03-26
    Sponsor Name:University of Edinburgh [...]
    1. University of Edinburgh
    2. NHS Lothian
    Full Title: A feasibility study investigating pravastatin for the prevention of preterm birth in women
    Medical condition: Preterm Birth
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004868 10032405 Other preterm infants LLT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-005568-24 Sponsor Protocol Number: NL47657-044-14 Start Date*: 2014-05-28
    Sponsor Name:Medisch Spectrum Twente
    Full Title: The reduction of Apneas in Preterm Infants: Low-Flow versus Caffeine
    Medical condition: Apnea Of Prematurity
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-023909-35 Sponsor Protocol Number: BVT.BSSL-030 Start Date*: 2011-06-24
    Sponsor Name:Swedish Orphan Biovitrum AB (publ)
    Full Title: A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Wee...
    Medical condition: Prevention of growth retardation due to lack of bile salt-stimulated lipase in enteral nutrition
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036590 Premature baby PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Prematurely Ended) SE (Prematurely Ended) DE (Prematurely Ended) HU (Completed) FR (Ongoing) CZ (Completed) PL (Prematurely Ended) ES (Prematurely Ended) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001007-72 Sponsor Protocol Number: 80-84800-98-41027 Start Date*: 2017-07-06
    Sponsor Name:Amsterdam UMC location AMC
    Full Title: Atosiban versus placebo in the treatment of late threatened preterm birth (APOSTEL VIII).
    Medical condition: Neonatal outcome in threatened preterm birth between 30 and 34 weeks of gestation.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    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: 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: 2007-007550-66 Sponsor Protocol Number: Emulipid Start Date*: 2008-02-21
    Sponsor Name:OSPEDALE POLICLINICO S. MATTEO
    Full Title: Lipidic emulsions influence on immune response of pre-term VLBW newborns treated with total parenteral nutrition
    Medical condition: very low birth weight newborn
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036590 Premature baby LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
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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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