Evaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation (INDOGEST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Fundacion Clinic per a la Recerca Biomédica
Sponsor:
Information provided by (Responsible Party):
Sara Varea, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01577121
First received: April 10, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

To demonstrate if indomethacin associated to conventional treatment for preterm labor is useful to delay delivery and to improve neonatal morbimortality in women with preterm labor with high risk of intraamniotic inflammation


Condition Intervention Phase
Preterm Labor With Intact Membranes
Drug: indomethacin
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Utility of Indomethacin as Support Treatment in Women With Preterm Labor With Intact Membranes and High Risk of Intraamniotic Inflammation

Resource links provided by NLM:


Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • Gestational age at delivery [ Time Frame: before than 42 weeks of gestation ] [ Designated as safety issue: No ]
    number of weeks and days at delivery


Secondary Outcome Measures:
  • proportion of patients with spontaneous preterm delivery before 34 weeks of gestation [ Time Frame: at the end of study (maximum 1 year) ] [ Designated as safety issue: No ]
    the participants will be followed until delivery. The proportion of patiens with spontaneous preterm delivery before week 34 will be available at the end of the study, once the last patient delivers.

  • Incidence of adverse events [ Time Frame: 1 year (end of study) ] [ Designated as safety issue: Yes ]
    adverse events will be registered

  • Latency from admission to delivery [ Time Frame: between initial admission and delivery (before 42 weeks of gestation) ] [ Designated as safety issue: No ]
    Latency from admission to delivery will be calculated

  • IL-6 levels in amniotic fluid and umbilical cord blood [ Time Frame: delivery (maximum 42 weeks of gestational age) ] [ Designated as safety issue: No ]
    the investigators will determine the level of IL-6 in different samples

  • Number of emergency visits [ Time Frame: between initial admission and delivery (before 42 weeks of gestation) ] [ Designated as safety issue: No ]
    Number of visits to emergency area will be registered

  • Neonatal morbidity [ Time Frame: at the end of the study (1 year) ] [ Designated as safety issue: No ]

    neonatal morbidity will be registered:

    • admission to Neonatal Intensive Care Unit (NICU)
    • number of days of NICU admission
    • respiratory distress syndrome
    • intraventricular haemorrage
    • early onset neonatal sepsis
    • necrotizing enterocolitis
    • late neonatal sepsis
    • neonatal death.

  • Neonatal death [ Time Frame: at the end of the study (1 year) ] [ Designated as safety issue: Yes ]
    Neonatal deaths will be registered


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
50 mg / 6 hours during 5 days
Experimental: indomethacin
50 mg/ 6 hours of indomethacin oral use
Drug: indomethacin
50 mg / 6 hours during 5 days

Detailed Description:

Randomised patients would be assigned to receive indomethacin either placebo oral use(50 mg every 6 hours during 5 days) to evaluate the efficacy of indomethacin as complementary treatment to increase the gestational age at delivery in women admitted with preterm labor and intact membranes with high risk of intraamniotic inflammation, defined as a gestational age at admission less than 28.0 weeks or those women from 28-32.0 weeks with a sonographic cervical length less than 15 mm

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant women with preterm labor admitted to hospital and treated with tocolysis
  • pregnant women less than 28.0 and those women from 28.0 to 32.0 with a sonographic cervical length < 15 mm
  • single pregnancy
  • normal amniotic fluid
  • normal arterial ductus

Exclusion Criteria:

  • Age below 18 years
  • previous use of indomethacin in the index pregnancy
  • chorioamnionitis, preterm prelabour rupture of membranes or those fetal or maternal pathologies which could be responsible of an iatrogenic preterm delivery.
  • oligohydramnios
  • allergy to NSAID
  • previous history of gastrointestinal bleeding
  • use of NSAID contraindicated
  • not adherence to the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577121

Locations
Spain
Hospital Clinic of Barcelona- Maternity Recruiting
Barcelona, Spain, 08028
Contact: Montse Palacio, MD    +34932275400    mpalacio@clinic.ub.es   
Contact: Teresa Cobo, MD    +34932275400    tcobo@clinic.ub.es   
Principal Investigator: Montse Palacio, MD         
Sponsors and Collaborators
Sara Varea
  More Information

No publications provided

Responsible Party: Sara Varea, Clinical Research Manager, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier: NCT01577121     History of Changes
Other Study ID Numbers: INDOGEST
Study First Received: April 10, 2012
Last Updated: April 14, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundacion Clinic per a la Recerca Biomédica:
Preterm labor

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Inflammation
Pathologic Processes
Pregnancy Complications
Indomethacin
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014