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Completed

NCT Number: NCT01577121

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

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

Completed

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Key information

Conditions

Preterm Labor With Intact Membranes Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Clinic of Barcelona- Maternity

Barcelona, 08028, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indomethacin

Drug

50 mg / 6 hours during 5 days

Placebo

Drug

50 mg / 6 hours during 5 days

Primary outcomes

  1. Gestational age at delivery

    Time frame: before than 42 weeks of gestation

    number of weeks and days at delivery

Secondary outcomes

  1. proportion of patients with spontaneous preterm delivery before 34 weeks of gestation

    Time frame: at the end of study (maximum 1 year)

    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.

  2. Incidence of adverse events

    Time frame: 1 year (end of study)

    adverse events will be registered

  3. Latency from admission to delivery

    Time frame: between initial admission and delivery (before 42 weeks of gestation)

    Latency from admission to delivery will be calculated

  4. IL-6 levels in amniotic fluid and umbilical cord blood

    Time frame: delivery (maximum 42 weeks of gestational age)

    the investigators will determine the level of IL-6 in different samples

  5. Number of emergency visits

    Time frame: between initial admission and delivery (before 42 weeks of gestation)

    Number of visits to emergency area will be registered

  6. Neonatal morbidity

    Time frame: at the end of the study (1 year)

    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.

  7. Neonatal death

    Time frame: at the end of the study (1 year)

    Neonatal deaths will be registered

Sponsors and collaborators

Lead sponsor

Sara Varea

Other

Registry information

Official study title

Evaluation of the Utility of Indomethacin as Support Treatment in Women With Preterm Labor With Intact Membranes and High Risk of Intraamniotic Inflammation

Acronym: INDOGEST

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 13, 2012
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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