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.
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

April 10, 2012
April 14, 2014
April 2012
September 2014   (final data collection date for primary outcome measure)
Gestational age at delivery [ Time Frame: before than 42 weeks of gestation ] [ Designated as safety issue: No ]
number of weeks and days at delivery
Gestational age at labor [ Time Frame: before than 42 weeks of gestation ] [ Designated as safety issue: No ]
number of weeks and days in the day of labor
Complete list of historical versions of study NCT01577121 on ClinicalTrials.gov Archive Site
  • 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
  • proportion of patients with labor before week 34 of gestation [ Time Frame: at the end of study (maximum 1 year) ] [ Designated as safety issue: No ]
    the participants will be followed until the labor. The proportion of patiens with labor before week 34 would be available at the end of the study; once the last patient woull arrive to labor.
  • Incidence of adverse events [ Time Frame: 1 year (end of study) ] [ Designated as safety issue: Yes ]
    there will be a registration of adverse events
  • number of days between admission to hospital due to Threatened preterm labor to labor [ Time Frame: between initial admission and labor (before 42 weeks of gestation) ] [ Designated as safety issue: No ]
    the patients will be recruited during an admission to the hospital due to a threatened of premature labor; investigators will stimate the number of days between that admission and the labor day
  • IL-6 levels in fetal plasma, amniotic liquid and umbilical cord blood [ Time Frame: labor (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 labor (before 42 weeks of gestation) ] [ Designated as safety issue: No ]
    the investigators will count the number of visits to hospital due to an emergency reason
  • Neonatal morbility [ Time Frame: at the end of the study (1 year) ] [ Designated as safety issue: No ]
    the investigators will collect after the labor information about neonatal morbility: if an admission is needed, respiratory distress, congenital sepsis,...
  • exitus neonatal [ Time Frame: at the end of the study (1 year) ] [ Designated as safety issue: Yes ]
    the investigators will register the number of neonatal exitus
Not Provided
Not Provided
 
Evaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation
Evaluation of the Utility of Indomethacin as Support Treatment in Women With Preterm Labor With Intact Membranes 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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Preterm Labor With Intact Membranes
  • Drug: indomethacin
    50 mg / 6 hours during 5 days
  • Drug: placebo
    50 mg / 6 hours during 5 days
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: indomethacin
    50 mg/ 6 hours of indomethacin oral use
    Intervention: Drug: indomethacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Not Provided
Spain
 
NCT01577121
INDOGEST
No
Sara Varea, Fundació Clínic per la Recerca Biomèdica
Sara Varea
Not Provided
Not Provided
Fundacion Clinic per a la Recerca Biomédica
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP