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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Preterm Labor With Intact Membranes

Intervention / Treatment
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* Drug: indomethacin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: placebo<br>* 50 mg / 6 hours during 5 days<br>|
| Experimental: indomethacin<br>50 mg/ 6 hours of indomethacin oral use | Drug: indomethacin<br>* 50 mg / 6 hours during 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at delivery | number of weeks and days at delivery | before than 42 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with spontaneous preterm delivery before 34 weeks of gestation | 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. | at the end of study (maximum 1 year) | 
| Incidence of adverse events | adverse events will be registered | 1 year (end of study) | 
| Latency from admission to delivery | Latency from admission to delivery will be calculated | between initial admission and delivery (before 42 weeks of gestation) | 
| IL-6 levels in amniotic fluid and umbilical cord blood | the investigators will determine the level of IL-6 in different samples | delivery (maximum 42 weeks of gestational age) | 
| Number of emergency visits | Number of visits to emergency area will be registered | between initial admission and delivery (before 42 weeks of gestation) | 
| Neonatal morbidity | 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. | at the end of the study (1 year) | 
| Neonatal death | Neonatal deaths will be registered | at the end of the study (1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm labor