Evaluation of the Utility of Indomethacin as Support Treatment in Women With Preterm Labor With Intact Membranes and High Risk of Intraamniotic Inflammation
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Gestational age at delivery
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
placebo
Intervention: placebo (Drug)
indomethacin
50 mg/ 6 hours of indomethacin oral use
Intervention: indomethacin (Drug)
Outcomes
Primary Outcomes
Gestational age at delivery
Time Frame: before than 42 weeks of gestation
number of weeks and days at delivery
Secondary Outcomes
- proportion of patients with spontaneous preterm delivery before 34 weeks of gestation(at the end of study (maximum 1 year))
- Number of emergency visits(between initial admission and delivery (before 42 weeks of gestation))
- Neonatal morbidity(at the end of the study (1 year))
- Incidence of adverse events(1 year (end of study))
- Neonatal death(at the end of the study (1 year))
- Latency from admission to delivery(between initial admission and delivery (before 42 weeks of gestation))
- IL-6 levels in amniotic fluid and umbilical cord blood(delivery (maximum 42 weeks of gestational age))
Investigators
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica