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

Sara Varea16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Preterm Labor With Intact Membranes

Interventions

indomethacinDRUG

50 mg / 6 hours during 5 days

placeboDRUG

50 mg / 6 hours during 5 days

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clinic of Barcelona- Maternity

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Gestational age at delivery

number of weeks and days at delivery

Time frame: before than 42 weeks of gestation

Secondary Outcomes

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.

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

Incidence of adverse events

adverse events will be registered

Time frame: 1 year (end of study)

Latency from admission to delivery

Latency from admission to delivery will be calculated

Time frame: 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

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

Number of emergency visits

Number of visits to emergency area will be registered

Time frame: 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.

Data from ClinicalTrials.gov

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