Clinical trial NCT01577121: Evaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation
Official title: Evaluation of the Utility of Indomethacin as Support Treatment in Women With Preterm Labor With Intact Membranes and High Risk of Intraamniotic Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preterm Labor With Intact Membranes
Keywords: Preterm labor
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Gestational age at delivery
timeFrame: before than 42 weeks of gestation
Secondary outcomes:
measure: proportion of patients with spontaneous preterm delivery before 34 weeks of gestation
timeFrame: at the end of study (maximum 1 year)
measure: Incidence of adverse events
timeFrame: 1 year (end of study)
measure: Latency from admission to delivery
timeFrame: between initial admission and delivery (before 42 weeks of gestation)
measure: IL-6 levels in amniotic fluid and umbilical cord blood
timeFrame: delivery (maximum 42 weeks of gestational age)
measure: Number of emergency visits
timeFrame: between initial admission and delivery (before 42 weeks of gestation)
measure: Neonatal morbidity
timeFrame: at the end of the study (1 year)
measure: Neonatal death
timeFrame: at the end of the study (1 year)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona- Maternity
Study officials:
References:
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.