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

Phase 2

Completed

• Conditions: Preterm Labor With Intact Membranes
• Interventions: Drug: placebo; Drug: indomethacin

• Registration Number: NCT01577121
• Lead Sponsor: Sara Varea

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-13
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-20
• Last Update Posted: 2014-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
indomethacin	indomethacin	50 mg/ 6 hours of indomethacin oral use

Primary Outcome Measures

Name	Time	Method
Gestational age at delivery	before than 42 weeks of gestation	number of weeks and days at delivery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clinic of Barcelona- Maternity; 🇪🇸 Barcelona, Spain