NCT01577121

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Sara Varea · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Preterm Labor With Intact Membranes

Interventions

Type	Name	Description
DRUG	indomethacin	50 mg / 6 hours during 5 days
DRUG	placebo	50 mg / 6 hours during 5 days

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-04-13
• Last updated: 2014-10-21

Locations

1 site across 1 country: Spain