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

Sara Varea

Status and phase

Completed

Phase 2

Conditions

Preterm Labor With Intact Membranes

Treatments

Drug: placebo

Drug: indomethacin

Study type

Interventional

Funder types

Other

Identifiers

NCT01577121

INDOGEST

Details and patient eligibility

About

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

Full 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

Enrollment

16 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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