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

NCT ID: NCT01577121

Last Updated: 2014-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-09-30

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

Conditions

Preterm Labor With Intact Membranes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

50 mg / 6 hours during 5 days

indomethacin

50 mg/ 6 hours of indomethacin oral use

Group Type: EXPERIMENTAL

indomethacin

Intervention Type: DRUG

50 mg / 6 hours during 5 days

Interventions

indomethacin

50 mg / 6 hours during 5 days

Intervention Type: DRUG

placebo

50 mg / 6 hours during 5 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sara Varea

OTHER

Sponsor Role: lead

Responsible Party

Sara Varea

Clinical Research Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Clinic of Barcelona- Maternity

Barcelona, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35947046 (View on PubMed)

Other Identifiers

INDOGEST

Identifier Type: -

Identifier Source: org_study_id