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

NCT01577121 | Completed Phase 2

• 1 other identifier: INDOGEST
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Preterm Labor With Intact Membranes

Keywords

Preterm labor

Outcome Measures

Primary Outcomes (1)

• Gestational age at delivery

  number of weeks and days at delivery

  before than 42 weeks of gestation

Secondary Outcomes (7)

• proportion of patients with spontaneous preterm delivery before 34 weeks of gestation

  at the end of study (maximum 1 year)

• Incidence of adverse events

  1 year (end of study)

• Latency from admission to delivery

  between initial admission and delivery (before 42 weeks of gestation)

• IL-6 levels in amniotic fluid and umbilical cord blood

  delivery (maximum 42 weeks of gestational age)

• Number of emergency visits

  between initial admission and delivery (before 42 weeks of gestation)

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: placebo

indomethacin

EXPERIMENTAL

50 mg/ 6 hours of indomethacin oral use

Drug: indomethacin

Interventions

indomethacin DRUG

50 mg / 6 hours during 5 days

indomethacin

placebo DRUG

50 mg / 6 hours during 5 days

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sara Varea: lead

Study Sites (1)

Hospital Clinic of Barcelona- Maternity

Barcelona, Barcelona, 08028, Spain

Location

Related Publications (1)

• 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.

  PMID: 35947046 DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 13, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 21, 2014

Record last verified: 2014-10

Locations

ES (1)