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

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

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

Study Overview

• Status: Completed
• Conditions: Preterm Labor With Intact Membranes
• Intervention / Treatment: Drug: placebo; Drug: indomethacin

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Hospital Clinic of Barcelona- Maternity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; 50 mg / 6 hours during 5 days
Experimental: indomethacin; 50 mg/ 6 hours of indomethacin oral use	Drug: indomethacin; 50 mg / 6 hours during 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at delivery	number of weeks and days at delivery	before than 42 weeks of gestation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sara Varea

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 10, 2012
• First Submitted That Met QC Criteria: April 12, 2012
• First Posted (Estimate): April 13, 2012

Study Record Updates

• Last Update Posted (Estimate): October 21, 2014
• Last Update Submitted That Met QC Criteria: October 20, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Preterm labor
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Inflammation; Premature Birth; Obstetric Labor, Premature; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Indomethacin
• Other Study ID Numbers: INDOGEST