Evaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation (INDOGEST)
This study is currently recruiting participants.
Verified February 2013 by Fundacion Clinic per a la Recerca Biomédica
Sponsor:
Sara Varea
Information provided by (Responsible Party):
Sara Varea, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01577121
First received: April 10, 2012
Last updated: February 15, 2013
Last verified: February 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Preterm Labor With Intact Membranes |
Drug: indomethacin Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of the Utility of Indomethacin as Support Treatment in Women With Preterm Labor With Intact Membranes and High Risk of Intraamniotic Inflammation |
Resource links provided by NLM:
Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:
Primary Outcome Measures:
- Gestational age at delivery [ Time Frame: before than 42 weeks of gestation ] [ Designated as safety issue: No ]number of weeks and days at delivery
Secondary Outcome Measures:
- proportion of patients with spontaneous preterm delivery before 34 weeks of gestation [ Time Frame: at the end of study (maximum 1 year) ] [ Designated as safety issue: No ]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.
- Incidence of adverse events [ Time Frame: 1 year (end of study) ] [ Designated as safety issue: Yes ]adverse events will be registered
- Latency from admission to delivery [ Time Frame: between initial admission and delivery (before 42 weeks of gestation) ] [ Designated as safety issue: No ]Latency from admission to delivery will be calculated
- IL-6 levels in amniotic fluid and umbilical cord blood [ Time Frame: delivery (maximum 42 weeks of gestational age) ] [ Designated as safety issue: No ]the investigators will determine the level of IL-6 in different samples
- Number of emergency visits [ Time Frame: between initial admission and delivery (before 42 weeks of gestation) ] [ Designated as safety issue: No ]Number of visits to emergency area will be registered
- Neonatal morbidity [ Time Frame: at the end of the study (1 year) ] [ Designated as safety issue: No ]
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.
- Neonatal death [ Time Frame: at the end of the study (1 year) ] [ Designated as safety issue: Yes ]Neonatal deaths will be registered
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577121
Locations
| Spain | |
| Hospital Clinic of Barcelona- Maternity | Recruiting |
| Barcelona, Spain, 08028 | |
| Contact: Montse Palacio, MD +34932275400 mpalacio@clinic.ub.es | |
| Contact: Teresa Cobo, MD +34932275400 tcobo@clinic.ub.es | |
| Principal Investigator: Montse Palacio, MD | |
Sponsors and Collaborators
Sara Varea
More Information
No publications provided
| Responsible Party: | Sara Varea, Clinical Research Manager, Fundació Clínic per la Recerca Biomèdica |
| ClinicalTrials.gov Identifier: | NCT01577121 History of Changes |
| Other Study ID Numbers: | INDOGEST |
| Study First Received: | April 10, 2012 |
| Last Updated: | February 15, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Fundacion Clinic per a la Recerca Biomédica:
|
Preterm labor |
Additional relevant MeSH terms:
|
Inflammation Obstetric Labor, Premature Pathologic Processes Obstetric Labor Complications Pregnancy Complications Indomethacin Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Tocolytic Agents Reproductive Control Agents |
Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Cardiovascular Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013