Back to resultsEvaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation (INDOGEST)
Primary Purpose
Preterm Labor With Intact Membranes
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
indomethacin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Labor With Intact Membranes focused on measuring Preterm labor
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
Sites / Locations
- Hospital Clinic of Barcelona- Maternity
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
indomethacin
Arm Description
50 mg/ 6 hours of indomethacin oral use
Outcomes
Primary Outcome Measures
Gestational age at delivery
number of weeks and days at delivery
Secondary Outcome Measures
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.
Incidence of adverse events
adverse events will be registered
Latency from admission to delivery
Latency from admission to delivery will be calculated
IL-6 levels in amniotic fluid and umbilical cord blood
the investigators will determine the level of IL-6 in different samples
Number of emergency visits
Number of visits to emergency area will be registered
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.
Neonatal death
Neonatal deaths will be registered
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01577121
Brief Title
Evaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation
Acronym
INDOGEST
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Varea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor With Intact Membranes
Keywords
Preterm labor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
indomethacin
Arm Type
Experimental
Arm Description
50 mg/ 6 hours of indomethacin oral use
Intervention Type
Drug
Intervention Name(s)
indomethacin
Intervention Description
50 mg / 6 hours during 5 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
50 mg / 6 hours during 5 days
Primary Outcome Measure Information:
Title
Gestational age at delivery
Description
number of weeks and days at delivery
Time Frame
before than 42 weeks of gestation
Secondary Outcome Measure Information:
Title
proportion of patients with spontaneous preterm delivery before 34 weeks of gestation
Description
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.
Time Frame
at the end of study (maximum 1 year)
Title
Incidence of adverse events
Description
adverse events will be registered
Time Frame
1 year (end of study)
Title
Latency from admission to delivery
Description
Latency from admission to delivery will be calculated
Time Frame
between initial admission and delivery (before 42 weeks of gestation)
Title
IL-6 levels in amniotic fluid and umbilical cord blood
Description
the investigators will determine the level of IL-6 in different samples
Time Frame
delivery (maximum 42 weeks of gestational age)
Title
Number of emergency visits
Description
Number of visits to emergency area will be registered
Time Frame
between initial admission and delivery (before 42 weeks of gestation)
Title
Neonatal morbidity
Description
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.
Time Frame
at the end of the study (1 year)
Title
Neonatal death
Description
Neonatal deaths will be registered
Time Frame
at the end of the study (1 year)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Clinic of Barcelona- Maternity
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
35947046
Citation
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.
Results Reference
derived
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Evaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation
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