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:

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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 10, 2012
Last Updated Date	February 15, 2013
Start Date ^ICMJE	April 2012
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 18, 2012)	Gestational age at delivery [ Time Frame: before than 42 weeks of gestation ] [ Designated as safety issue: No ] number of weeks and days at delivery
Original Primary Outcome Measures ^ICMJE (submitted: April 12, 2012)	Gestational age at labor [ Time Frame: before than 42 weeks of gestation ] [ Designated as safety issue: No ] number of weeks and days in the day of labor
Change History	Complete list of historical versions of study NCT01577121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 18, 2012)	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
Original Secondary Outcome Measures ^ICMJE (submitted: April 12, 2012)	proportion of patients with labor before week 34 of gestation [ Time Frame: at the end of study (maximum 1 year) ] [ Designated as safety issue: No ] the participants will be followed until the labor. The proportion of patiens with labor before week 34 would be available at the end of the study; once the last patient woull arrive to labor. Incidence of adverse events [ Time Frame: 1 year (end of study) ] [ Designated as safety issue: Yes ] there will be a registration of adverse events number of days between admission to hospital due to Threatened preterm labor to labor [ Time Frame: between initial admission and labor (before 42 weeks of gestation) ] [ Designated as safety issue: No ] the patients will be recruited during an admission to the hospital due to a threatened of premature labor; investigators will stimate the number of days between that admission and the labor day IL-6 levels in fetal plasma, amniotic liquid and umbilical cord blood [ Time Frame: labor (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 labor (before 42 weeks of gestation) ] [ Designated as safety issue: No ] the investigators will count the number of visits to hospital due to an emergency reason Neonatal morbility [ Time Frame: at the end of the study (1 year) ] [ Designated as safety issue: No ] the investigators will collect after the labor information about neonatal morbility: if an admission is needed, respiratory distress, congenital sepsis,... exitus neonatal [ Time Frame: at the end of the study (1 year) ] [ Designated as safety issue: Yes ] the investigators will register the number of neonatal exitus
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation
Official Title ^ICMJE	Evaluation of the Utility of Indomethacin as Support Treatment in Women With Preterm Labor With Intact Membranes and High Risk of Intraamniotic Inflammation
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Preterm Labor With Intact Membranes
Intervention ^ICMJE	Drug: indomethacin 50 mg / 6 hours during 5 days Drug: placebo 50 mg / 6 hours during 5 days
Study Arm (s)	Placebo Comparator: placebo Intervention: Drug: placebo Experimental: indomethacin 50 mg/ 6 hours of indomethacin oral use Intervention: Drug: indomethacin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	April 2013
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01577121
Other Study ID Numbers ^ICMJE	INDOGEST
Has Data Monitoring Committee	No
Responsible Party	Sara Varea, Fundació Clínic per la Recerca Biomèdica
Study Sponsor ^ICMJE	Sara Varea
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Fundacion Clinic per a la Recerca Biomédica
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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