Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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CTRI |
Last refreshed on:
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24 November 2021 |
Main ID: |
CTRI/2017/05/008721 |
Date of registration:
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31-05-2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Improving newborn survival in late preterm birth
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Scientific title:
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A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the late preterm period in hospitals in low-resource countries to improve newborn outcomes - Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns (ACTION-II TRIAL) |
Date of first enrolment:
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01-07-2017 |
Target sample size:
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22589 |
Recruitment status: |
Completed |
URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18977 |
Study type:
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Interventional |
Study design:
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Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
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Phase:
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Phase 3
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Countries of recruitment
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Bangladesh
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India
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Kenya
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Nigeria
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Pakistan
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Contacts
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Name:
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Dr Shivaprasad S Goudar
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Address:
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KLE Universitys J N Medical College Nehru Nagar Belgaum Research Coordinator Womens and Childrens Health Research Unit Wing
590010
Belgaum, KARNATAKA
India |
Telephone:
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9448126371 |
Email:
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sgoudar@jnmc.edu |
Affiliation:
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KLE Univeristys J N Medical College |
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Name:
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Dr Shivaprasad S Goudar
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Address:
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KLE Universitys J N Medical College Nehru Nagar Belgaum Research Coordinator Womens and Childrens Health Research Unit Wing
590010
Belgaum, KARNATAKA
India |
Telephone:
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9448126371 |
Email:
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sgoudar@jnmc.edu |
Affiliation:
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KLE Univeristys J N Medical College |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1 Birth planned or expected within 48 hours
2 Gestational age from 34 weeks 0 days to 36 weeks 0 days
3 Women with singleton or multiple pregnancies, where the fetus(es) is(are) alive
4 Women with no clinical signs of severe infection (as per clinical assessment)
5 Women willing and able to provide consent
Women with the following conditions are eligible. Any comorbid conditions will be managed according to local guidelines, and in line with WHO recommendations:
6 Women with a history of previous preterm birth
7 Women with hypertensive disorders
8 Women with a growth impaired fetus
9 Women with pre-gestational or gestational diabetes
10 Women with HIV/AIDs
Exclusion criteria: 1 Intrauterine fetal death
2 Major or lethal congenital fetal anomaly identified
3 Clinical suspicion or evidence of clinical chorioamnionitis, as per obstetric care physician assessment
4 Clinical suspicion or evidence of severe infection, as per obstetric care physician assessment
5 No prior ultrasound-based estimate of gestational age available and immediate ultrasound examination is not possible
6 Any concurrent or recent (within the past 2 weeks) systemic corticosteroid use during the current pregnancy (outside of trial)
7 Unwilling or unable to provide consent
Currently a participant in another clinical trial related to maternal and neonatal health
8 Any other clinical indication where the treating clinician considers corticosteroids to be contraindicated
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Prevention of neonatal deaths by administration of Antenatal Corticosteroids to women with a live fetus/es at risk of imminent preterm birth from 34 weeks 0 days to 35 weeks 6 days gestation
Health Condition 2: P220- Respiratory distress syndrome of newborn
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Intervention(s)
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Intervention1: Dexamethasone: Dose- 6 mg Route of administration- Intramuscular(IM) Frequency and TOTAL duration of therapy-single course-administered every 12 hours, to a total of four (4) doses (time points 0 hours, 12 hours, 24 hours and 36 hours)
Control Intervention1: Identical placebo: Dose- 6 mg Route of administration- Intramuscular(IM) Frequency and TOTAL duration of therapy-single course-administered every 12 hours, to a total of four (4) doses (time points 0 hours, 12 hours, 24 hours and 36 hours)
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Primary Outcome(s)
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1 Any baby death
a.Neonatal death (death of a liveborn within 28 completed days of life)
b. Stillbirth or neonatal death (any death of a fetus (post enrollment), or death of a live birth within 28 completed days of life among all enrolled participants.
2 Severe respiratory distress of the neonate
3 Possible maternal bacterial infection (occurrence of maternal fever, or clinically suspected or confirmed infection, for which therapeutic antibiotics were used)Timepoint: Randomization to 28 days postpartum
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Secondary Outcome(s)
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Process of care outcomes
Neonate:
1. Measures of care given to neonate
Major neonatal resuscitation at birth
Timing of breast milk feeding initiation
Time to full enteral feeding
Use and length of oxygen therapy
Use and length of continuous positive airway pressure (CPAP) ventilation
Use and length of mechanical ventilation (MV)
Use and length of parenteral antibiotic therapy
Use and doses of surfactant treatmentTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only)
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Maternal fever â?¥38.0 C after enrolment (on any one occasion during hospital admission)Timepoint: Randomization to 28 days postpartum
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ChorioamnionitisTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only)
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Non-obstetric infection (excluding malaria)Timepoint: Randomization to 28 days postpartum (during postpartum admission/s only)
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Process of care outcomes
Mother:
2. Health service utilization
Mean length of total maternal hospitalization for delivery (days)
Any postpartum maternal readmission to facility (within 28 completed days of delivery)
Number of maternal readmissions to facility
Cause of maternal readmission to facility
Any referral of woman to another facility for treatment of complicationsTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only)
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Early neonatal deathTimepoint: birth to 7 completed days of life
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Maternal death (from time of enrolment to 28 completed days)Timepoint: randomization to 28 days postpartum
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3. Compliance / other study measures
Compliance with study allocation
Total number of ACS doses received1
Time from randomization to birth (days)
Time from initiation of first dose (ACS or placebo) to birth (days)
Gestational age at birthTimepoint: Randomization until birth
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Apgar score at 5 minutesTimepoint: first 5 minutes of life
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Neonatal hypoglycaemiaTimepoint: birth to 28 days of life (during initial postnatal hospitalization only)
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Severe intraventricular haemorrhage (sIVH)Timepoint: birth, up to 7 days of life or discharge
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StillbirthTimepoint: randomization to birth
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Postpartum endometritisTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only)
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Process of care outcomes
2.Health service utilization
Length of hospital stay after birth
Admission to a special care unit
Length of admission to special care unit (days)
Readmission for health care at the facility
Length of readmission (days)
Number of readmissions to health facility
Cause of readmission to health facilityTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only)
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Process of care outcomes
Mother:
1. Measure of care given to woman:
Therapeutic antibiotics for suspected or confirmed infection (obstetric or non-obstetric)
Number of days of therapeutic antibiotic use
Any antibiotic use (prophylactic or therapeutic)Timepoint: Randomization to 28 days postpartum (during postpartum admission/s only)
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Wound infectionTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only)
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Secondary ID(s)
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A65916 version 1.4, 27 March 2017
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Source(s) of Monetary Support
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World Health Organization Department of Reproductive Health and Research 20 Avenue Appia CH 1211 Geneva 27 Switzerland
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Ethics review
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Status: Approved
Approval date: 26/05/2017
Contact:
JNMC Institutional Ethics Committee on Human Subjects Research KLESs Jawaharlal Nehru Medical College Belgaum
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Status: Approved
Approval date: 30/05/2017
Contact:
Institutional Ethical Committee BLDE Universitys Shri B M Patil Medical College
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Status: Approved
Approval date: 30/05/2017
Contact:
Institutional Ethics Committee of S Nijalingappa Medical College and Hanagal Shri Kumareshwar Hospital and Research Centre Bagalkot
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Status: Approved
Approval date: 24/04/2018
Contact:
Institutional Ethics Committee SCB Medical College Cuttack
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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