nderstanding metabolism of drug and changes in human functioning for drug given to pregnant women at risk of late preterm birth
Phase 3
- Conditions
- Health Condition 1: P220- Respiratory distress syndrome of newborn
- Registration Number
- CTRI/2023/10/058248
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Consecutive women enrolled into the ACTION III trial at the two Indian sites, KLE Academy of Higher Education and Research and VMMC & Safdarjung hospital will be approached over a period of 4 months.
Exclusion Criteria
ACTION III participants who are diabetic, severely anaemic or with features of HELLP syndrome will be excluded
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Pharmacokinetics (plasma steroid concentration measurement) of betamethasone phosphate and dexamethasone phosphate in pregnant women at risk of late preterm birth <br/ ><br>2. Pharmacodynamics (serum cortisol, glucose and white cell counts measurement) in betamethasone phosphate and dexamethasone phosphate treated pregnant women at risk of late preterm birthTimepoint: For PK and PD outcome measurement: <br/ ><br>1. Baseline (prior to administration of 1st dose) (PK and PD outcome measurement) <br/ ><br>2. 2-4 hrs after 1st dose <br/ ><br>3. 8-12 hrs after 1st does <br/ ><br>4. 24-36 hrs after last dose <br/ ><br>5. At time of birth <br/ ><br> <br/ ><br>For PD outcome measurement , 2 additional timepoints: <br/ ><br>6. 48-60 hrs after last dose <br/ ><br>7. 72-96 hrs after last dose
- Secondary Outcome Measures
Name Time Method 1. Dexamethasone phosphate & Betamethasone phosphate measurement in cord blood ; feto-maternal ratio of Dexamethasone phosphate & Betamethasone phosphate <br/ ><br>2. Pharmacodynamics (serum cortisol, glucose & white cell counts measurement) in cord blood of betamethasone phosphate & dexamethasone phosphate treated womenTimepoint: At the time of birth