Understanding metabolism of drug and changes in human functioning for drug given to pregnant women at risk of late preterm birth

Pharmacokinetics and Pharmacodynamics of antenatal corticosteroids when given to woman at risk of late preterm birth - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058248

Enrollment

300

Registered

2023-10-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: Dexamethasone phosphate 4x6mg q12h (Dexa-4x6mg) regimen: A single course of 6mg IM dexamethasone sodium phosphate administered every 12 hours, to a total of four doses (starting immedia

Eligibility

Inclusion criteria

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

Exclusion criteria: ACTION III participants who are diabetic, severely anaemic or with features of HELLP syndrome will be excluded

Design outcomes

Primary

Measure	Time frame
1. Pharmacokinetics (plasma steroid concentration measurement) of betamethasone phosphate and dexamethasone phosphate in pregnant women at risk of late preterm birth 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: 1. Baseline (prior to administration of 1st dose) (PK and PD outcome measurement) 2. 2-4 hrs after 1st dose 3. 8-12 hrs after 1st does 4. 24-36 hrs after last dose 5. At time of birth For PD outcome measurement , 2 additional timepoints: 6. 48-60 hrs after last dose 7. 72-96 hrs after last dose	—

Measure

Time frame

1. Pharmacokinetics (plasma steroid concentration measurement) of betamethasone phosphate and dexamethasone phosphate in pregnant women at risk of late preterm birth 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: 1. Baseline (prior to administration of 1st dose) (PK and PD outcome measurement) 2. 2-4 hrs after 1st dose 3. 8-12 hrs after 1st does 4. 24-36 hrs after last dose 5. At time of birth For PD outcome measurement , 2 additional timepoints: 6. 48-60 hrs after last dose 7. 72-96 hrs after last dose

—

Secondary

Measure	Time frame
1. Dexamethasone phosphate & Betamethasone phosphate measurement in cord blood ; feto-maternal ratio of Dexamethasone phosphate & Betamethasone phosphate 2. Pharmacodynamics (serum cortisol, glucose & white cell counts measurement) in cord blood of betamethasone phosphate & dexamethasone phosphate treated womenTimepoint: At the time of birth	—

Countries

India, Nigeria

Contacts

Public ContactDr Shivaprasad S Goudar

KLE Academy of Higher Education and Researchs J N Medical College

sgoudar@jnmc.edu9448126371

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026