Antenatal corticosteroids and small/sick newborn care interventions to Improve preterm birth outcomes in Bangladesh, Pakistan, Ethiopia and Nigeria

Scaling up safe use of antenatal corticosteroids and small/sick newborn care interventions to improve preterm birth outcomes in Bangladesh, Pakistan, Ethiopia and Nigeria - a parallel with baseline cluster randomised trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15483467

Enrollment

500000

Registered

2026-03-06

Start date

2025-12-07

Completion date

Unknown

Last updated

2026-03-16

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

Conditions

Preterm birth Pregnancy and Childbirth

Interventions

Intervention arm ACS & Co-Interventions Antenatal corticosteroids (ACS) for preterm birth, tocolysis & magnesium sulphate for neuroprotection. Intervention includes training on: Right Woman: Identifi

Eligibility

Sex/Gender

All

Age

0 Days to 55 Years

Inclusion criteria

Inclusion criteria: All women and her newborn(s) that are delivered within the network of health facilities

Exclusion criteria

Exclusion criteria: A woman who does not consent to routine clinical data sharing or a neonatal and maternal follow-up on day 28 of life.

Design outcomes

Primary

Measure	Time frame
Any baby death (stillbirth or neonatal death) among babies born =28 to <37 weeks gestation by earliest available ultrasound, else in the absence of an ultrasound birthweight =1000g - =2000g measured using Assessment of mortality by a) Clinician in-hospital or b) mothers report at 28 days of life from birth to 28 days	—

Secondary

Measure	Time frame
1. Preterm neonatal mortality is measured using clinician assessment in-hospital and maternal report at 28-day follow-up from birth to day 28 of life 2. Preterm stillbirth rate is measured using clinician assessment of birth status at the time of birth 3. Any baby death (early preterm) is measured using clinician assessment in-hospital and maternal report at 28-day follow-up from birth to day 28 of life 4. Early preterm neonatal mortality is measured using clinician assessment in-hospital and maternal report at 28-day follow-up from birth to day 28 of life 5. Any baby death is measured using clinician assessment in-hospital and maternal report at 28-day follow-up from birth to day 28 of life 6. Neonatal mortality rate is measured using clinician assessment in-hospital and maternal report at 28-day follow-up from birth to day 28 of life 7. Stillbirth rate is measured using clinician assessment of birth status at the time of birth	—

Measure

Time frame

1. Preterm neonatal mortality is measured using clinician assessment in-hospital and maternal report at 28-day follow-up from birth to day 28 of life 2. Preterm stillbirth rate is measured using clinician assessment of birth status at the time of birth 3. Any baby death (early preterm) is measured using clinician assessment in-hospital and maternal report at 28-day follow-up from birth to day 28 of life 4. Early preterm neonatal mortality is measured using clinician assessment in-hospital and maternal report at 28-day follow-up from birth to day 28 of life 5. Any baby death is measured using clinician assessment in-hospital and maternal report at 28-day follow-up from birth to day 28 of life 6. Neonatal mortality rate is measured using clinician assessment in-hospital and maternal report at 28-day follow-up from birth to day 28 of life 7. Stillbirth rate is measured using clinician assessment of birth status at the time of birth

—

Countries

Bangladesh, Ethiopia, Nigeria, Pakistan

Contacts

Public ContactAyesha De Costa

deay@who.int+41 22 791 21 11

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026