Trial of the Use of Antenatal Corticosteroids in Developing Countries

Summary

Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.

Conditions

• Preterm Birth

Interventions

BEHAVIORAL

Increasing use of Antenatal Corticosteroids (ACS)

Intervention clusters: * Increasing administration of ACS to pregnant women at high risk of preterm birth (HRPB) by providing health providers with kits containing dexamethasone, syringes, and instructions. Eligible women receive four injections of 6 mg dexamethasone from the kit or regimen of choice at the site. * Improving identification of women at HRPB by diffusing recommendations for ACS use to health care providers, training health care providers to identify signs of preterm labor and eligibility criteria for ACS use, providing reminders to healthcare providers on the use of the kits, and using a color-coded tape to measure uterine height to estimate gestational age in women at HRPB with unknown gestational age. Control clusters: no specific intervention for comparison. Both intervention and control clusters: Birth attendants trained in essential newborn care of LBW infants and instructed to teach mothers how to provide care to premature infants.

Sponsors & Collaborators

• RTI International

  collaborator OTHER

• Tulane University School of Medicine

  collaborator OTHER

• Institute for Clinical Effectiveness and Health Policy

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University Teaching Hospital, Lusaka, Zambia

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Universidad Francisco Marroquín

  collaborator OTHER

• Jawaharlal Nehru Medical College

  collaborator OTHER

• Christiana Care Health Services

  collaborator OTHER

• Aga Khan University

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Moi Univeristy

  collaborator OTHER

• Lata Medical Research Foundation, Nagpur

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• NICHD Global Network for Women's and Children's Health

  lead NETWORK

Principal Investigators

• Fernando Althabe, M.D. · Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2014-03-31

Completion

2014-04-30

Countries

• Argentina
• Guatemala
• India
• Kenya
• Pakistan
• Zambia

Study Locations