Trial of the Use of Antenatal Corticosteroids in Developing Countries

Preterm Birth Clinical Trial

— ACT  

Official title:

Trial of the Use of Antenatal Corticosteroids in Developing Countries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084096
• Other study ID #: GN ACT Study
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2010
• Last updated: July 29, 2014
• Start date: October 2011
• Est. completion date: April 2014

Study information

• Verified date: July 2014
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

One of the United Nations Millennium Summit goals is to reduce the deaths of children <5 years by two-thirds for 2015 (UN, 2000). Given that 38% of all under-five deaths worldwide occur in the first four weeks of life, the goal seems unattainable unless a significant fraction of the neonatal deaths are prevented (Darmstadt et al., 2005). Thus, the provision of health care during the perinatal period in developing countries is a top priority. Preterm birth is a major cause of neonatal mortality, currently responsible for 28% of the deaths overall. As the contribution of preterm birth to neonatal deaths is well above 50% (MacDorman et al., 2005) in middle and high income countries, it is expected that as low income countries improve their development, the relative importance of this cause will increase. One of the most powerful perinatal interventions to reduce neonatal mortality is the administration of antenatal corticosteroids to pregnant women at high risk of preterm birth.

The primary objective will be to evaluate whether a cluster-level multifaceted intervention, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, reduces neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six African, Asian, and Latin American countries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6214
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

This is an intent-to-treat design and thus all pregnancy outcomes of women who deliver in the study clusters and provide consent will be collected. Cluster-level inclusion criteria include

• At least 250 deliveries per year.

• Birth attendants within the health cluster will be consented to participate

Participant-level inclusion criteria include all pregnant women living in and delivering in the study cluster who:

• Are between 24 and 36 weeks GA;

• Present with signs of preterm labor, amniotic fluid leakage, hemorrhage, or hypertension;

• Provide consent for injection or present to a facility where it is standard of care.

Exclusion Criteria:

• There will not be any specific exclusion criteria for clusters or participants.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

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.

Locations

Country	Name	City	State
Argentina	Institute for Clinical Effectiveness and Health Policy (IECS)	Buenos Aires
Guatemala	Universidad Francisco Marroquin Facultad de Medicina	Guatemala City
India	JN Medical College	Belgaum
India	Lata Medical Research Foundation	Nagpur
Kenya	Moi University School of Medicine	Eldoret
Pakistan	Aga Khan University	Karachi
Zambia	University of Zambia	Lusaka

Sponsors (16)

Lead Sponsor

Collaborator

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

Aga Khan University, Christiana Care Health Services, Columbia University, Indiana University, Institute for Clinical Effectiveness and Health Policy, Jawaharlal Nehru Medical College, Lata Medical Research Foundation, Nagpur, Massachusetts General Hospital, Moi Univeristy, RTI International, Tulane University School of Medicine, Universidad Francisco Marroquín, University of Alabama at Birmingham, University of Colorado, Denver, University Teaching Hospital, Lusaka, Zambia

Countries where clinical trial is conducted

Argentina,  Guatemala,  India,  Kenya,  Pakistan,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal mortality at 28 days in <5th percentile birth weight infants (as a proxy measure for prematurity)		28 days
Secondary	Use of antenatal corticosteroids in women at risk of preterm birth in all the study clusters	Antenatal corticosteroid use will be assessed in LBW newborn infants, defined as the number of live-born babies in predefined birth weight groups whose mothers received at least one 6-mg antenatal dose of dexamethasone for prevention of neonatal complications, per 1000 live-birth babies born in the same birth weight group.	48 hours after identification of risk for preterm birth