Trial of the Use of Antenatal Corticosteroids in Developing Countries (ACT)

This study has been completed.
Sponsor:
Collaborators:
RTI International
Tulane University School of Medicine
Institute for Clinical Effectiveness and Health Policy
University of Alabama at Birmingham
University Teaching Hospital of Lusaka
University of Colorado, Denver
Universidad Francisco Marroquin Facultad de Medicina
Jawaharlal Nehru Medical College
Christiana Care Health Services
Aga Khan University
Columbia University
Indiana University
Moi Univeristy
Lata Medical Research Foundation, Nagpur
Massachusetts General Hospital
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT01084096
First received: March 9, 2010
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Preterm Birth
Behavioral: Increasing use of Antenatal Corticosteroids (ACS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial of the Use of Antenatal Corticosteroids in Developing Countries

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • Neonatal mortality at 28 days in <5th percentile birth weight infants (as a proxy measure for prematurity) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of antenatal corticosteroids in women at risk of preterm birth in all the study clusters [ Time Frame: 48 hours after identification of risk for preterm birth ] [ Designated as safety issue: No ]
    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.


Enrollment: 6214
Study Start Date: October 2011
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention
Eligible women at high risk for preterm birth will be identified and four 6 mg doses of dexamethasone will be administered before delivery.
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.

No Intervention: Control
Control arm will not receive a specific intervention for comparison.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084096

Locations
Argentina
Institute for Clinical Effectiveness and Health Policy (IECS)
Buenos Aires, Argentina
Guatemala
Universidad Francisco Marroquin Facultad de Medicina
Guatemala City, Guatemala
India
JN Medical College
Belgaum, India
Lata Medical Research Foundation
Nagpur, India
Kenya
Moi University School of Medicine
Eldoret, Kenya
Pakistan
Aga Khan University
Karachi, Pakistan
Zambia
University of Zambia
Lusaka, Zambia
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
RTI International
Tulane University School of Medicine
Institute for Clinical Effectiveness and Health Policy
University of Alabama at Birmingham
University Teaching Hospital of Lusaka
University of Colorado, Denver
Universidad Francisco Marroquin Facultad de Medicina
Jawaharlal Nehru Medical College
Christiana Care Health Services
Aga Khan University
Columbia University
Indiana University
Moi Univeristy
Lata Medical Research Foundation, Nagpur
Massachusetts General Hospital
Investigators
Principal Investigator: Fernando Althabe, M.D. Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina
  More Information

No publications provided by NICHD Global Network for Women's and Children's Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT01084096     History of Changes
Other Study ID Numbers: GN ACT Study
Study First Received: March 9, 2010
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
Antenatal Corticosteroids, Preterm Birth, Diffusion

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on October 19, 2014