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

This study is currently recruiting participants.
Verified July 2012 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01084096
First received: March 9, 2010
Last updated: August 30, 2012
Last verified: July 2012

March 9, 2010
August 30, 2012
October 2011
January 2014   (final data collection date for primary outcome measure)
Neonatal mortality at 28 days in low birth weight infants (as a proxy measure for prematurity) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01084096 on ClinicalTrials.gov Archive Site
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 all 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.
Not Provided
Not Provided
Not Provided
 
Trial of the Use of Antenatal Corticosteroids in Developing Countries
Trial of the Use of Antenatal Corticosteroids in Developing Countries

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Preterm Birth
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.

  • 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.
    Intervention: Behavioral: Increasing use of Antenatal Corticosteroids (ACS)
  • No Intervention: Control
    Control arm will not receive a specific intervention for comparison.
Althabe F, Belizán JM, Mazzoni A, Berrueta M, Hemingway-Foday J, Koso-Thomas M, McClure E, Chomba E, Garces A, Goudar S, Kodkany B, Saleem S, Pasha O, Patel A, Esamai F, Carlo WA, Krebs NF, Derman RJ, Goldenberg RL, Hibberd P, Liechty EA, Wright LL, Bergel EF, Jobe AH, Buekens P. Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: study protocol. Reprod Health. 2012 Sep 19;9:22. doi: 10.1186/1742-4755-9-22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6000
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Female
Not Provided
Yes
Contact: Marion Koso-Thomas, MD 301-435-6873 kosomari@mail.nih.gov
Contact: Linda Wright, MD 301-402-0830 wrightl@mail.nih.gov
Argentina,   Guatemala,   India,   Kenya,   Pakistan,   Zambia
 
NCT01084096
GN ACT Study
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • 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
Principal Investigator: Fernando Althabe, M.D. Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP