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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
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
  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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ]

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 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.


Estimated Enrollment: 6000
Study Start Date: October 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 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

Contacts
Contact: Marion Koso-Thomas, MD 301-435-6873 kosomari@mail.nih.gov
Contact: Linda Wright, MD 301-402-0830 wrightl@mail.nih.gov

Locations
Argentina
Institute for Clinical Effectiveness and Health Policy (IECS) Recruiting
Buenos Aires, Argentina
Contact: Fernando Althabe, MD    +5411 47778767 ext 17    althabef@gmail.com   
Contact: Jose Belizan, MD    +5411 47778767 ext 17    belizanj@gmail.com   
Guatemala
Universidad Francisco Marroquin Facultad de Medicina Recruiting
Guatemala City, Guatemala
Contact: Ana Garces, MD    +502-2332-4064    anagarces@imsalud.org   
India
JN Medical College Recruiting
Belgaum, India
Contact: Bhala Kodkany, MD    +91 831 2409 2051    drkodkany@jnmc.edu   
Lata Medical Research Foundation Recruiting
Nagpur, India
Contact: Archana Patel, MD    91-98 2315 4463    dr_apatel@yahoo.com   
Kenya
Moi University School of Medicine Recruiting
Eldoret, Kenya
Contact: Fabian Esamai, MD    (254) 733 836 410    fesamai2007@gmail.com   
Pakistan
Aga Khan University Recruiting
Karachi, Pakistan
Contact: Omrana Pasha, MD    (92-21) 3486-4948    omrana.pasha@aku.edu   
Zambia
University of Zambia Recruiting
Lusaka, Zambia
Contact: Elwyn Chomba, MD    +260211 254655    echomba@zamnet.zm   
Sponsors and 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
Investigators
Principal Investigator: Fernando Althabe, M.D. Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina
  More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01084096     History of Changes
Other Study ID Numbers: GN ACT Study
Study First Received: March 9, 2010
Last Updated: August 30, 2012
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
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 July 23, 2014