Trial of the Use of Antenatal Corticosteroids in Developing Countries (ACT)
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|ClinicalTrials.gov Identifier: NCT01084096|
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : July 31, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth||Behavioral: Increasing use of Antenatal Corticosteroids (ACS)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial of the Use of Antenatal Corticosteroids in Developing Countries|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||April 2014|
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)
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.
- Neonatal mortality at 28 days in <5th percentile birth weight infants (as a proxy measure for prematurity) [ Time Frame: 28 days ]
- 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 ]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.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
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.
- There will not be any specific exclusion criteria for clusters or participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084096
|Institute for Clinical Effectiveness and Health Policy (IECS)|
|Buenos Aires, Argentina|
|Universidad Francisco Marroquin Facultad de Medicina|
|Guatemala City, Guatemala|
|JN Medical College|
|Lata Medical Research Foundation|
|Moi University School of Medicine|
|Aga Khan University|
|University of Zambia|
|Principal Investigator:||Fernando Althabe, M.D.||Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina|
|Responsible Party:||NICHD Global Network for Women's and Children's Health|
|Other Study ID Numbers:||
GN ACT Study
|First Posted:||March 10, 2010 Key Record Dates|
|Last Update Posted:||July 31, 2014|
|Last Verified:||July 2014|
Antenatal Corticosteroids, Preterm Birth, Diffusion
Obstetric Labor, Premature
Obstetric Labor Complications
Female Urogenital Diseases and Pregnancy Complications