Trial of the Use of Antenatal Corticosteroids in Developing Countries

Not Applicable

Completed

Interventions: Behavioral: Increasing use of Antenatal Corticosteroids (ACS)

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Intervention	Increasing use of Antenatal Corticosteroids (ACS)	Eligible women at high risk for preterm birth will be identified and four 6 mg doses of dexamethasone will be administered before delivery.

Primary Outcome Measures

Name	Time	Method
Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity)	Birth to 28 days	Neonatal deaths before 28 days per 1,000 live births among \<5th %tile birth weight infants. The \<5th %tile birth weight group was a proxy for preterm. Site-specific cutoffs from pretrial data were 2,450g-Argentina, 2,400g-Zambia, 2,267g-Guatemala, 2,000g-Belgaum, India, 2,150g-Pakistan, 2,000g-Nagpur, India, and 2,500g-Kenya. Infants were classified as \<5th %tile on the basis of measured birth weights. Estimated weights by clinical assessment were used when measured weights were unavailable; those missing weights were classified as \<5th %tile (since based on historical data, most of the missing data were for preterm infants). We used birth weight rather than gestational age (GA) for the primary analysis subgroup because many women in the registry had missing or uncertain GA, ultrasound was often unavailable, and the intervention was designed to improve estimation of GA, which could potentially bias GA-based analyses. All live births, including multiple births, are included.

Secondary Outcome Measures

Name	Time	Method
Use of Antenatal Corticosteroids in Women at Risk of Preterm Birth in All the Study Clusters	48 hours after identification of risk for preterm birth	Antenatal corticosteroids provided antepartum assessed in women with a less-than-5th-percentile for birth weight infants. Site-specific cut offs were determined from pretrial data.
Suspected Maternal Infection	Pregnancy through 6 weeks postpartum	Maternal safety was assessed through the frequency of suspected maternal infection, a composite of process outcomes including receipt of antibiotics plus hospital admission or referral, and receipt of intravenous fluids, surgery, or other treatment related to infection. The definition also included evidence of antepartum or post-partum infection for mothers with infants with a birthweight less than 2500 g. Additionally, use of antenatal corticosteroids, neonatal and perinatal mortality, and suspected maternal infection were measured for all births, irrespective of birthweight.
Maternal Mortality Rate	Pregnancy through 42 days postpartum	The denominator for maternal deaths through 42 days is pregnancy ending in live birth + all maternal deaths. Maternal mortality includes all maternal deaths through 42 days postpartum, irrespective of cause.
Neonatal Mortality Rate	Birth to 28 days	Number of neonatal deaths before 28 days per 1,000 live births
Stillbirth Mortality Rate	20 weeks' gestational age to birth	Number of stillbirths per 1,000 births

Locations (7): JN Medical College
🇮🇳
Belgaum, India
Institute for Clinical Effectiveness and Health Policy (IECS)
🇦🇷
Buenos Aires, Argentina
Lata Medical Research Foundation
🇮🇳
Nagpur, India
Aga Khan University
🇵🇰
Karachi, Pakistan
Universidad Francisco Marroquin Facultad de Medicina
🇬🇹
Guatemala City, Guatemala
Moi University School of Medicine
🇰🇪
Eldoret, Kenya
University of Zambia
🇿🇲
Lusaka, Zambia