Trial of the Use of Antenatal Corticosteroids in Developing Countries

Study Overview
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Brief Summary
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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
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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.

Official Title
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Trial of the Use of Antenatal Corticosteroids in Developing Countries

Conditions
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Preterm Birth

Intervention / Treatment
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* Behavioral: Increasing use of Antenatal Corticosteroids (ACS)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>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)<br>* 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.<br>|
| No Intervention: Control<br>Control arm will not receive a specific intervention for comparison. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal mortality at 28 days in <5th percentile birth weight infants (as a proxy measure for prematurity) |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of antenatal corticosteroids in women at risk of preterm birth in all the study clusters | 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. | 48 hours after identification of risk for preterm birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antenatal Corticosteroids, Preterm Birth, Diffusion