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Completed

NCT Number: NCT01084096

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.

Completed

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Increasing use of Antenatal Corticosteroids (ACS)

Behavioral

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.

Other names: Four 6 mg doses of dexamethasone

Primary outcomes

  1. Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity)

    Time frame: 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 outcomes

  1. 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 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.

  2. Suspected Maternal Infection

    Time frame: 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.

  3. Maternal Mortality Rate

    Time frame: 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.

  4. Neonatal Mortality Rate

    Time frame: Birth to 28 days

    Number of neonatal deaths before 28 days per 1,000 live births

  5. Stillbirth Mortality Rate

    Time frame: 20 weeks' gestational age to birth

    Number of stillbirths per 1,000 births

Sponsors and collaborators

Lead sponsor

NICHD Global Network for Women's and Children's Health

Network

Collaborators

  • Aga Khan University
  • Christiana Care Health Services
  • Columbia University
  • Indiana University
  • Institute for Clinical Effectiveness and Health Policy
  • Jawaharlal Nehru Medical College
  • Lata Medical Research Foundation, Nagpur
  • Massachusetts General Hospital
  • Moi Univeristy
  • RTI International
  • Tulane University School of Medicine
  • Universidad Francisco Marroquín
  • University Teaching Hospital, Lusaka, Zambia
  • University of Alabama at Birmingham
  • University of Colorado, Denver

Registry information

Acronym: ACT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 10, 2010
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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