Trial of the Use of Antenatal Corticosteroids in Developing Countries

NCT01084096 | Completed Results DMC

• 1 other identifier: GN ACT Study
• Study Type: interventional
• Target: 103,117
• Locations: 6 countries
• Sites: 7

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.

Conditions

Preterm Birth

Keywords

Antenatal Corticosteroids, Preterm Birth, Diffusion

Outcome Measures

Primary Outcomes (1)

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

  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.

  Birth to 28 days

Secondary Outcomes (5)

• 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

• Suspected Maternal Infection

  Pregnancy through 6 weeks postpartum

• Maternal Mortality Rate

  Pregnancy through 42 days postpartum

• Neonatal Mortality Rate

  Birth to 28 days

• Stillbirth Mortality Rate

  20 weeks' gestational age to birth

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

NO INTERVENTION

Control arm will not receive a specific intervention for comparison.

Interventions

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.

Also known as: Four 6 mg doses of dexamethasone

Intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 250 deliveries per year.
• Birth attendants within the health cluster will be consented to participate
• 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.

Sponsors & Collaborators

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

Study Sites (7)

Institute for Clinical Effectiveness and Health Policy (IECS)

Buenos Aires, Argentina

Location

Universidad Francisco Marroquin Facultad de Medicina

Guatemala City, Guatemala

Location

JN Medical College

Belagavi, India

Location

Lata Medical Research Foundation

Nagpur, India

Location

Moi University School of Medicine

Eldoret, Kenya

Location

Aga Khan University

Karachi, Pakistan

Location

University of Zambia

Lusaka, Zambia

Location

Related Publications (9)

• McGoldrick E, Stewart F, Parker R, Dalziel SR. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2020 Dec 25;12(12):CD004454. doi: 10.1002/14651858.CD004454.pub4.

  PMID: 33368142 DERIVED

• Rohwer AC, Oladapo OT, Hofmeyr GJ. Strategies for optimising antenatal corticosteroid administration for women with anticipated preterm birth. Cochrane Database Syst Rev. 2020 May 26;5(5):CD013633. doi: 10.1002/14651858.CD013633.

  PMID: 32452555 DERIVED

• Patel A, Prakash AA, Pusdekar YV, Kulkarni H, Hibberd P. Detection and risk stratification of women at high risk of preterm birth in rural communities near Nagpur, India. BMC Pregnancy Childbirth. 2017 Sep 19;17(1):311. doi: 10.1186/s12884-017-1504-4.

  PMID: 28927395 DERIVED

• Goldenberg RL, Thorsten VR, Althabe F, Saleem S, Garces A, Carlo WA, Pasha O, Chomba E, Goudar S, Esamai F, Krebs NF, Derman RJ, Liechty EA, Patel A, Hibberd PL, Buekens PM, Koso-Thomas M, Miodovnik M, Jobe AH, Wallace DD, Belizan JM, McClure EM. The global network antenatal corticosteroids trial: impact on stillbirth. Reprod Health. 2016 Jun 2;13(1):68. doi: 10.1186/s12978-016-0174-4.

  PMID: 27255082 DERIVED

• Berrueta M, Hemingway-Foday J, Thorsten VR, Goldenberg RL, Carlo WA, Garces A, Patel A, Saleem S, Pasha O, Chomba E, Hibberd PL, Krebs NF, Goudar S, Derman RJ, Esamai F, Liechty EA, Moore JL, McClure EM, Koso-Thomas M, Buekens PM, Belizan JM, Althabe F. Use of antenatal corticosteroids at health facilities and communities in low-and-middle income countries. Reprod Health. 2016 May 27;13(1):66. doi: 10.1186/s12978-016-0176-2.

  PMID: 27228986 DERIVED

• Klein K, McClure EM, Colaci D, Thorsten V, Hibberd PL, Esamai F, Garces A, Patel A, Saleem S, Pasha O, Chomba E, Carlo WA, Krebs NF, Goudar S, Derman RJ, Liechty EA, Koso-Thomas M, Buekens PM, Belizan JM, Goldenberg RL, Althabe F. The Antenatal Corticosteroids Trial (ACT): a secondary analysis to explore site differences in a multi-country trial. Reprod Health. 2016 May 24;13(1):64. doi: 10.1186/s12978-016-0179-z.

  PMID: 27221319 DERIVED

• Garces A, McClure EM, Figueroa L, Pineda S, Hambidge KM, Krebs NF, Thorsten VR, Wallace DD, Althabe F, Goldenberg RL. A multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth: a case study from the Guatemalan Western Highlands. Reprod Health. 2016 May 24;13(1):63. doi: 10.1186/s12978-016-0178-0.

  PMID: 27221237 DERIVED

• Althabe F, Belizan JM, McClure EM, Hemingway-Foday J, Berrueta M, Mazzoni A, Ciganda A, Goudar SS, Kodkany BS, Mahantshetti NS, Dhaded SM, Katageri GM, Metgud MC, Joshi AM, Bellad MB, Honnungar NV, Derman RJ, Saleem S, Pasha O, Ali S, Hasnain F, Goldenberg RL, Esamai F, Nyongesa P, Ayunga S, Liechty EA, Garces AL, Figueroa L, Hambidge KM, Krebs NF, Patel A, Bhandarkar A, Waikar M, Hibberd PL, Chomba E, Carlo WA, Mwiche A, Chiwila M, Manasyan A, Pineda S, Meleth S, Thorsten V, Stolka K, Wallace DD, Koso-Thomas M, Jobe AH, Buekens PM. A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: the ACT cluster-randomised trial. Lancet. 2015 Feb 14;385(9968):629-639. doi: 10.1016/S0140-6736(14)61651-2. Epub 2014 Oct 15.

  PMID: 25458726 DERIVED

• Althabe F, Belizan JM, Mazzoni A, Berrueta M, Hemingway-Foday J, Koso-Thomas M, McClure E, Chomba E, Garces A, Goudar S, Kodkany B, Saleem S, Pasha O, Patel A, Esamai F, Carlo WA, Krebs NF, Derman RJ, Goldenberg RL, Hibberd P, Liechty EA, Wright LL, Bergel EF, Jobe AH, Buekens P. Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: study protocol. Reprod Health. 2012 Sep 19;9:22. doi: 10.1186/1742-4755-9-22.

  PMID: 22992312 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr. Elizabeth McClure, Data Coordinating Center PI
• Organization: NICHDGlobal

mcclure@rti.org

919-316-3773

Study Officials

• Fernando Althabe, M.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Study Start: October 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-10

Locations

AR (1); GU (1); KE (1); IN (2); ZA (1); PA (1)