The global network antenatal corticosteroids trial

Impact on stillbirth

Robert L. Goldenberg, Vanessa R. Thorsten, Fernando Althabe, Sarah Saleem, Ana Garces, Waldemar A. Carlo, Omrana Pasha, Elwyn Chomba, Shivaprasad Goudar, Fabian Esamai, Nancy F. Krebs, Richard J. Derman, Edward A. Liechty, Archana Patel, Patricia L. Hibberd, Pierre M. Buekens, Marion Koso-Thomas, Menachem Miodovnik, Alan H. Jobe, Dennis D. Wallace & 2 others José M. Belizán, Elizabeth M. McClure

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Antenatal corticosteroids are commonly used to reduce neonatal mortality, but most research to date has been in high-resource settings and few studies have evaluated its impact on stillbirth. In the Antenatal Corticosteroids Trial (ACT), a multi-country trial to assess impact of a multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth, we found an overall increase in 28-day neonatal mortality and stillbirth associated with the intervention. Methods: The ACT was a cluster-randomized trial conducted in 102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk. Because of inadequate gestational age dating, the <5th percentile birth weight was used as a proxy for preterm birth. A pre-specified secondary outcome of the trial was stillbirth. Results: After adjusting for the pre-trial imbalance in stillbirth rates, the ACT intervention was associated with a non-significant increased risk of stillbirth (aRR 1.08, 95 % CI, 0.99-1.17, p-0.073). Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters. Differences in obstetric care favored the control clusters and maternal infection was likely more common in the intervention clusters. Conclusions: In this pragmatic trial, limited data were available to identify the causes of the increase in stillbirths in the intervention clusters. A higher rate of stillbirth in the intervention clusters prior to the trial, differences in obstetric care and an increase in maternal infection are potential explanations for the observed increase in stillbirths in the intervention clusters during the trial. Trial registration: clinicaltrials.gov (NCT01084096)

Original languageEnglish (US)
Article number68
JournalReproductive Health
Volume13
Issue number1
DOIs
StatePublished - Jun 2 2016

Fingerprint

Stillbirth
Adrenal Cortex Hormones
Premature Birth
Infant Mortality
Obstetrics
Pragmatic Clinical Trials
Mothers
Term Birth
Guatemala
Zambia
Kenya
Pakistan
Argentina
Proxy
Infection
Research
Birth Weight
Health Status
Gestational Age
India

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Reproductive Medicine

Cite this

Goldenberg, R. L., Thorsten, V. R., Althabe, F., Saleem, S., Garces, A., Carlo, W. A., ... McClure, E. M. (2016). The global network antenatal corticosteroids trial: Impact on stillbirth. Reproductive Health, 13(1), [68]. https://doi.org/10.1186/s12978-016-0174-4

The global network antenatal corticosteroids trial : Impact on stillbirth. / Goldenberg, Robert L.; Thorsten, Vanessa R.; Althabe, Fernando; Saleem, Sarah; Garces, Ana; Carlo, Waldemar A.; Pasha, Omrana; Chomba, Elwyn; Goudar, Shivaprasad; Esamai, Fabian; Krebs, Nancy F.; Derman, Richard J.; Liechty, Edward A.; Patel, Archana; Hibberd, Patricia L.; Buekens, Pierre M.; Koso-Thomas, Marion; Miodovnik, Menachem; Jobe, Alan H.; Wallace, Dennis D.; Belizán, José M.; McClure, Elizabeth M.

In: Reproductive Health, Vol. 13, No. 1, 68, 02.06.2016.

Research output: Contribution to journalArticle

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, Belizán, JM & McClure, EM 2016, 'The global network antenatal corticosteroids trial: Impact on stillbirth', Reproductive Health, vol. 13, no. 1, 68. https://doi.org/10.1186/s12978-016-0174-4
Goldenberg RL, Thorsten VR, Althabe F, Saleem S, Garces A, Carlo WA et al. The global network antenatal corticosteroids trial: Impact on stillbirth. Reproductive Health. 2016 Jun 2;13(1). 68. https://doi.org/10.1186/s12978-016-0174-4
Goldenberg, Robert L. ; Thorsten, Vanessa R. ; Althabe, Fernando ; Saleem, Sarah ; Garces, Ana ; Carlo, Waldemar A. ; Pasha, Omrana ; Chomba, Elwyn ; Goudar, Shivaprasad ; Esamai, Fabian ; Krebs, Nancy F. ; Derman, Richard J. ; Liechty, Edward A. ; Patel, Archana ; Hibberd, Patricia L. ; Buekens, Pierre M. ; Koso-Thomas, Marion ; Miodovnik, Menachem ; Jobe, Alan H. ; Wallace, Dennis D. ; Belizán, José M. ; McClure, Elizabeth M. / The global network antenatal corticosteroids trial : Impact on stillbirth. In: Reproductive Health. 2016 ; Vol. 13, No. 1.
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abstract = "Background: Antenatal corticosteroids are commonly used to reduce neonatal mortality, but most research to date has been in high-resource settings and few studies have evaluated its impact on stillbirth. In the Antenatal Corticosteroids Trial (ACT), a multi-country trial to assess impact of a multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth, we found an overall increase in 28-day neonatal mortality and stillbirth associated with the intervention. Methods: The ACT was a cluster-randomized trial conducted in 102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk. Because of inadequate gestational age dating, the <5th percentile birth weight was used as a proxy for preterm birth. A pre-specified secondary outcome of the trial was stillbirth. Results: After adjusting for the pre-trial imbalance in stillbirth rates, the ACT intervention was associated with a non-significant increased risk of stillbirth (aRR 1.08, 95 {\%} CI, 0.99-1.17, p-0.073). Additionally, the stillbirth rate was higher in the term births (1.20 95 {\%} CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters. Differences in obstetric care favored the control clusters and maternal infection was likely more common in the intervention clusters. Conclusions: In this pragmatic trial, limited data were available to identify the causes of the increase in stillbirths in the intervention clusters. A higher rate of stillbirth in the intervention clusters prior to the trial, differences in obstetric care and an increase in maternal infection are potential explanations for the observed increase in stillbirths in the intervention clusters during the trial. Trial registration: clinicaltrials.gov (NCT01084096)",
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T2 - Impact on stillbirth

AU - Goldenberg, Robert L.

AU - Thorsten, Vanessa R.

AU - Althabe, Fernando

AU - Saleem, Sarah

AU - Garces, Ana

AU - Carlo, Waldemar A.

AU - Pasha, Omrana

AU - Chomba, Elwyn

AU - Goudar, Shivaprasad

AU - Esamai, Fabian

AU - Krebs, Nancy F.

AU - Derman, Richard J.

AU - Liechty, Edward A.

AU - Patel, Archana

AU - Hibberd, Patricia L.

AU - Buekens, Pierre M.

AU - Koso-Thomas, Marion

AU - Miodovnik, Menachem

AU - Jobe, Alan H.

AU - Wallace, Dennis D.

AU - Belizán, José M.

AU - McClure, Elizabeth M.

PY - 2016/6/2

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N2 - Background: Antenatal corticosteroids are commonly used to reduce neonatal mortality, but most research to date has been in high-resource settings and few studies have evaluated its impact on stillbirth. In the Antenatal Corticosteroids Trial (ACT), a multi-country trial to assess impact of a multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth, we found an overall increase in 28-day neonatal mortality and stillbirth associated with the intervention. Methods: The ACT was a cluster-randomized trial conducted in 102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk. Because of inadequate gestational age dating, the <5th percentile birth weight was used as a proxy for preterm birth. A pre-specified secondary outcome of the trial was stillbirth. Results: After adjusting for the pre-trial imbalance in stillbirth rates, the ACT intervention was associated with a non-significant increased risk of stillbirth (aRR 1.08, 95 % CI, 0.99-1.17, p-0.073). Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters. Differences in obstetric care favored the control clusters and maternal infection was likely more common in the intervention clusters. Conclusions: In this pragmatic trial, limited data were available to identify the causes of the increase in stillbirths in the intervention clusters. A higher rate of stillbirth in the intervention clusters prior to the trial, differences in obstetric care and an increase in maternal infection are potential explanations for the observed increase in stillbirths in the intervention clusters during the trial. Trial registration: clinicaltrials.gov (NCT01084096)

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