The global network antenatal corticosteroids trial: impact on stillbirth

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 <$ 5^{th} $ 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) Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Goldenberg, Robert L. [verfasserIn] 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.

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2016

Schlagwörter:	Preterm Birth Neonatal Mortality Intervention Cluster Stillbirth Rate Last Menstrual Period

Anmerkung:	© Goldenberg et al. 2016

Übergeordnetes Werk:	Enthalten in: Reproductive health - London : BioMed Central, 2004, 13(2016), 1 vom: 02. Juni
Übergeordnetes Werk:	volume:13 ; year:2016 ; number:1 ; day:02 ; month:06

Links:	Volltext

DOI / URN:	10.1186/s12978-016-0174-4

Katalog-ID:	SPR029188105

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245	1	4	\|a The global network antenatal corticosteroids trial: impact on stillbirth
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520			\|a 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 <$ 5^{th} $ 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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allfields	10.1186/s12978-016-0174-4 doi (DE-627)SPR029188105 (SPR)s12978-016-0174-4-e DE-627 ger DE-627 rakwb eng Goldenberg, Robert L. verfasserin aut The global network antenatal corticosteroids trial: impact on stillbirth 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Goldenberg et al. 2016 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 <$ 5^{th} $ 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) Preterm Birth (dpeaa)DE-He213 Neonatal Mortality (dpeaa)DE-He213 Intervention Cluster (dpeaa)DE-He213 Stillbirth Rate (dpeaa)DE-He213 Last Menstrual Period (dpeaa)DE-He213 Thorsten, Vanessa R. aut Althabe, Fernando aut Saleem, Sarah aut Garces, Ana aut Carlo, Waldemar A. aut Pasha, Omrana aut Chomba, Elwyn aut Goudar, Shivaprasad aut Esamai, Fabian aut Krebs, Nancy F. aut Derman, Richard J. aut Liechty, Edward A. aut Patel, Archana aut Hibberd, Patricia L. aut Buekens, Pierre M. aut Koso-Thomas, Marion aut Miodovnik, Menachem aut Jobe, Alan H. aut Wallace, Dennis D. aut Belizán, José M. aut McClure, Elizabeth M. aut Enthalten in Reproductive health London : BioMed Central, 2004 13(2016), 1 vom: 02. Juni (DE-627)389462543 (DE-600)2149029-6 1742-4755 nnns volume:13 year:2016 number:1 day:02 month:06 https://dx.doi.org/10.1186/s12978-016-0174-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13 2016 1 02 06
spelling	10.1186/s12978-016-0174-4 doi (DE-627)SPR029188105 (SPR)s12978-016-0174-4-e DE-627 ger DE-627 rakwb eng Goldenberg, Robert L. verfasserin aut The global network antenatal corticosteroids trial: impact on stillbirth 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Goldenberg et al. 2016 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 <$ 5^{th} $ 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) Preterm Birth (dpeaa)DE-He213 Neonatal Mortality (dpeaa)DE-He213 Intervention Cluster (dpeaa)DE-He213 Stillbirth Rate (dpeaa)DE-He213 Last Menstrual Period (dpeaa)DE-He213 Thorsten, Vanessa R. aut Althabe, Fernando aut Saleem, Sarah aut Garces, Ana aut Carlo, Waldemar A. aut Pasha, Omrana aut Chomba, Elwyn aut Goudar, Shivaprasad aut Esamai, Fabian aut Krebs, Nancy F. aut Derman, Richard J. aut Liechty, Edward A. aut Patel, Archana aut Hibberd, Patricia L. aut Buekens, Pierre M. aut Koso-Thomas, Marion aut Miodovnik, Menachem aut Jobe, Alan H. aut Wallace, Dennis D. aut Belizán, José M. aut McClure, Elizabeth M. aut Enthalten in Reproductive health London : BioMed Central, 2004 13(2016), 1 vom: 02. Juni (DE-627)389462543 (DE-600)2149029-6 1742-4755 nnns volume:13 year:2016 number:1 day:02 month:06 https://dx.doi.org/10.1186/s12978-016-0174-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13 2016 1 02 06
allfields_unstemmed	10.1186/s12978-016-0174-4 doi (DE-627)SPR029188105 (SPR)s12978-016-0174-4-e DE-627 ger DE-627 rakwb eng Goldenberg, Robert L. verfasserin aut The global network antenatal corticosteroids trial: impact on stillbirth 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Goldenberg et al. 2016 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 <$ 5^{th} $ 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) Preterm Birth (dpeaa)DE-He213 Neonatal Mortality (dpeaa)DE-He213 Intervention Cluster (dpeaa)DE-He213 Stillbirth Rate (dpeaa)DE-He213 Last Menstrual Period (dpeaa)DE-He213 Thorsten, Vanessa R. aut Althabe, Fernando aut Saleem, Sarah aut Garces, Ana aut Carlo, Waldemar A. aut Pasha, Omrana aut Chomba, Elwyn aut Goudar, Shivaprasad aut Esamai, Fabian aut Krebs, Nancy F. aut Derman, Richard J. aut Liechty, Edward A. aut Patel, Archana aut Hibberd, Patricia L. aut Buekens, Pierre M. aut Koso-Thomas, Marion aut Miodovnik, Menachem aut Jobe, Alan H. aut Wallace, Dennis D. aut Belizán, José M. aut McClure, Elizabeth M. aut Enthalten in Reproductive health London : BioMed Central, 2004 13(2016), 1 vom: 02. Juni (DE-627)389462543 (DE-600)2149029-6 1742-4755 nnns volume:13 year:2016 number:1 day:02 month:06 https://dx.doi.org/10.1186/s12978-016-0174-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13 2016 1 02 06
allfieldsGer	10.1186/s12978-016-0174-4 doi (DE-627)SPR029188105 (SPR)s12978-016-0174-4-e DE-627 ger DE-627 rakwb eng Goldenberg, Robert L. verfasserin aut The global network antenatal corticosteroids trial: impact on stillbirth 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Goldenberg et al. 2016 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 <$ 5^{th} $ 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) Preterm Birth (dpeaa)DE-He213 Neonatal Mortality (dpeaa)DE-He213 Intervention Cluster (dpeaa)DE-He213 Stillbirth Rate (dpeaa)DE-He213 Last Menstrual Period (dpeaa)DE-He213 Thorsten, Vanessa R. aut Althabe, Fernando aut Saleem, Sarah aut Garces, Ana aut Carlo, Waldemar A. aut Pasha, Omrana aut Chomba, Elwyn aut Goudar, Shivaprasad aut Esamai, Fabian aut Krebs, Nancy F. aut Derman, Richard J. aut Liechty, Edward A. aut Patel, Archana aut Hibberd, Patricia L. aut Buekens, Pierre M. aut Koso-Thomas, Marion aut Miodovnik, Menachem aut Jobe, Alan H. aut Wallace, Dennis D. aut Belizán, José M. aut McClure, Elizabeth M. aut Enthalten in Reproductive health London : BioMed Central, 2004 13(2016), 1 vom: 02. Juni (DE-627)389462543 (DE-600)2149029-6 1742-4755 nnns volume:13 year:2016 number:1 day:02 month:06 https://dx.doi.org/10.1186/s12978-016-0174-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13 2016 1 02 06
allfieldsSound	10.1186/s12978-016-0174-4 doi (DE-627)SPR029188105 (SPR)s12978-016-0174-4-e DE-627 ger DE-627 rakwb eng Goldenberg, Robert L. verfasserin aut The global network antenatal corticosteroids trial: impact on stillbirth 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Goldenberg et al. 2016 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 <$ 5^{th} $ 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) Preterm Birth (dpeaa)DE-He213 Neonatal Mortality (dpeaa)DE-He213 Intervention Cluster (dpeaa)DE-He213 Stillbirth Rate (dpeaa)DE-He213 Last Menstrual Period (dpeaa)DE-He213 Thorsten, Vanessa R. aut Althabe, Fernando aut Saleem, Sarah aut Garces, Ana aut Carlo, Waldemar A. aut Pasha, Omrana aut Chomba, Elwyn aut Goudar, Shivaprasad aut Esamai, Fabian aut Krebs, Nancy F. aut Derman, Richard J. aut Liechty, Edward A. aut Patel, Archana aut Hibberd, Patricia L. aut Buekens, Pierre M. aut Koso-Thomas, Marion aut Miodovnik, Menachem aut Jobe, Alan H. aut Wallace, Dennis D. aut Belizán, José M. aut McClure, Elizabeth M. aut Enthalten in Reproductive health London : BioMed Central, 2004 13(2016), 1 vom: 02. Juni (DE-627)389462543 (DE-600)2149029-6 1742-4755 nnns volume:13 year:2016 number:1 day:02 month:06 https://dx.doi.org/10.1186/s12978-016-0174-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13 2016 1 02 06
language	English
source	Enthalten in Reproductive health 13(2016), 1 vom: 02. Juni volume:13 year:2016 number:1 day:02 month:06
sourceStr	Enthalten in Reproductive health 13(2016), 1 vom: 02. Juni volume:13 year:2016 number:1 day:02 month:06
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Preterm Birth Neonatal Mortality Intervention Cluster Stillbirth Rate Last Menstrual Period
isfreeaccess_bool	true
container_title	Reproductive health
authorswithroles_txt_mv	Goldenberg, Robert L. @@aut@@ Thorsten, Vanessa R. @@aut@@ Althabe, Fernando @@aut@@ Saleem, Sarah @@aut@@ Garces, Ana @@aut@@ Carlo, Waldemar A. @@aut@@ Pasha, Omrana @@aut@@ Chomba, Elwyn @@aut@@ Goudar, Shivaprasad @@aut@@ Esamai, Fabian @@aut@@ Krebs, Nancy F. @@aut@@ Derman, Richard J. @@aut@@ Liechty, Edward A. @@aut@@ Patel, Archana @@aut@@ Hibberd, Patricia L. @@aut@@ Buekens, Pierre M. @@aut@@ Koso-Thomas, Marion @@aut@@ Miodovnik, Menachem @@aut@@ Jobe, Alan H. @@aut@@ Wallace, Dennis D. @@aut@@ Belizán, José M. @@aut@@ McClure, Elizabeth M. @@aut@@
publishDateDaySort_date	2016-06-02T00:00:00Z
hierarchy_top_id	389462543
id	SPR029188105
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR029188105</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519124120.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2016 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s12978-016-0174-4</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR029188105</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s12978-016-0174-4-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Goldenberg, Robert L.</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="4"><subfield code="a">The global network antenatal corticosteroids trial: impact on stillbirth</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2016</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© Goldenberg et al. 2016</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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 <$ 5^{th} $ 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. 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author	Goldenberg, Robert L.
spellingShingle	Goldenberg, Robert L. misc Preterm Birth misc Neonatal Mortality misc Intervention Cluster misc Stillbirth Rate misc Last Menstrual Period The global network antenatal corticosteroids trial: impact on stillbirth
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topic_title	The global network antenatal corticosteroids trial: impact on stillbirth Preterm Birth (dpeaa)DE-He213 Neonatal Mortality (dpeaa)DE-He213 Intervention Cluster (dpeaa)DE-He213 Stillbirth Rate (dpeaa)DE-He213 Last Menstrual Period (dpeaa)DE-He213
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title	The global network antenatal corticosteroids trial: impact on stillbirth
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title_full	The global network antenatal corticosteroids trial: impact on stillbirth
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author_browse	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.
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title_sort	global network antenatal corticosteroids trial: impact on stillbirth
title_auth	The global network antenatal corticosteroids trial: impact on stillbirth
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 <$ 5^{th} $ 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) © Goldenberg et al. 2016
abstractGer	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 <$ 5^{th} $ 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) © Goldenberg et al. 2016
abstract_unstemmed	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 <$ 5^{th} $ 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) © Goldenberg et al. 2016
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title_short	The global network antenatal corticosteroids trial: impact on stillbirth
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author2	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.
author2Str	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.
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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 <$ 5^{th} $ 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. 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The global network antenatal corticosteroids trial: impact on stillbirth

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