A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: A Global Network cluster randomized trial

Omrana Pasha, Elizabeth M. McClure, Linda L. Wright, Sarah Saleem, Shivaprasad S. Goudar, Elwyn Chomba, Archana Patel, Fabian Esamai, Ana Garces, Fernando Althabe, Bhala Kodkany, Hillary Mabeya, Albert Manasyan, Waldemar A. Carlo, Richard J. Derman, Patricia L. Hibberd, Edward K. Liechty, Nancy Krebs, K. M. Hambidge, Pierre BuekensJanet Moore, Alan H. Jobe, Marion Koso-Thomas, Dennis D. Wallace, Suzanne Stalls, Robert L. Goldenberg, Agustina Mazzoni, Marina Laski, Ariel Karolinski, Mabel Berrueta, Christine Kaseba, Evelyn Morales, N. S. Mahantshetti, N. V. Honnungar, Kamal Patil, M. K. Swamy, Sadiah Ahsan, Khadim Hussain, Azra Ahsan, Manju Waikar, Nivedita Kulkarni, Sushama Thakre, Manoj Bhatnagar, Betsy Rono, Peter Gisore, Hillary Mbeya

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Background: Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care. Methods: This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g. Results: Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention. Conclusions: This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training and community mobilization will not be sufficient. Our results highlight the critical importance of evaluating outcomes in randomized trials, as interventions that should be effective may not be.Trial registration: ClinicalTrials.gov NCT01073488.

Original languageEnglish
Article number215
JournalBMC Medicine
Volume11
Issue number1
DOIs
StatePublished - Oct 3 2013

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Perinatal Mortality
Pregnancy Outcome
Obstetrics
Parturition
Hospital Planning
Fetal Mortality
Mortality
Infant Mortality
Administrative Personnel
Birth Weight
Health Personnel
Emergencies
Pregnancy

Keywords

  • Emergency obstetric care
  • Maternal mortality
  • Neonatal mortality
  • Stillbirth

ASJC Scopus subject areas

  • Medicine(all)

Cite this

A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings : A Global Network cluster randomized trial. / Pasha, Omrana; McClure, Elizabeth M.; Wright, Linda L.; Saleem, Sarah; Goudar, Shivaprasad S.; Chomba, Elwyn; Patel, Archana; Esamai, Fabian; Garces, Ana; Althabe, Fernando; Kodkany, Bhala; Mabeya, Hillary; Manasyan, Albert; Carlo, Waldemar A.; Derman, Richard J.; Hibberd, Patricia L.; Liechty, Edward K.; Krebs, Nancy; Hambidge, K. M.; Buekens, Pierre; Moore, Janet; Jobe, Alan H.; Koso-Thomas, Marion; Wallace, Dennis D.; Stalls, Suzanne; Goldenberg, Robert L.; Mazzoni, Agustina; Laski, Marina; Karolinski, Ariel; Berrueta, Mabel; Kaseba, Christine; Morales, Evelyn; Mahantshetti, N. S.; Honnungar, N. V.; Patil, Kamal; Swamy, M. K.; Ahsan, Sadiah; Hussain, Khadim; Ahsan, Azra; Waikar, Manju; Kulkarni, Nivedita; Thakre, Sushama; Bhatnagar, Manoj; Rono, Betsy; Gisore, Peter; Mbeya, Hillary.

In: BMC Medicine, Vol. 11, No. 1, 215, 03.10.2013.

Research output: Contribution to journalArticle

Pasha, O, McClure, EM, Wright, LL, Saleem, S, Goudar, SS, Chomba, E, Patel, A, Esamai, F, Garces, A, Althabe, F, Kodkany, B, Mabeya, H, Manasyan, A, Carlo, WA, Derman, RJ, Hibberd, PL, Liechty, EK, Krebs, N, Hambidge, KM, Buekens, P, Moore, J, Jobe, AH, Koso-Thomas, M, Wallace, DD, Stalls, S, Goldenberg, RL, Mazzoni, A, Laski, M, Karolinski, A, Berrueta, M, Kaseba, C, Morales, E, Mahantshetti, NS, Honnungar, NV, Patil, K, Swamy, MK, Ahsan, S, Hussain, K, Ahsan, A, Waikar, M, Kulkarni, N, Thakre, S, Bhatnagar, M, Rono, B, Gisore, P & Mbeya, H 2013, 'A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: A Global Network cluster randomized trial', BMC Medicine, vol. 11, no. 1, 215. https://doi.org/10.1186/1741-7015-11-215
Pasha, Omrana ; McClure, Elizabeth M. ; Wright, Linda L. ; Saleem, Sarah ; Goudar, Shivaprasad S. ; Chomba, Elwyn ; Patel, Archana ; Esamai, Fabian ; Garces, Ana ; Althabe, Fernando ; Kodkany, Bhala ; Mabeya, Hillary ; Manasyan, Albert ; Carlo, Waldemar A. ; Derman, Richard J. ; Hibberd, Patricia L. ; Liechty, Edward K. ; Krebs, Nancy ; Hambidge, K. M. ; Buekens, Pierre ; Moore, Janet ; Jobe, Alan H. ; Koso-Thomas, Marion ; Wallace, Dennis D. ; Stalls, Suzanne ; Goldenberg, Robert L. ; Mazzoni, Agustina ; Laski, Marina ; Karolinski, Ariel ; Berrueta, Mabel ; Kaseba, Christine ; Morales, Evelyn ; Mahantshetti, N. S. ; Honnungar, N. V. ; Patil, Kamal ; Swamy, M. K. ; Ahsan, Sadiah ; Hussain, Khadim ; Ahsan, Azra ; Waikar, Manju ; Kulkarni, Nivedita ; Thakre, Sushama ; Bhatnagar, Manoj ; Rono, Betsy ; Gisore, Peter ; Mbeya, Hillary. / A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings : A Global Network cluster randomized trial. In: BMC Medicine. 2013 ; Vol. 11, No. 1.
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TY - JOUR

T1 - A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings

T2 - A Global Network cluster randomized trial

AU - Pasha, Omrana

AU - McClure, Elizabeth M.

AU - Wright, Linda L.

AU - Saleem, Sarah

AU - Goudar, Shivaprasad S.

AU - Chomba, Elwyn

AU - Patel, Archana

AU - Esamai, Fabian

AU - Garces, Ana

AU - Althabe, Fernando

AU - Kodkany, Bhala

AU - Mabeya, Hillary

AU - Manasyan, Albert

AU - Carlo, Waldemar A.

AU - Derman, Richard J.

AU - Hibberd, Patricia L.

AU - Liechty, Edward K.

AU - Krebs, Nancy

AU - Hambidge, K. M.

AU - Buekens, Pierre

AU - Moore, Janet

AU - Jobe, Alan H.

AU - Koso-Thomas, Marion

AU - Wallace, Dennis D.

AU - Stalls, Suzanne

AU - Goldenberg, Robert L.

AU - Mazzoni, Agustina

AU - Laski, Marina

AU - Karolinski, Ariel

AU - Berrueta, Mabel

AU - Kaseba, Christine

AU - Morales, Evelyn

AU - Mahantshetti, N. S.

AU - Honnungar, N. V.

AU - Patil, Kamal

AU - Swamy, M. K.

AU - Ahsan, Sadiah

AU - Hussain, Khadim

AU - Ahsan, Azra

AU - Waikar, Manju

AU - Kulkarni, Nivedita

AU - Thakre, Sushama

AU - Bhatnagar, Manoj

AU - Rono, Betsy

AU - Gisore, Peter

AU - Mbeya, Hillary

PY - 2013/10/3

Y1 - 2013/10/3

N2 - Background: Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care. Methods: This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g. Results: Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention. Conclusions: This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training and community mobilization will not be sufficient. Our results highlight the critical importance of evaluating outcomes in randomized trials, as interventions that should be effective may not be.Trial registration: ClinicalTrials.gov NCT01073488.

AB - Background: Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care. Methods: This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g. Results: Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention. Conclusions: This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training and community mobilization will not be sufficient. Our results highlight the critical importance of evaluating outcomes in randomized trials, as interventions that should be effective may not be.Trial registration: ClinicalTrials.gov NCT01073488.

KW - Emergency obstetric care

KW - Maternal mortality

KW - Neonatal mortality

KW - Stillbirth

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