Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.

We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologica...

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Main Authors: Emily R Smith, Erin Oakley, Siran He, Rebecca Zavala, Kacey Ferguson, Lior Miller, Gargi Wable Grandner, Ibukun-Oluwa Omolade Abejirinde, Yalda Afshar, Homa Ahmadzia, Grace Aldrovandi, Victor Akelo, Beth A Tippett Barr, Elisa Bevilacqua, Justin S Brandt, Natalie Broutet, Irene Fernández Buhigas, Jorge Carrillo, Rebecca Clifton, Jeanne Conry, Erich Cosmi, Camille Delgado-López, Hema Divakar, Amanda J Driscoll, Guillaume Favre, Valerie Flaherman, Christopher Gale, Maria M Gil, Christine Godwin, Sami Gottlieb, Olivia Hernandez Bellolio, Edna Kara, Sammy Khagayi, Caron Rahn Kim, Marian Knight, Karen Kotloff, Antonio Lanzone, Kirsty Le Doare, Christoph Lees, Ethan Litman, Erica M Lokken, Valentina Laurita Longo, Laura A Magee, Raigam Jafet Martinez-Portilla, Elizabeth McClure, Torri D Metz, Deborah Money, Edward Mullins, Jean B Nachega, Alice Panchaud, Rebecca Playle, Liona C Poon, Daniel Raiten, Lesley Regan, Gordon Rukundo, Jose Sanin-Blair, Marleen Temmerman, Anna Thorson, Soe Thwin, Jorge E Tolosa, Julia Townson, Miguel Valencia-Prado, Silvia Visentin, Peter von Dadelszen, Kristina Adams Waldorf, Clare Whitehead, Huixia Yang, Kristian Thorlund, James M Tielsch
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2022-01-01
Series:PLoS ONE
Online Access:https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0270150&type=printable
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author Emily R Smith
Erin Oakley
Siran He
Rebecca Zavala
Kacey Ferguson
Lior Miller
Gargi Wable Grandner
Ibukun-Oluwa Omolade Abejirinde
Yalda Afshar
Homa Ahmadzia
Grace Aldrovandi
Victor Akelo
Beth A Tippett Barr
Elisa Bevilacqua
Justin S Brandt
Natalie Broutet
Irene Fernández Buhigas
Jorge Carrillo
Rebecca Clifton
Jeanne Conry
Erich Cosmi
Camille Delgado-López
Hema Divakar
Amanda J Driscoll
Guillaume Favre
Valerie Flaherman
Christopher Gale
Maria M Gil
Christine Godwin
Sami Gottlieb
Olivia Hernandez Bellolio
Edna Kara
Sammy Khagayi
Caron Rahn Kim
Marian Knight
Karen Kotloff
Antonio Lanzone
Kirsty Le Doare
Christoph Lees
Ethan Litman
Erica M Lokken
Valentina Laurita Longo
Laura A Magee
Raigam Jafet Martinez-Portilla
Elizabeth McClure
Torri D Metz
Deborah Money
Edward Mullins
Jean B Nachega
Alice Panchaud
Rebecca Playle
Liona C Poon
Daniel Raiten
Lesley Regan
Gordon Rukundo
Jose Sanin-Blair
Marleen Temmerman
Anna Thorson
Soe Thwin
Jorge E Tolosa
Julia Townson
Miguel Valencia-Prado
Silvia Visentin
Peter von Dadelszen
Kristina Adams Waldorf
Clare Whitehead
Huixia Yang
Kristian Thorlund
James M Tielsch
author_facet Emily R Smith
Erin Oakley
Siran He
Rebecca Zavala
Kacey Ferguson
Lior Miller
Gargi Wable Grandner
Ibukun-Oluwa Omolade Abejirinde
Yalda Afshar
Homa Ahmadzia
Grace Aldrovandi
Victor Akelo
Beth A Tippett Barr
Elisa Bevilacqua
Justin S Brandt
Natalie Broutet
Irene Fernández Buhigas
Jorge Carrillo
Rebecca Clifton
Jeanne Conry
Erich Cosmi
Camille Delgado-López
Hema Divakar
Amanda J Driscoll
Guillaume Favre
Valerie Flaherman
Christopher Gale
Maria M Gil
Christine Godwin
Sami Gottlieb
Olivia Hernandez Bellolio
Edna Kara
Sammy Khagayi
Caron Rahn Kim
Marian Knight
Karen Kotloff
Antonio Lanzone
Kirsty Le Doare
Christoph Lees
Ethan Litman
Erica M Lokken
Valentina Laurita Longo
Laura A Magee
Raigam Jafet Martinez-Portilla
Elizabeth McClure
Torri D Metz
Deborah Money
Edward Mullins
Jean B Nachega
Alice Panchaud
Rebecca Playle
Liona C Poon
Daniel Raiten
Lesley Regan
Gordon Rukundo
Jose Sanin-Blair
Marleen Temmerman
Anna Thorson
Soe Thwin
Jorge E Tolosa
Julia Townson
Miguel Valencia-Prado
Silvia Visentin
Peter von Dadelszen
Kristina Adams Waldorf
Clare Whitehead
Huixia Yang
Kristian Thorlund
James M Tielsch
author_sort Emily R Smith
collection DOAJ
description We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.
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spelling doaj-art-58551598e6fb42e595bdddd9beb896442025-08-20T03:28:50ZengPublic Library of Science (PLoS)PLoS ONE1932-62032022-01-01176e027015010.1371/journal.pone.0270150Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.Emily R SmithErin OakleySiran HeRebecca ZavalaKacey FergusonLior MillerGargi Wable GrandnerIbukun-Oluwa Omolade AbejirindeYalda AfsharHoma AhmadziaGrace AldrovandiVictor AkeloBeth A Tippett BarrElisa BevilacquaJustin S BrandtNatalie BroutetIrene Fernández BuhigasJorge CarrilloRebecca CliftonJeanne ConryErich CosmiCamille Delgado-LópezHema DivakarAmanda J DriscollGuillaume FavreValerie FlahermanChristopher GaleMaria M GilChristine GodwinSami GottliebOlivia Hernandez BellolioEdna KaraSammy KhagayiCaron Rahn KimMarian KnightKaren KotloffAntonio LanzoneKirsty Le DoareChristoph LeesEthan LitmanErica M LokkenValentina Laurita LongoLaura A MageeRaigam Jafet Martinez-PortillaElizabeth McClureTorri D MetzDeborah MoneyEdward MullinsJean B NachegaAlice PanchaudRebecca PlayleLiona C PoonDaniel RaitenLesley ReganGordon RukundoJose Sanin-BlairMarleen TemmermanAnna ThorsonSoe ThwinJorge E TolosaJulia TownsonMiguel Valencia-PradoSilvia VisentinPeter von DadelszenKristina Adams WaldorfClare WhiteheadHuixia YangKristian ThorlundJames M TielschWe urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0270150&type=printable
spellingShingle Emily R Smith
Erin Oakley
Siran He
Rebecca Zavala
Kacey Ferguson
Lior Miller
Gargi Wable Grandner
Ibukun-Oluwa Omolade Abejirinde
Yalda Afshar
Homa Ahmadzia
Grace Aldrovandi
Victor Akelo
Beth A Tippett Barr
Elisa Bevilacqua
Justin S Brandt
Natalie Broutet
Irene Fernández Buhigas
Jorge Carrillo
Rebecca Clifton
Jeanne Conry
Erich Cosmi
Camille Delgado-López
Hema Divakar
Amanda J Driscoll
Guillaume Favre
Valerie Flaherman
Christopher Gale
Maria M Gil
Christine Godwin
Sami Gottlieb
Olivia Hernandez Bellolio
Edna Kara
Sammy Khagayi
Caron Rahn Kim
Marian Knight
Karen Kotloff
Antonio Lanzone
Kirsty Le Doare
Christoph Lees
Ethan Litman
Erica M Lokken
Valentina Laurita Longo
Laura A Magee
Raigam Jafet Martinez-Portilla
Elizabeth McClure
Torri D Metz
Deborah Money
Edward Mullins
Jean B Nachega
Alice Panchaud
Rebecca Playle
Liona C Poon
Daniel Raiten
Lesley Regan
Gordon Rukundo
Jose Sanin-Blair
Marleen Temmerman
Anna Thorson
Soe Thwin
Jorge E Tolosa
Julia Townson
Miguel Valencia-Prado
Silvia Visentin
Peter von Dadelszen
Kristina Adams Waldorf
Clare Whitehead
Huixia Yang
Kristian Thorlund
James M Tielsch
Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.
PLoS ONE
title Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.
title_full Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.
title_fullStr Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.
title_full_unstemmed Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.
title_short Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.
title_sort protocol for a sequential prospective meta analysis to describe coronavirus disease 2019 covid 19 in the pregnancy and postpartum periods
url https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0270150&type=printable
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