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Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial

Background: Group antenatal care has demonstrated promise as a service delivery model that may result in improved outcomes compared to standard antenatal care in socio-demographic populations at disparately high risk for poor perinatal outcomes. Intrigued by results from the United States showing lo...

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Autores principales: Musange, Sabine Furere, Butrick, Elizabeth, Lundeen, Tiffany, Santos, Nicole, Azman Firdaus, Hana, Benitez, Alejandra, Nzeyimana, David, Kayiramirwa Murindahabi, Nathalie, Nyiraneza, Lauriane, Sayinzoga, Felix, Ndahindwa, Vedaste, Ngabo, Fidele, Condo, Jeanine, Walker, Dylis
Formato: Online Artículo Texto
Lenguaje:English
Publicado: F1000 Research Limited 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6792348/
https://www.ncbi.nlm.nih.gov/pubmed/31656954
http://dx.doi.org/10.12688/gatesopenres.13053.1
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author Musange, Sabine Furere
Butrick, Elizabeth
Lundeen, Tiffany
Santos, Nicole
Azman Firdaus, Hana
Benitez, Alejandra
Nzeyimana, David
Kayiramirwa Murindahabi, Nathalie
Nyiraneza, Lauriane
Sayinzoga, Felix
Ndahindwa, Vedaste
Ngabo, Fidele
Condo, Jeanine
Walker, Dylis
author_facet Musange, Sabine Furere
Butrick, Elizabeth
Lundeen, Tiffany
Santos, Nicole
Azman Firdaus, Hana
Benitez, Alejandra
Nzeyimana, David
Kayiramirwa Murindahabi, Nathalie
Nyiraneza, Lauriane
Sayinzoga, Felix
Ndahindwa, Vedaste
Ngabo, Fidele
Condo, Jeanine
Walker, Dylis
author_sort Musange, Sabine Furere
collection PubMed
description Background: Group antenatal care has demonstrated promise as a service delivery model that may result in improved outcomes compared to standard antenatal care in socio-demographic populations at disparately high risk for poor perinatal outcomes. Intrigued by results from the United States showing lower preterm birth rates among high-risk women who participate in group antenatal care, partners working together as the Preterm Birth Initiative - Rwanda designed a trial to assess the impact of group antenatal care on gestational age at birth. Methods: This study is a pair-matched cluster randomized controlled trial with four arms. Pairs randomized to group or standard care were further matched with other pairs into quadruples, within which one pair was assigned to implement basic obstetric ultrasound at the health center and early pregnancy testing at the community. At facilities randomized to group care, this will follow the opt-out model of service delivery and individual visits will always be available for those who need or prefer them. The primary outcome of interest is mean gestational age at birth among women who presented for antenatal care before 24 completed weeks of pregnancy and attended more than one antenatal care visit. Secondary outcomes of interest include attendance at antenatal and postnatal care, preterm birth rates, satisfaction of mothers and providers, and feasibility. A convenience sample of women will be recruited to participate in a longitudinal survey in which they will report such indicators as self-reported health-related behaviors and depressive symptoms. Providers will be surveyed about satisfaction and stress. Discussion: This is the largest cluster randomized controlled trial of group antenatal and postnatal care ever conducted, and the first in a low- or middle-income country to examine the effect of this model on gestational age at birth. Trial registration: This study is registered on ClinicalTrials.gov as NCT03154177 May 16, 2017.
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spelling pubmed-67923482019-10-25 Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial Musange, Sabine Furere Butrick, Elizabeth Lundeen, Tiffany Santos, Nicole Azman Firdaus, Hana Benitez, Alejandra Nzeyimana, David Kayiramirwa Murindahabi, Nathalie Nyiraneza, Lauriane Sayinzoga, Felix Ndahindwa, Vedaste Ngabo, Fidele Condo, Jeanine Walker, Dylis Gates Open Res Study Protocol Background: Group antenatal care has demonstrated promise as a service delivery model that may result in improved outcomes compared to standard antenatal care in socio-demographic populations at disparately high risk for poor perinatal outcomes. Intrigued by results from the United States showing lower preterm birth rates among high-risk women who participate in group antenatal care, partners working together as the Preterm Birth Initiative - Rwanda designed a trial to assess the impact of group antenatal care on gestational age at birth. Methods: This study is a pair-matched cluster randomized controlled trial with four arms. Pairs randomized to group or standard care were further matched with other pairs into quadruples, within which one pair was assigned to implement basic obstetric ultrasound at the health center and early pregnancy testing at the community. At facilities randomized to group care, this will follow the opt-out model of service delivery and individual visits will always be available for those who need or prefer them. The primary outcome of interest is mean gestational age at birth among women who presented for antenatal care before 24 completed weeks of pregnancy and attended more than one antenatal care visit. Secondary outcomes of interest include attendance at antenatal and postnatal care, preterm birth rates, satisfaction of mothers and providers, and feasibility. A convenience sample of women will be recruited to participate in a longitudinal survey in which they will report such indicators as self-reported health-related behaviors and depressive symptoms. Providers will be surveyed about satisfaction and stress. Discussion: This is the largest cluster randomized controlled trial of group antenatal and postnatal care ever conducted, and the first in a low- or middle-income country to examine the effect of this model on gestational age at birth. Trial registration: This study is registered on ClinicalTrials.gov as NCT03154177 May 16, 2017. F1000 Research Limited 2019-09-27 /pmc/articles/PMC6792348/ /pubmed/31656954 http://dx.doi.org/10.12688/gatesopenres.13053.1 Text en Copyright: © 2019 Musange SF et al. http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Musange, Sabine Furere
Butrick, Elizabeth
Lundeen, Tiffany
Santos, Nicole
Azman Firdaus, Hana
Benitez, Alejandra
Nzeyimana, David
Kayiramirwa Murindahabi, Nathalie
Nyiraneza, Lauriane
Sayinzoga, Felix
Ndahindwa, Vedaste
Ngabo, Fidele
Condo, Jeanine
Walker, Dylis
Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial
title Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial
title_full Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial
title_fullStr Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial
title_full_unstemmed Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial
title_short Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial
title_sort group antenatal care versus standard antenatal care and effect on mean gestational age at birth in rwanda: protocol for a cluster randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6792348/
https://www.ncbi.nlm.nih.gov/pubmed/31656954
http://dx.doi.org/10.12688/gatesopenres.13053.1
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