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

2019 ◽  
Vol 3 ◽  
pp. 1548 ◽  
Author(s):  
Sabine Furere Musange ◽  
Elizabeth Butrick ◽  
Tiffany Lundeen ◽  
Nicole Santos ◽  
Hana Azman Firdaus ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Antenatal Care ◽  
Gestational Age ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Gestational Age At Birth ◽  
Age At Birth

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.

scholarly journals An Electronic Registry for Improving the Quality of Antenatal Care in Rural Bangladesh (eRegMat): Protocol for a Cluster Randomized Controlled Trial

10.2196/26918 ◽  
2021 ◽  
Vol 10 (7) ◽  
pp. e26918
Author(s):  
Anisur Rahman ◽  
Ingrid K Friberg ◽  
Akuba Dolphyne ◽  
Ingvild Fjeldheim ◽  
Fatema Khatun ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antenatal Care ◽  
Health System ◽  
Pregnant Women ◽  
Health Worker ◽  
Controlled Trial ◽  
Health Facilities ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Cluster Randomized

Background Digital health interventions (DHIs) can alleviate several barriers to achieving better maternal and child health. The World Health Organization’s guideline recommendations for DHIs emphasize the need to integrate multiple DHIs for maximizing impact. The complex health system of Bangladesh provides a unique setting for evaluating and understanding the role of an electronic registry (eRegistry) for antenatal care, with multiple integrated DHIs for strengthening the health system as well as improving the quality and utilization of the public health care system. Objective The aim of this study is to assess the effect of an eRegistry with DHIs compared with a simple digital data entry tool without DHIs in the community and frontline health facilities. Methods The eRegMat is a cluster-randomized controlled trial conducted in the Matlab North and Matlab South subdistricts in the Chandpur district, Bangladesh, where health facilities are currently using the eRegistry for digital tracking of the health status of pregnant women longitudinally. The intervention arm received 3 superimposed data-driven DHIs: health worker clinical decision support, health worker feedback dashboards with action items, and targeted client communication to pregnant women. The primary outcomes are appropriate screening as well as management of hypertension during pregnancy and timely antenatal care attendance. The secondary outcomes include morbidity and mortality in the perinatal period as well as timely first antenatal care visit; successful referrals for anemia, diabetes, or hypertension during pregnancy; and facility delivery. Results The eRegistry and DHIs were co-designed with end users between 2016 and 2018. The eRegistry was implemented in the study area in July 2018. Recruitment for the trial started in October 2018 and ended in June 2020, followed by an 8-month follow-up period to capture outcome data until February 2021. Trial results will be available for publication in June 2021. Conclusions This trial allows the simultaneous assessment of multiple integrated DHIs for strengthening the health system and aims to provide evidence for its implementation. The study design and outcomes are geared toward informing the living review process of the guidelines for implementing DHIs. Trial Registration ISRCTN Registry ISRCTN69491836; https://www.isrctn.com/ISRCTN69491836 International Registered Report Identifier (IRRID) DERR1-10.2196/26918

scholarly journals An Electronic Registry for Improving the Quality of Antenatal Care in Rural Bangladesh (eRegMat): Protocol for a Cluster Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Anisur Rahman ◽  
Ingrid K Friberg ◽  
Akuba Dolphyne ◽  
Ingvild Fjeldheim ◽  
Fatema Khatun ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antenatal Care ◽  
Health System ◽  
Pregnant Women ◽  
Health Worker ◽  
Controlled Trial ◽  
Health Facilities ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Digital health interventions (DHIs) can alleviate several barriers to achieving better maternal and child health. The World Health Organization’s guideline recommendations for DHIs emphasize the need to integrate multiple DHIs for maximizing impact. The complex health system of Bangladesh provides a unique setting for evaluating and understanding the role of an electronic registry (eRegistry) for antenatal care, with multiple integrated DHIs for strengthening the health system as well as improving the quality and utilization of the public health care system. OBJECTIVE The aim of this study is to assess the effect of an eRegistry with DHIs compared with a simple digital data entry tool without DHIs in the community and frontline health facilities. METHODS The eRegMat is a cluster-randomized controlled trial conducted in the Matlab North and Matlab South subdistricts in the Chandpur district, Bangladesh, where health facilities are currently using the eRegistry for digital tracking of the health status of pregnant women longitudinally. The intervention arm received 3 superimposed data-driven DHIs: health worker clinical decision support, health worker feedback dashboards with action items, and targeted client communication to pregnant women. The primary outcomes are appropriate screening as well as management of hypertension during pregnancy and timely antenatal care attendance. The secondary outcomes include morbidity and mortality in the perinatal period as well as timely first antenatal care visit; successful referrals for anemia, diabetes, or hypertension during pregnancy; and facility delivery. RESULTS The eRegistry and DHIs were co-designed with end users between 2016 and 2018. The eRegistry was implemented in the study area in July 2018. Recruitment for the trial started in October 2018 and ended in June 2020, followed by an 8-month follow-up period to capture outcome data until February 2021. Trial results will be available for publication in June 2021. CONCLUSIONS This trial allows the simultaneous assessment of multiple integrated DHIs for strengthening the health system and aims to provide evidence for its implementation. The study design and outcomes are geared toward informing the living review process of the guidelines for implementing DHIs. CLINICALTRIAL ISRCTN Registry ISRCTN69491836; https://www.isrctn.com/ISRCTN69491836 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/26918

scholarly journals Effectiveness of Checklist based Box system Interventions (CBBSI) versus routine care on improving utilization of Maternal Health Service in North West, Ethiopia: Study protocol for a Cluster Randomized Controlled Trial

2019 ◽  
Author(s):  
Netsanet Belete ◽  
Mulusew Gerbaba ◽  
Gurmesa Tura
Keyword(s):  
Randomized Controlled Trial ◽  
Maternal Health ◽  
Antenatal Care ◽  
Service Utilization ◽  
Postnatal Care ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Maternal Health Service ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background-Maternal mortality is still high in Ethiopia. Antenatal care, use of skilled delivery and postnatal care are key maternal health care services that can significantly reduce maternal mortality. However, in low and middle-income countries including Ethiopia, utilization of these key services is limited, so that preventive, promotive and curative services are not provided as per the recommendation. The aim of this study is to examine the effectiveness of checklist based box system interventions on improving maternal health service utilization. Methods - A community level cluster-randomized controlled trial will be conducted to compare the effectiveness of checklist based box system interventions over the routine standard of care, as a control arm. The intervention will use health extension program and provided by health extension workers and midwives, using a special type of health education scheduling and service utilization monitoring boxes, placed at health posts and health centers respectively. For this, 1,200 pregnant mothers, below 16 weeks of gestation, will be recruited from 30 clusters. Suspected pregnant mothers will be identified through a community survey and linked to the nearby health center. With effective communication between health centers and health posts, dropout-tracing mechanisms are implemented to make mothers resume service utilization. Data will be collected using ODK-Collect and analyzed using STATA version 13.0. Data will be analyzed by intention to treat analysis. Risk ratio will be computed at cluster level and the summary will be compared using t-test. Outcomes between intervention and control groups will be compared with random effects logistic regression models. Achieving four antenatal care, health facility delivery and postnatal care visits at 6 weeks of delivery were treated as primary out comes for this study. Discussion - The authors of this study expect that, the study will generate evidence on the effectiveness of checklist based box system interventions on improving utilization of maternal health care service, that produce inputs for related policies in the country. Trial Registration – ClinicalTrials.gov NCT03891030, 26 March 2019, Retrospectively Registered Keywords - Box system, maternal health, Antenatal care, skilled delivery, postnatal care, cluster randomized controlled trial, Ethiopia

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