Maternal Newborn Health Registry

Study Overview
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Brief Summary
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The primary purpose of this population-based study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based data on stillbirths, neonatal and maternal mortality.

Detailed Description
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The purpose of the Global Network for Women's and Children's Health Research is to develop and test feasible, sustainable interventions to improve the outcome of women and children and to develop research capacity in resource-poor settings. Because most of the sites have weak health care systems, unacceptably high rates of maternal and neonatal mortality and lack birth and death registries, they lack precise data on outcomes and measures of care. Information from a vital registry system will allow the Global Network to document maternal and neonatal mortality, design trials to address the major causes of poor outcome, assess the outcome of our interventions, and ultimately disseminate the results as the basis of public health policy. A sub-study to the Maternal Newborn Health Registry will be conducted to understand the prevalence of COVID-19 among pregnant women, the association between COVID-19 and pregnancy outcomes, and the Knowledge, Attitudes, and Practices of pregnant women related to COVID-19 and its prevention during pregnancy. Women who consent to participation in the MNHR COVID sub-study will provide a blood specimen at or near delivery to be tested for COVID-19 antibodies. Four Global Network sites (Guatemala, Bangladesh, Nagpur India and Pakistan) will also collect and analyze blood specimen from participants during antenatal care visits.

Official Title
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Global Network for Women's and Children's Health Research Maternal Newborn Health Registry

Conditions
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Pregnancy Outcome Trends in Low-resource Geographic Areas

Intervention / Treatment
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* Other: There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-level Appropriate for long-term registry data collection and the conduct of ongoing Global Network research At least 300 deliveries per year Participant-level Pregnant women intending to deliver within study cluster Women who deliver within the study cluster Women who reside in the community but are transferred for care at delivery Exclusion Criteria: Participant-level Opt out of consent to include data in the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>Pregnant women in the MNH cluster | Other: There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery.<br>* There is no intervention associated with the parent MNHR study For the MNHR COVID sub-study, each woman will be asked to provide a blood specimen of approximately 3-5 cc at or near delivery (at delivery or 14 days after) to be tested for COVID-19 antibodies. The person collecting the specimen will be a trained member of the registry staff. The ZEUS ELISA SARS-CoV-2 IgG Test System will be used and run at each site. RTI International will provide central quality support of the analyses.<br>|
| Male and Female Infants<br>Male and Female Infants delivered in the clusters | Other: There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery.<br>* There is no intervention associated with the parent MNHR study For the MNHR COVID sub-study, each woman will be asked to provide a blood specimen of approximately 3-5 cc at or near delivery (at delivery or 14 days after) to be tested for COVID-19 antibodies. The person collecting the specimen will be a trained member of the registry staff. The ZEUS ELISA SARS-CoV-2 IgG Test System will be used and run at each site. RTI International will provide central quality support of the analyses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal mortality rate | Maternal mortality rate by site and cluster | 42 days post delivery | 
| Stillbirth rate | Stillbirth rate by site and cluster | Delivery | 
| Early neonatal mortality rate | ENM by site and by cluster | 28 days post delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cause of maternal death at less than or equal to 42 days | Data collected by site and by cluster | 42 days post delivery | 
| Cause of neonatal death at less than or equal to 28 days | Data collected by site and by cluster | 28 days post delivery | 
| Prevalence of COVID-19 antibody positive results during pregnancy | Data collected by site and by cluster | At 12-14 week antenatal care visit, at delivery or 14 days after | 
| Fetal/neonatal outcomes (spontaneous abortion, stillbirth, birth weight (g), and fetal growth restriction, early (7-day) and late (28-day) neonatal death, cause of death, congenital infections, and malformations) associated with COVID-19 positivity | Data collected by site and by cluster | At delivery, 7 days post delivery and 28 days post delivery | 
| Maternal outcomes (rate of infection, timing of infection, types of symptoms, death, cause of death) associated with COVID-19 positivity | Data collected by site and by cluster | At delivery, 42 days post delivery | 
| Knowledge, attitudes, and practices of pregnant women related to COVID-19 infection during pregnancy | Data collected by site and by cluster | At the 12-14 week Antenatal Care visit | 
| Peri-partum and postpartum depression | Data collected by site and by cluster | At delivery and 6 weeks post-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal mortality, Pregnancy, Maternal mortality, Stillbirth, Maternal Cause of Death, Neonatal Cause of Death