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Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Pregnant women 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.
    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.
Male and Female Infants 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.
    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.

Recruiting Locations

Boston University
Boston, Massachusetts 02115
Contact:
Patricia L. Hibberd, MD, PhD
617-636-2431
plh0@bu.edu

More Details

Status
Recruiting
Sponsor
NICHD Global Network for Women's and Children's Health

Study Contact

Marion Koso-Thomas, MD
301-435-6873
marion.koso-thomas@nih.gov

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.