Pregnancy Outcome Trends in Low-resource Geographic Areas
Conditions
Keywords
Pregnancy, Maternal mortality, Neonatal mortality, Stillbirth, Maternal Cause of Death, Neonatal Cause of Death
Brief summary
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
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.
Interventions
OTHERThere 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.
Sponsors
NICHD Global Network for Women's and Children's Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal mortality rate | 42 days post delivery | Maternal mortality rate by site and cluster |
| Stillbirth rate | Delivery | Stillbirth rate by site and cluster |
| Early neonatal mortality rate | 28 days post delivery | ENM by site and by cluster |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cause of maternal death at less than or equal to 42 days | 42 days post delivery | Data collected by site and by cluster |
| Cause of neonatal death at less than or equal to 28 days | 28 days post delivery | Data collected by site and by cluster |
| Prevalence of COVID-19 antibody positive results during pregnancy | At 12-14 week antenatal care visit, at delivery or 14 days after | Data collected by site and by cluster |
| 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 | At delivery, 7 days post delivery and 28 days post delivery | Data collected by site and by cluster |
| Maternal outcomes (rate of infection, timing of infection, types of symptoms, death, cause of death) associated with COVID-19 positivity | At delivery, 42 days post delivery | Data collected by site and by cluster |
| Knowledge, attitudes, and practices of pregnant women related to COVID-19 infection during pregnancy | At the 12-14 week Antenatal Care visit | Data collected by site and by cluster |
| Peri-partum and postpartum depression | At delivery and 6 weeks post-partum | Data collected by site and by cluster |
Countries
Bangladesh, Democratic Republic of the Congo, Guatemala, India, Pakistan, United States, Zambia
Contacts
CONTACTMarion Koso-Thomas, MD
CONTACTElizabeth McClure, PHD
STUDY_DIRECTORMarion Koso-Thomas, MD
Center for Research for Mothers and Children (NICHD)
Outcome results
None listed