Clinical trial NCT01073475: Maternal Newborn Health Registry
Official title: Global Network for Women's and Children's Health Research Maternal Newborn Health Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Outcome Trends in Low-resource Geographic Areas
Keywords: Pregnancy
Maternal mortality
Neonatal mortality
Stillbirth
Maternal Cause of Death
Neonatal Cause of Death
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
First posted: 2010-02-23
Enrollment: 950000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women meeting participant-level criteria and the infant(s) from their pregnancy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal mortality rate
timeFrame: 42 days post delivery
measure: Stillbirth rate
timeFrame: Delivery
measure: Early neonatal mortality rate
timeFrame: 28 days post delivery
Secondary outcomes:
measure: Cause of maternal death at less than or equal to 42 days
timeFrame: 42 days post delivery
measure: Cause of neonatal death at less than or equal to 28 days
timeFrame: 28 days post delivery
measure: Prevalence of COVID-19 antibody positive results during pregnancy
timeFrame: At 12-14 week antenatal care visit, at delivery or 14 days after
measure: 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
timeFrame: At delivery, 7 days post delivery and 28 days post delivery
measure: Maternal outcomes (rate of infection, timing of infection, types of symptoms, death, cause of death) associated with COVID-19 positivity
timeFrame: At delivery, 42 days post delivery
measure: Knowledge, attitudes, and practices of pregnant women related to COVID-19 infection during pregnancy
timeFrame: At the 12-14 week Antenatal Care visit
measure: Peri-partum and postpartum depression
timeFrame: At delivery and 6 weeks post-partum
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virgina
state: Virginia
city: Dhaka
country: Bangladesh
facility: ICDDRB
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kinshasa School of Public Health
city: Guatemala City
country: Guatemala
facility: Institute for Nutrition of Central America and Panama (INCAP)
city: Belgaum
country: India
facility: KLE Academy of Higher Education and Research
state: Karnataka
city: Nagpur
country: India
facility: Lata Medical Research Foundation
city: Karachi
country: Pakistan
facility: The Aga Khan University
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: Center for Research for Mothers and Children (NICHD)
name: Marion Koso-Thomas, MD
role: STUDY_DIRECTOR
References:
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