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NCT Number: NCT01073475

Maternal Newborn Health Registry

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

ICDDRB, Dhaka, Bangladesh

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other

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.

Primary outcomes

  1. Maternal mortality rate

    Time frame: 42 days post delivery

    Maternal mortality rate by site and cluster

  2. Stillbirth rate

    Time frame: Delivery

    Stillbirth rate by site and cluster

  3. Early neonatal mortality rate

    Time frame: 28 days post delivery

    ENM by site and by cluster

Secondary outcomes

  1. Cause of maternal death at less than or equal to 42 days

    Time frame: 42 days post delivery

    Data collected by site and by cluster

  2. Cause of neonatal death at less than or equal to 28 days

    Time frame: 28 days post delivery

    Data collected by site and by cluster

  3. Prevalence of COVID-19 antibody positive results during pregnancy

    Time frame: At 12-14 week antenatal care visit, at delivery or 14 days after

    Data collected by site and by cluster

  4. 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

    Time frame: At delivery, 7 days post delivery and 28 days post delivery

    Data collected by site and by cluster

  5. Maternal outcomes (rate of infection, timing of infection, types of symptoms, death, cause of death) associated with COVID-19 positivity

    Time frame: At delivery, 42 days post delivery

    Data collected by site and by cluster

  6. Knowledge, attitudes, and practices of pregnant women related to COVID-19 infection during pregnancy

    Time frame: At the 12-14 week Antenatal Care visit

    Data collected by site and by cluster

  7. Peri-partum and postpartum depression

    Time frame: At delivery and 6 weeks post-partum

    Data collected by site and by cluster

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth McClure, PHD

CONTACT

[email protected]

919-316-3773

Marion Koso-Thomas, MD

CONTACT

[email protected]

301-435-6873

Sponsors and collaborators

Lead sponsor

NICHD Global Network for Women's and Children's Health

Network

Registry information

Official study title

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

Acronym: MNH

Important dates

Study start
2008
Primary completion
2030
Study completion
2030
First posted
Feb 23, 2010
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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