Maternal Newborn Health Registry (MNH)
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ClinicalTrials.gov Identifier: NCT01073475 |
Recruitment Status :
Recruiting
First Posted : February 23, 2010
Last Update Posted : November 19, 2021
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Condition or disease | Intervention/treatment |
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Pregnancy Outcome Trends in Low-resource Geographic Areas | 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. |
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.
Study Type : | Observational |
Estimated Enrollment : | 950000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Global Network for Women's and Children's Health Research Maternal Newborn Health Registry |
Study Start Date : | May 2008 |
Estimated Primary Completion Date : | May 2023 |
Estimated Study Completion Date : | May 2023 |
Group/Cohort | Intervention/treatment |
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Pregnant women
Pregnant women in the MNH cluster
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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.
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
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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.
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. |
- Maternal mortality rate [ Time Frame: 42 days post delivery ]Maternal mortality rate by site and cluster
- Stillbirth rate [ Time Frame: Delivery ]Stillbirth rate by site and cluster
- Early neonatal mortality rate [ Time Frame: 28 days post delivery ]ENM by site and by cluster
- 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
- 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
- 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
- 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
- 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
- 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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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Community-level
- Appropriate for long-term registry data collection and the conduct of ongoing Global Network research
- At least 300 deliveries per year
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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:
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Participant-level
- Opt out of consent to include data in the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073475
Contact: Marion Koso-Thomas, MD | 301-435-6873 | marion.koso-thomas@nih.gov | |
Contact: Elizabeth McClure, PHD | 919-316-3773 | mcclure@rti.org |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35233 | |
Contact: Waldemar A. Carlo, MD 205-934-4680 Wcarlo@PEDS.UAB.EDU | |
Principal Investigator: Waldemar A. Carlo, MD | |
United States, Colorado | |
University of Colorado Denver | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Nancy Krebs, MD Nancy.krebs@cuanschutz.edu | |
Sub-Investigator: Nancy Krebs, MD | |
United States, Indiana | |
Indiana University School of Medicine | Recruiting |
Indianapolis, Indiana, United States, 46202-5119 | |
Contact: Ed Liechty, MD 317-274-4715 eliecht@iu.edu | |
Principal Investigator: Ed Liechty, MD | |
United States, Massachusetts | |
Boston University | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Patricia L. Hibberd, MD, PhD 617-636-2431 plh0@bu.edu | |
Principal Investigator: Patricia L. Hibberd, MD, PhD | |
United States, New York | |
Columbia University | Recruiting |
New York, New York, United States, 10032 | |
Contact: Robert Goldenberg, MD 215-762-2014 rlg88@cumc.columbia.edu | |
Principal Investigator: Robert Goldenberg, MD | |
United States, North Carolina | |
University of North Carolina | Recruiting |
Chapel Hill, North Carolina, United States, 27510 | |
Contact: Carl Bose, MD 984-974-7849 carl_bose@med.unc.edu | |
Principal Investigator: Carl Bose, MD | |
United States, Pennsylvania | |
Thomas Jefferson University | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Richard J. Derman, MD, MPH 302-733-3350 Richard.Derman@jefferson.edu | |
Principal Investigator: Richard J. Derman, MD, MPH | |
United States, Virginia | |
University of Virgina | Not yet recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Principal Investigator 434-924-5621 wap3g@virginia.edu | |
Principal Investigator: William A. Petri, MD | |
Bangladesh | |
ICDDRB | Not yet recruiting |
Dhaka, Bangladesh, 1212 | |
Contact: Site Principal Investigator rhaque@icddrb.org | |
Principal Investigator: Rashidul Haque, MD | |
Congo, The Democratic Republic of the | |
Kinshasa School of Public Health | Recruiting |
Kinshasa, Congo, The Democratic Republic of the | |
Contact: Antoinette Tshefu, MD, MPH, PhD +243 810 156 910 antotshe@yahoo.com | |
Principal Investigator: Antoinette Tshefu, MD, MPH, PhD | |
Guatemala | |
Institute for Nutrition of Central America and Panama (INCAP) | Recruiting |
Guatemala City, Guatemala, 01011 | |
Contact: Manolo Mazariegos, MD mmazariegos@incap.int | |
Principal Investigator: Manolo Mazariegos, MD | |
India | |
KLE Academy of Higher Education and Research | Recruiting |
Belgaum, Karnataka, India | |
Contact: Shivaprasad S. Goudar, MD, MHPE sgoudar@jnmc.edu | |
Principal Investigator: Shivaprasad S. Goudar, MD, mhpe | |
Lata Medical Research Foundation | Recruiting |
Nagpur, India | |
Contact: Archana Patel, MD, DNB, MSCE 91-98 2315 4463 dr_apatel@yahoo.com | |
Principal Investigator: Archana Patel, MD, DNB, MSCE | |
Kenya | |
Moi University School of Medicine | Recruiting |
Eldoret, Kenya | |
Contact: Fabian Esamai, MMed, PhD +254 733 836 410 fesamai2007@gmail.com | |
Principal Investigator: Fabian Esamai, MMed, PhD | |
Pakistan | |
The Aga Khan University | Recruiting |
Karachi, Pakistan, 74800 | |
Contact: Sarah Saleem, MD 92-213-486-4819 Sarah.saleem@aku.edu | |
Principal Investigator: Sarah Saleem, MD | |
Zambia | |
University Teaching Hospital | Recruiting |
Lusaka, Zambia | |
Contact: Elwyn Chomba, MBChB,DCH,MRCP +260 211 252 094 echomba@zamnet.zm | |
Principal Investigator: Elwyn Chomba, MBChB,DCH,MRCP |
Study Director: | Marion Koso-Thomas, MD | Center for Research for Mothers and Children (NICHD) |
Documents provided by NICHD Global Network for Women's and Children's Health:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | NICHD Global Network for Women's and Children's Health |
ClinicalTrials.gov Identifier: | NCT01073475 |
Other Study ID Numbers: |
CP MNH |
First Posted: | February 23, 2010 Key Record Dates |
Last Update Posted: | November 19, 2021 |
Last Verified: | November 2021 |
Pregnancy Maternal mortality Neonatal mortality |
Stillbirth Maternal Cause of Death Neonatal Cause of Death |