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Pregnancy Outcome Trends in Low-resource Geographic AreasMNHNCT01073475

Maternal Newborn Health Registry

An observational study of Pregnancy Outcome Trends in Low-resource Geographic Areas, run by NICHD Global Network for Women's and Children's Health at 15 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
How many people
950,000 participants
Where
15 sitesin 7 countries
Study dates
May 2008to May 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: All pregnant women meeting participant-level criteria and the infant(s) from their pregnancy.

Who may be able to join

  • 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

Who cannot join

  • Participant-level
  • Opt out of consent to include data in the study

Trial locations and contacts

15 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Marion Koso-Thomas, MD contact

301-435-6873

marion.koso-thomas@nih.gov

Elizabeth McClure, PHD contact

919-316-3773

mcclure@rti.org

15 sites in 7 countries

United States8 sites, 8 recruiting

  • University of Colorado Denver

    Aurora, Colorado, 80045

    Nancy Krebs, MD, Nancy.krebs@cuanschutz.edu

    Nancy Krebs, MD

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Waldemar A. Carlo, MD, 205-934-4680, Wcarlo@PEDS.UAB.EDU

    Waldemar A. Carlo, MD

    Recruiting

  • Boston University

    Boston, Massachusetts, 02115

    Patricia L. Hibberd, MD, PhD, 617-636-2431, plh0@bu.edu

    Patricia L. Hibberd, MD, PhD

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27510

    Carl Bose, MD, 984-974-7849, carl_bose@med.unc.edu

    Carl Bose, MD

    Recruiting

  • University of Virgina

    Charlottesville, Virginia, 22908

    Principal Investigator, 434-924-5621, wap3g@virginia.edu

    William A. Petri, MD

    Recruiting

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202-5119

    Ed Liechty, MD, 317-274-4715, eliecht@iu.edu

    Ed Liechty, MD

    Recruiting

  • Columbia University

    New York, New York, 10032

    Robert Goldenberg, MD, 215-762-2014, rlg88@cumc.columbia.edu

    Robert Goldenberg, MD

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Richard J. Derman, MD, MPH, 302-733-3350, Richard.Derman@jefferson.edu

    Richard J. Derman, MD, MPH

    Recruiting

Other trials in United States

India2 sites, 2 recruiting

  • KLE Academy of Higher Education and Research

    Belagavi, Karnataka

    Shivaprasad S. Goudar, MD, MHPE, sgoudar@jnmc.edu

    Shivaprasad S. Goudar, MD, mhpe

    Recruiting

  • Lata Medical Research Foundation

    Nagpur, India

    Archana Patel, MD, DNB, MSCE, 91-98 2315 4463, dr_apatel@yahoo.com

    Archana Patel, MD, DNB, MSCE

    Recruiting

Other trials in India

Bangladesh1 site, 1 recruiting

  • ICDDRB

    Dhaka, 1212

    Site Principal Investigator, rhaque@icddrb.org

    Rashidul Haque, MD

    Recruiting

Other trials in Bangladesh

Democratic Republic of the Congo1 site, 1 recruiting

  • Kinshasa School of Public Health

    Kinshasa

    Antoinette Tshefu, MD, MPH, PhD, +243 810 156 910, antotshe@yahoo.com

    Antoinette Tshefu, MD, MPH, PhD

    Recruiting

Other trials in Democratic Republic of the Congo

Guatemala1 site, 1 recruiting

  • Institute for Nutrition of Central America and Panama (INCAP)

    Guatemala City, Departamento de Guatemala, 01011

    Manolo Mazariegos, MD, mmazariegos@incap.int

    Manolo Mazariegos, MD

    Recruiting

Other trials in Guatemala

Pakistan1 site, 1 recruiting

  • The Aga Khan University

    Karachi, Pakistan, 74800

    Sarah Saleem, MD, 92-213-486-4819, Sarah.saleem@aku.edu

    Sarah Saleem, MD

    Recruiting

Other trials in Pakistan

Zambia1 site, 1 recruiting

  • University Teaching Hospital

    Lusaka, Zambia

    Elwyn Chomba, MBChB,DCH,MRCP, +260 211 252 094, echomba@zamnet.zm

    Elwyn Chomba, MBChB,DCH,MRCP

    Recruiting

Other trials in Zambia

About this study

Official title: Global Network for Women's and Children's Health Research 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.

Read the 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.

Being tested
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.
Keywords
Pregnancy, Maternal mortality, Neonatal mortality, Stillbirth, Maternal Cause of Death, Neonatal Cause of Death
Medical subject headings
Maternal Death, Stillbirth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01073475
Study groupRoleWhat they receive
Pregnant womenPregnant women in the MNH cluster
Receives: 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.
Male and Female InfantsMale and Female Infants delivered in the clusters
Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal mortality rate

    Maternal mortality rate by site and cluster

    Measured: 42 days post delivery

  2. Stillbirth rate

    Stillbirth rate by site and cluster

    Measured: Delivery

  3. Early neonatal mortality rate

    ENM by site and by cluster

    Measured: 28 days post delivery

Secondary outcomes (7)

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

    Data collected by site and by cluster

    Measured: 42 days post delivery

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

    Data collected by site and by cluster

    Measured: 28 days post delivery

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

    Data collected by site and by cluster

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

  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

    Data collected by site and by cluster

    Measured: At delivery, 7 days post delivery and 28 days post delivery

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

    Data collected by site and by cluster

    Measured: At delivery, 42 days post delivery

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

    Data collected by site and by cluster

    Measured: At the 12-14 week Antenatal Care visit

  7. Peri-partum and postpartum depression

    Data collected by site and by cluster

    Measured: At delivery and 6 weeks post-partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2010 (estimated)
  2. Study startMay 2008
  3. Primary completionJan 2030 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
950,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01073475
Sponsor's protocol ID
CP MNH
Acronym
MNH
Status last verified
Jan 2026
First submitted
21 Feb 2010
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Austad KE, Rao SR, Hibberd PL, Patel AB. Trends and determinants of the use of episiotomy in a prospective population-based registry from central India. BMC Pregnancy Childbirth. 2024 Sep 12;24(1):598. doi: 10.1186/s12884-024-06762-y.

    PubMed 39267006

  • Switchenko N, Shukla V, Mwenechanya M, Chomba E, Patel A, Hibberd PL, Ambalavanan N, Figueroa L, Mazariegos M, Krebs NF, Goudar SS, Derman R, Esamai F, Liechty EA, Bucher S, Saleem S, Goldenberg RL, Lokangaka A, Tshefu A, Bose CL, Koso-Thomas M, Tan S, Nolen T, McClure EM, Carlo WA. Neonatal Respiratory Support Utilization in Low- and Middle-Income Countries: A Registry-Based Observational Study. Neonatology. 2024;121(1):116-124. doi: 10.1159/000534777. Epub 2023 Dec 4.

    PubMed 38048757

  • Figueroa L, Harrison M, Mazariegos M, Goudar S, Kavi A, Derman R, Patel A, Das P, Hibberd PL, Saleem S, Naqvi F, Goldenberg RL, Haque R, Billah SM, Petri WA Jr, McClure EM, Tan S, Krebs NF. Maternal and perinatal outcomes of women with vaginal birth after cesarean section compared to repeat cesarean birth in select South Asian and Latin American settings of the global network for women's and children's health research. Matern Health Neonatol Perinatol. 2023 Nov 1;9(1):13. doi: 10.1186/s40748-023-00169-x.

    PubMed 37908009

  • Patel A, Bann CM, Thorsten VR, Rao SR, Lokangaka A, Tshefu Kitoto A, Bauserman M, Figueroa L, Krebs NF, Esamai F, Bucher S, Saleem S, Goldenberg RL, Chomba E, Carlo WA, Goudar S, Derman R, Koso-Thomas M, McClure E, Hibberd PL. Can the date of last menstrual period be trusted in the first trimester? Comparisons of gestational age measures from a prospective cohort study in six low-income to middle-income countries. BMJ Open. 2023 Sep 20;13(9):e067470. doi: 10.1136/bmjopen-2022-067470.

    PubMed 37730415

  • Marete I, Ekhaguere O, Bann CM, Bucher SL, Nyongesa P, Patel AB, Hibberd PL, Saleem S, Goldenberg RL, Goudar SS, Derman RJ, Garces AL, Krebs NF, Chomba E, Carlo WA, Lokangaka A, Bauserman M, Koso-Thomas M, Moore JL, McClure EM, Esamai F. Regional trends in birth weight in low- and middle-income countries 2013-2018. Reprod Health. 2020 Dec 17;17(Suppl 3):176. doi: 10.1186/s12978-020-01026-2.

    PubMed 33334365

  • Patel AB, Bann CM, Garces AL, Krebs NF, Lokangaka A, Tshefu A, Bose CL, Saleem S, Goldenberg RL, Goudar SS, Derman RJ, Chomba E, Carlo WA, Esamai F, Liechty EA, Koso-Thomas M, McClure EM, Hibberd PL. Development of the Global Network for Women's and Children's Health Research's socioeconomic status index for use in the network's sites in low and lower middle-income countries. Reprod Health. 2020 Dec 17;17(Suppl 3):193. doi: 10.1186/s12978-020-01034-2.

    PubMed 33334359

  • Pusdekar YV, Patel AB, Kurhe KG, Bhargav SR, Thorsten V, Garces A, Goldenberg RL, Goudar SS, Saleem S, Esamai F, Chomba E, Bauserman M, Bose CL, Liechty EA, Krebs NF, Derman RJ, Carlo WA, Koso-Thomas M, Nolen TL, McClure EM, Hibberd PL. Rates and risk factors for preterm birth and low birthweight in the global network sites in six low- and low middle-income countries. Reprod Health. 2020 Dec 17;17(Suppl 3):187. doi: 10.1186/s12978-020-01029-z.

    PubMed 33334356

  • Bauserman M, Thorsten VR, Nolen TL, Patterson J, Lokangaka A, Tshefu A, Patel AB, Hibberd PL, Garces AL, Figueroa L, Krebs NF, Esamai F, Nyongesa P, Liechty EA, Carlo WA, Chomba E, Goudar SS, Kavi A, Derman RJ, Saleem S, Jessani S, Billah SM, Koso-Thomas M, McClure EM, Goldenberg RL, Bose C. Maternal mortality in six low and lower-middle income countries from 2010 to 2018: risk factors and trends. Reprod Health. 2020 Dec 17;17(Suppl 3):173. doi: 10.1186/s12978-020-00990-z.

    PubMed 33334343

  • Goudar SS, Goco N, Somannavar MS, Kavi A, Vernekar SS, Tshefu A, Chomba E, Garces AL, Saleem S, Naqvi F, Patel A, Esamai F, Bose CL, Carlo WA, Krebs NF, Hibberd PL, Liechty EA, Koso-Thomas M, Nolen TL, Moore J, Iyer P, McClure EM, Goldenberg RL, Derman RJ. Institutional deliveries and stillbirth and neonatal mortality in the Global Network's Maternal and Newborn Health Registry. Reprod Health. 2020 Dec 17;17(Suppl 3):179. doi: 10.1186/s12978-020-01001-x.

    PubMed 33334337

  • Patel AB, Simmons EM, Rao SR, Moore J, Nolen TL, Goldenberg RL, Goudar SS, Somannavar MS, Esamai F, Nyongesa P, Garces AL, Chomba E, Mwenechanya M, Saleem S, Naqvi F, Bauserman M, Bucher S, Krebs NF, Derman RJ, Carlo WA, Koso-ThomasMcClure MEM, Hibberd PL. Evaluating the effect of care around labor and delivery practices on early neonatal mortality in the Global Network's Maternal and Newborn Health Registry. Reprod Health. 2020 Nov 30;17(Suppl 2):156. doi: 10.1186/s12978-020-01010-w.

    PubMed 33256790

  • Bauserman M, Nowak K, Nolen TL, Patterson J, Lokangaka A, Tshefu A, Patel AB, Hibberd PL, Garces AL, Figueroa L, Krebs NF, Esamai F, Liechty EA, Carlo WA, Chomba E, Mwenechanya M, Goudar SS, Ramadurg U, Derman RJ, Saleem S, Jessani S, Koso-Thomas M, McClure EM, Goldenberg RL, Bose C. The relationship between birth intervals and adverse maternal and neonatal outcomes in six low and lower-middle income countries. Reprod Health. 2020 Nov 30;17(Suppl 2):157. doi: 10.1186/s12978-020-01008-4.

    PubMed 33256784

  • McClure EM, Saleem S, Goudar SS, Garces A, Whitworth R, Esamai F, Patel AB, Tikmani SS, Mwenechanya M, Chomba E, Lokangaka A, Bose CL, Bucher S, Liechty EA, Krebs NF, Yogesh Kumar S, Derman RJ, Hibberd PL, Carlo WA, Moore JL, Nolen TL, Koso-Thomas M, Goldenberg RL. Stillbirth 2010-2018: a prospective, population-based, multi-country study from the Global Network. Reprod Health. 2020 Nov 30;17(Suppl 2):146. doi: 10.1186/s12978-020-00991-y.

    PubMed 33256783

  • Saleem S, Naqvi F, McClure EM, Nowak KJ, Tikmani SS, Garces AL, Hibberd PL, Moore JL, Nolen TL, Goudar SS, Kumar Y, Esamai F, Marete I, Patel AB, Chomba E, Mwenechanya M, Bose CL, Liechty EA, Krebs NF, Derman RJ, Carlo WA, Tshefu A, Koso-Thomas M, Siddiqi S, Goldenberg RL. Neonatal deaths in infants born weighing >/= 2500 g in low and middle-income countries. Reprod Health. 2020 Nov 30;17(Suppl 2):158. doi: 10.1186/s12978-020-01013-7.

    PubMed 33256782

  • Dhaded SM, Somannavar MS, Moore JL, McClure EM, Vernekar SS, Yogeshkumar S, Kavi A, Ramadurg UY, Nolen TL, Goldenberg RL, Derman RJ, Goudar SS. Neonatal deaths in rural Karnataka, India 2014-2018: a prospective population-based observational study in a low-resource setting. Reprod Health. 2020 Nov 30;17(Suppl 2):161. doi: 10.1186/s12978-020-01014-6.

    PubMed 33256777

  • Figueroa L, Garces A, Hambidge KM, McClure EM, Moore J, Goldenberg R, Krebs NF. Prevalence of clinically-evident congenital anomalies in the Western highlands of Guatemala. Reprod Health. 2020 Nov 30;17(Suppl 2):153. doi: 10.1186/s12978-020-01007-5.

    PubMed 33256772

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy Outcome Trends in Low-resource Geographic Areas, run by NICHD Global Network for Women's and Children's Health at 15 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, India, Bangladesh, Democratic Republic of the Congo, Guatemala and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marion Koso-Thomas, MD (301-435-6873, marion.koso-thomas@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal mortality rate (time frame: 42 days post delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01073475, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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