Maternal Newborn Health Registry

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Maternal mortality rate [Срок оценки: 42 days post delivery]
• Stillbirth rate [Срок оценки: Delivery]
• Early neonatal mortality rate [Срок оценки: 28 days post delivery]

Вторичные конечные точки (7)

• Cause of maternal death at less than or equal to 42 days [Срок оценки: 42 days post delivery]
• Cause of neonatal death at less than or equal to 28 days [Срок оценки: 28 days post delivery]
• Prevalence of COVID-19 antibody positive results during pregnancy [Срок оценки: At 12-14 week antenatal care visit, at delivery or 14 days after]
• 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 [Срок оценки: At delivery, 7 days post delivery and 28 days post delivery]
• Maternal outcomes (rate of infection, timing of infection, types of symptoms, death, cause of death) associated with COVID-19 positivity [Срок оценки: At delivery, 42 days post delivery]
• Knowledge, attitudes, and practices of pregnant women related to COVID-19 infection during pregnancy [Срок оценки: At the 12-14 week Antenatal Care visit]
• Peri-partum and postpartum depression [Срок оценки: At delivery and 6 weeks post-partum]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Participant-level

• Opt out of consent to include data in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 8 центров

• University of Alabama at Birmingham — Birmingham
• University of Colorado Denver — Aurora
• Indiana University School of Medicine — Indianapolis
• Boston University — Boston
• Columbia University — New York
• University of North Carolina — Chapel Hill
• Thomas Jefferson University — Philadelphia
• University of Virgina — Charlottesville

Индия · 2 центра

• Lata Medical Research Foundation — Nagpur
• KLE Academy of Higher Education and Research — Belagavi

Bangladesh · 1 центр

• ICDDRB — Dhaka

Democratic Republic of the Congo · 1 центр

• Kinshasa School of Public Health — Kinshasa

Guatemala · 1 центр

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

Пакистан · 1 центр

• The Aga Khan University — Karachi

Zambia · 1 центр

• University Teaching Hospital — Lusaka

Публикации

• 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. PMID 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. PMID 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 child PMID 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- PMID 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. PMID 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 D PMID 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 PMID 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. PMID 33334343

Идентификаторы

NCT: NCT01073475 · CP MNH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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