Maternal Newborn Health Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNICHD Global Network for Women's and Children's Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Participant-level
Opt out of consent to include data in the study
Trial population
All pregnant women meeting participant-level criteria and the infant(s) from their pregnancy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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 interventionThere 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.
Treatment groups
950,000 Participants
are divided into 2 treatment groupsGroup A: Pregnant women1 intervention
Group B: Male and Female Infants1 intervention
Trial outcomes
Primary outcomes
1
Maternal mortality rate
Maternal mortality rate by site and cluster
Time frame
42 days post delivery2
Stillbirth rate
Stillbirth rate by site and cluster
Time frame
Delivery3
Early neonatal mortality rate
ENM by site and by cluster
Time frame
28 days post deliverySecondary outcomes
1
Cause of maternal death at less than or equal to 42 days
Data collected by site and by cluster
Time frame
42 days post delivery2
Cause of neonatal death at less than or equal to 28 days
Data collected by site and by cluster
Time frame
28 days post delivery3
Prevalence of COVID-19 antibody positive results during pregnancy
Data collected by site and by cluster
Time frame
At 12-14 week antenatal care visit, at delivery or 14 days after4
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
Time frame
At delivery, 7 days post delivery and 28 days post deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov