Clinical Studies for Obstetrics & Gynecology

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Title: A Pilot Study To Assess The Effect Of Antepartum Perineal Massage Using A Pelvic Wand On Labor Agency And Pelvic Health
Brief Title: Perineal Massage Intervention
Brief Summary:
For info regarding 2025P000062 please contact Sarah Little at slittl10@bidmc.harvard.edu
 
Title: Infant Vaccine Biorepository
Brief Title: Infant Vaccine Biorepository
Brief Summary: The Infant Vaccine Biorepository is an observational study and the purpose is to better understand how long infant immune protection transferred through the placenta (from mother to baby) after maternal infection or vaccination lasts. We will research infections like influenza (the flu), pertussis (Whooping Cough), and SARS-CoV-2 (COVID-19), and others. You will be asked to collect a blood sample from your baby at home at 3-5 months-old, 6-8 months-old, and 9-12 months-old, using an investigational device for blood collection. The device will collect blood from the smallest blood vessels (the capillaries). The consenting parent will also have the option to test the device. Participation in this study will last until your baby is 1 year old. Compensation for participation is included.
For info regarding 2022P000765 please contact Dr. Ai-ris Collier at CVVRtrials@bidmc.harvard.edu
 
Title: Mpox Tissue and Data Repository
Brief Title: Mpox Tissue and Data Repository
Brief Summary: The purpose of this study is to collect samples and clinical information for storage in a repository from individuals with a suspected or confirmed diagnosis of Monkeypox, individuals who recovered from Monkeypox, and individuals who received or plan to receive a vaccine against Monkeypox.
For info regarding 2022P000577 please contact Center for Virology & Vaccine Research at 617-735-4610 or CVVRtrials@bidmc.harvard.edu
 
Title: Miracle of life study: Observational study of pregnant women to validate biomarkers of pregnancy complication risk
Brief Title: MIRACLE of LIFE Study
Brief Summary: The primary objective of this study is to clinically verify and validate Mirvies cfRNA-based classifiers that predict the risk of a woman developing complications including preeclampsia, preterm birth, and gestational diabetes during her pregnancy. The putative classifiers were identified in a whole transcriptome discovery study of over 3,000 women completed in 2020. Subjects must be pregnant with a singleton pregnancy between 18-22 weeks gestation at time of enrollment to be eligible for this study.
For info regarding 2022P000224 please contact Eleanor Schonberg at 617-667-0881 or pregnancystudy@bidmc.harvard.edu
 
Title: Measures of maternal immune function in fresh and stored blood samples
Brief Title: Immune response in fresh and stored blood
Brief Summary: This prospective cohort study seeks to determine whether immune function throughout pregnancy can be measured at the time of blood collection and also on blood that has been stored. The samples are analyzed using Treg assays on fresh peripheral blood samples and cytokine assays on stored plasma. Results will be compared to determine how measures of immune function from stored samples correlated to results from fresh samples. Participants must be pregnant with plans to deliver at BIDMC.
For info regarding 2021P000926 please contact Anna Modest, PhD MPH at ammodest@bidmc.harvard.edu
 
Title: COVID-19 and Other Respiratory Pathogens Biorepository
Brief Title: COVID-19 and Other Respiratory Pathogens Biorepository
Brief Summary: The purpose of this study is to establish a biorepository of specimens and clinical data from potential, confirmed, or convalescent Coronavirus disease 2019 (COVID-19) cases and from those vaccinated with a COVID-19 vaccine. The study recruits and enrolls special populations including individuals who are pregnant or lactating and who are receiving vaccines against COVID-19 infection.
For info regarding 2020P000361 please contact Ai-Ris Collier, MD at (617) 735-4610 or CVVRtrials@bidmc.harvard.edu
 
Title: Randomized controlled trial of panniculus retraction methods for cesarean delivery
Brief Title: Panniculus retraction of cesarean delivery
Brief Summary: This prospective, open-label, randomized-controlled trial is designed to evaluate the use of the Traxi panniculus retractor-- a commercially available Class I FDA-exempt device will improve surgical outcomes, cardiopulmonary function, and provider/patient satisfaction in morbidly obese women undergoing cesarean delivery.
For info regarding 2018P000369 please contact Ai-ris Collier at 617-667-7000 or acollier@bidmc.harvard.edu