Clinical Research Directory

A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia

GESTA-SCORE is a prospective, randomized clinical trial designed to evaluate whether an early, personalized cardiovascular prevention strategy can achieve a clinically meaningful 6 mmHg reduction in systolic blood pressure at one year postpartum compared with guideline-based standard care in women with preeclampsia. Women with preeclampsia will be randomly assigned in a 1:1 ratio to one of two groups. The Intervention group will receive a structured cardiovascular prevention program based on early identification of cardiovascular risk factors, personalized clinical assessment, digital health monitoring and targeted preventive interventions. The Standard care group will receive postpartum care, including blood pressure assessment, antihypertensive treatment when indicated, cardiovascular risk management and clinical follow-up, in accordance with current clinical practice guidelines. All participants will receive appropriate medical care, and no clinically indicated treatment will be withheld. The study will also include two non-randomized observational comparison cohorts: women with other adverse pregnancy outcomes (APOs), such as gestational diabetes, preterm birth or fetal growth restriction, and women without APOs. These cohorts will help researchers understand differences in blood pressure evolution and cardiovascular recovery during the first year after childbirth. Participants will undergo an initial cardiovascular assessment during the first six weeks postpartum, followed by scheduled assessments at 3, 6 and 12 months after delivery. Blood pressure will be measured at each assessment using a validated automated upper-arm device and a standardized protocol. After five minutes of seated rest, three consecutive measurements will be obtained, approximately one minute apart. The average of the second and third measurements will be used as the blood pressure value for each assessment. The primary outcome will be mean systolic blood pressure at 12 months postpartum, comparing the Intervention and Standard care groups and adjusting for baseline systolic blood pressure measured during the first six weeks postpartum. The study is designed to detect a between-group difference of 6 mmHg. Secondary objectives include evaluating hypertension, cardiometabolic and kidney health, lifestyle changes and differences in postpartum cardiovascular recovery between women with preeclampsia, other APOs and pregnancies without APOs. GESTA-SCORE aims to establish whether early, personalized cardiovascular prevention can improve blood pressure control beyond current guideline-based care and contribute to more effective cardiovascular prevention after pregnancy.

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)

The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations \[MCMs\], small for gestational age \[SGA\]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.

A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes

United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE) and other adverse pregnancy outcomes (APOs). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with APOs to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants.

The Bone and hEArt Health Consequences of Ovarian agiNg (BEACON) Study

Ovarian aging is a major driver of a woman's long-term health and disease risk. In particular, the rapid decline in the ovarian reserve that occurs with the menopause transition is linked to a striking increase in the risk for both cardiometabolic disease and osteoporosis. A growing body of evidence has demonstrated that earlier age at menopause further exacerbates this risk for ischemic stroke, heart disease, and non-traumatic osteoporotic fracture. Thus, the identification of factors that accelerate ovarian aging is likely to lead to increased incidence and earlier onset of these conditions. Adverse pregnancy outcomes (APO) such as gestational diabetes, hypertensive disorders of pregnancy, and stillbirth, are major pathophysiological states that have the potential to accelerate depletion of the ovarian reserve due to the chronic inflammatory state, oxidative stress, and epigenetics changes that ensue. This proposal seeks to determine if APOs impact the ovarian aging trajectory and subsequent cardiometabolic and musculoskeletal health outcomes. Our central hypothesis is that APOs will accelerate ovarian aging, resulting in greater incidence and earlier onset of cardiometabolic disease and musculoskeletal decline. This hypothesis will be tested by accomplishing three aims designed to: 1) define the trajectory of ovarian aging and the impact of APOs on indicators of ovarian aging over time; 2) correlate the ovarian aging trajectory with the development of cardiometabolic risk; and 3) determine the association of ovarian aging biomarker trajectory on musculoskeletal health. To accomplish these aims we will capitalize on a subset of participants from the large, multisite nuMoM2b cohort that has been followed for fifteen years since the time of their first pregnancy. This project, the Bone and hEArt health Consequences of Ovarian agiNg (BEACON) Study, will utilize the extensive health, behavior, psychosocial and pregnancy data in this cohort, paired with biospecimens from their initial pregnancy and follow-up visits (3-7 \& 7-12 years after pregnancy), as well as data and specimens collected on participants completing an additional study visit. This proposal has the unique opportunity to provide longitudinal insight into the role of APOs in ovarian aging. If APOs are shown to accelerate ovarian aging, this mechanism may contribute to earlier onset of vascular dysfunction, metabolic disease, and musculoskeletal decline that would highlight the need for revised risk stratification for women with APOs, earlier screening (e.g., bone density, blood pressure \& lipids), and the development of targeted prevention strategies. Moreover, these findings could identify critical windows for intervention and reveal novel targets for earlier and more effective therapeutic strategies.

APOs Associated With Respiratory Viral Infections Before and During Early Pregnancy

Adverse pregnancy outcomes (APOs) are a collection of conditions that have short-term and long-term effects of complications related to pregnancy and childbirth on pregnant women and their fetuses, including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, large for gestational age, among others. Nearly 30% of all women experience an adverse pregnancy outcome during their reproductive years. Although, respiratory viral infections with epidemic and pandemic potential pose an omnipresent threat to public health, research focusing specifically on the maternal-infant population remains relatively scarce. Studies conducted in USA found that among pregnant women infected with influenza, the proportion of those with gestational hypertension or diabetes was higher than in pregnant women without influenza infection (13.9% vs. 11.1%). Research on the impact of respiratory viral infections on perinatal outcomes in China is limited, and we aim to establish of a large-scale, retroprospective maternal-child cohorts. This cohort study will systematically collect longitudinal data (e.g., detailed clinical history, timing of infection/vaccination, complication of pregnancy, and APOs) to assess the risk of respiratory viral infections to APOs, as well as facilitate multidisciplinary research.

Tailored Resistance Training After Adverse Pregnancy Outcomes

Approximately 7-10 postpartum people with recent adverse pregnancy outcomes (APOs: preeclampsia, gestational diabetes, hypertensive disorders of pregnancy, fetal growth restriction or low birth weight baby, or preterm birth) will be invited to complete 4 weeks of a resistance training intervention, including associated incentives, communication, and marketing materials.

JiGenerations Health Cohort Study：Parental Exposure and Intergenerational Health in China

The growing recognition of maternal health's impact on offspring necessitates large-scale prospective cohort studies spanning the maternal-child life cycle. This study establishes a family-centered birth cohort of 100,000 Chinese participants, tracking from preconception through offspring adolescence to investigate early-life health trajectories and intergenerational transmission of diseases, health status, and psychological-behavioral patterns. Data collection includes biospecimens (placenta, cord blood, breast milk, blood, urine, feces) and multi-omics analysis (genomic, proteomic, metabolomic, microbiomic), alongside clinical information from preconception, pregnancy, birth through childhood (0-14 years). The cohort covers 24 stratified sites across China, incorporating real-time environmental monitoring (air pollution, meteorological data) and sociogeographic factors. Targeting reproductive-age couples (18-45 years) and their offspring, the study addresses multigenerational health linkages, urban-rural disparities, and regional diversity from 2025 to 2039. By integrating genetic, environmental and lifestyle data, this research will identify critical intervention windows and mechanisms for chronic disease transmission across generations, supporting China's "Healthy China" initiative and developing targeted strategies for population health and aging.

Lifestyle, Education, Activity, Nutrition (LEAN) Into Pregnancy

The goal of this randomized controlled clinical trial is to determine if healthy lifestyle education can help improve cardiovascular health and reduce pregnancy complications in women during the preconception period or early pregnancy. The main aims include: 1. Determine the feasibility and acceptability of the LEAN into pregnancy study. 2. Determine the impact of healthy lifestyle education on Life's Essential 8 cardiovascular health score. 3. Determine the impact of health lifestyle education on adverse pregnancy outcomes, specifically gestational diabetes and preeclampsia. A total of 200 participants will be randomly assigned to receive healthy lifestyle education in addition to routine care, or routine care alone. Participants will be asked to participate in the following activities: * Blood draws to test hemoglobin A1c and lipids * Surveys about diet, physical activity, sleep, and tobacco use * Gaples Nutritional Education Modules (if applicable)

Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial

This is a multicentre, parallel-group, open-label, pragmatic, randomised-control trial of early lifestyle intervention versus routine prenatal care by random allocation (1:1) in women with early abnormal glucose metabolism (EAGM) to compare the incidence of large-gestational age and preterm birth between two groups. The investigators aim to assess the effectiveness of early lifestyle interventions and to provide evidence for the optimal standard management for Chinese women with EAGM.