Pregnant Women

Bipolar disorder (BD) is a serious mental illness that tends to run in families and affects behavior, thinking, emotions, social interactions, and work. It has characteristics like high prevalence, frequent recurrence, and early onset. Early recognition and diagnosis are challenging but important for better outcomes. This research aims to create a large, high-quality group of BD high-risk individuals by enrolling 400 participants over four years and following them intensively for ten years using an electronic mental health platform. The study will collect various types of data including clinical, genetic, cognitive, neuroimaging, sleep, EEG, eye movement, speech, facial expression, and movement to understand how biological, clinical, and environmental factors interact in BD onset. The study is observational and includes three groups: children aged 6 to 18 who have at least one parent with BD, children with atypical depression diagnosed by DSM-5 criteria, and healthy children matched by age and gender without psychiatric family history. Participants will be assessed yearly for four years, including brain scans and multiple follow-ups to track the development of mental illnesses, brain structure and function, cognitive function, sleep quality, quality of life, and genetic features. Participants will be involved in annual evaluations for four years, including clinical assessments and brain imaging. Researchers will monitor the differences in development among the three groups over time. The main outcomes focus on the prevalence of mental illness, brain development, and multi-modal feature changes. Secondary outcomes include cognitive function, sleep quality, quality of life, and genetic differences. This long-term follow-up aims to develop predictive models for BD onset and guide early, personalized interventions for those at high risk.

Young adults aged 25 to 39 who have cancer face unique challenges in coping, and their partners who provide care may feel burdened and less confident in their caregiving roles. Researchers are evaluating a brief psychotherapy intervention designed to improve how these young adults and their caregiving partners cope with cancer and maintain their relationships. This pilot study aims to test whether this intervention is feasible and acceptable in this specific group, providing important information for future larger studies. The intervention involves eight weekly virtual psychotherapy sessions lasting 45 to 60 minutes, delivered to young adults with cancer and their self-identified partners together. It is based on cognitive-behavioral therapy and couples-focused therapy principles tailored for young adults. A trained mental health practitioner will guide the sessions, which include teaching, practical exercises, and home practice. The study includes 10 young adults with cancer and their caregiving partners, totaling 20 participants. Participants will complete surveys before starting the intervention and again after finishing the eight sessions to measure feasibility and acceptability over approximately 14 weeks. They will also be invited to take part in optional interviews to share their experiences. This study is sponsored by Massachusetts General Hospital and does not include a control group or blinding. The total duration of involvement for participants is about three and a half months.

This research aims to observe the effects of Palynziq (pegvaliase) treatment in pregnant women with phenylketonuria (PKU) and on their babies exposed to pegvaliase during pregnancy and breastfeeding. The study is a Phase 4 observational trial that evaluates maternal, fetal, and infant outcomes related to pegvaliase exposure. It includes women diagnosed with PKU who were treated with pegvaliase from two weeks before their last menstrual period (LMP) or at any time during pregnancy. Participants are pregnant women prescribed pegvaliase by their healthcare provider who enroll through a centralized call center. The study collects data retrospectively from at least three months before the LMP, through pregnancy, and during the infant's first year of life. The timing and duration of pegvaliase exposure during pregnancy and breastfeeding, including each trimester, are recorded. Individual participation lasts up to about 21 months. During the study, information will be gathered from the participant's healthcare providers and the infant's doctors. Researchers will monitor pregnancy outcomes and infant development over ten years, focusing on pegvaliase exposure effects. The study also tracks serious adverse events and pegvaliase use during breastfeeding. This long-term monitoring aims to provide detailed data on maternal and infant health following pegvaliase exposure.

Researchers are exploring how giving pregnant individuals a choice among different nutrition and exercise programs affects their ability to stick to the program and maintain healthy pregnancy outcomes. The study focuses on preventing excessive gestational weight gain by comparing adherence to three lifestyle intervention strategies within the Nutrition and Exercise Lifestyle Intervention Program (NELIP). This research uses a pseudo-randomized design to examine if choice improves participation compared to no choice in pregnant individuals between 12 and 18 weeks of pregnancy with a single fetus. Participants are divided into two groups: one group chooses from three intervention strategies and the other group is matched to a choice participant and receives the same strategy without choice. The three strategies vary in timing of introducing nutrition and exercise components; either both simultaneously starting at 12-18 weeks, or nutrition first followed by exercise at 25 weeks, or exercise first followed by nutrition at 25 weeks. The exercise involves a supervised walking program with gradually increasing duration, and nutrition is based on a modified gestational diabetic meal plan tailored per participant. The full program continues until delivery, with final intervention measures between 34 and 36 weeks gestation. Participants will be monitored weekly for adherence using a point system, with additional assessments of satisfaction and health outcomes like weight gain, birth measurements, and pregnancy complications. Follow-up visits occur at birth and at 2, 6, and 12 months postpartum to track maternal and infant health. The study collects detailed data on nutrition, exercise, and pregnancy progress to understand how choice impacts adherence and outcomes over this extended timeline.

Pregnant women with aplastic anemia (AA), a rare blood disorder causing bone marrow failure and low blood counts, face serious risks including heavy bleeding, infections, and complications for their babies like preterm birth and restricted growth. This research aims to develop and validate a tool to predict adverse pregnancy outcomes in women with AA, helping guide early clinical decisions and improve health for mothers and infants. The study combines retrospective and prospective data collection across multiple centers to address the current lack of comprehensive data in this area. The study involves observing pregnant women diagnosed with AA either before or during their pregnancy. Researchers will gather baseline information and diagnostic data, then follow participants regularly through questionnaires, phone calls, video consultations, online platforms, and in-person visits. They will record treatments, other health conditions, and pregnancy outcomes, aiming to build a prediction model for adverse outcomes. Participants will be monitored from their first hospital visit during pregnancy until 42 days after delivery. Data collected includes clinical assessments and neonatal Apgar scores shortly after birth. The study will provide detailed information on the health and risks for mothers and babies affected by AA during pregnancy, helping improve care strategies. The total participation duration varies depending on the timing of enrollment and delivery.

Researchers are studying the use of two new surgical devices, the Karl Storz Curved and Straight Fetoscopes, to assist in minimally invasive in-utero surgeries. These devices help surgeons see inside the uterus during procedures to treat fetal conditions like twin-twin transfusion syndrome and other complex anomalies. The study aims to assess surgical outcomes, complications, and gestational age in patients treated with these scopes, helping to understand their potential benefits in fetal surgery. The curved fetoscope is designed for patients with an anterior placenta, while the straight fetoscope is used for those with a posterior placenta. Both scopes assist in fetoscopic laser photocoagulation, a procedure that seals abnormal blood vessels in the placenta using laser energy. This research is a non-randomized, single arm study where eligible patients undergo intrauterine procedures with either the curved or straight scopes based on placenta position. The study will collect data on the success of the procedures and related complications for descriptive analysis. Participants will be monitored through the procedure and follow-up until birth and shortly after. The study will evaluate outcomes such as the rate of completed fetoscopic procedures, fetal survival at birth, and various maternal and fetal complications. Researchers will also track gestational age at delivery, procedure length, and short-term neonatal health. The total study duration extends over several years to capture both immediate and longer-term results of using these devices in fetal surgery.

Researchers are evaluating a digital cognitive behavioral therapy (CBT) program combined with telephone coaching to address depressive symptoms during pregnancy. This randomized controlled trial compares the guided digitalized treatment program to a control group receiving digital education material about depression. The study focuses on pregnant women experiencing antenatal depression, aiming to assess the effectiveness of these digital interventions in improving mental health. Participants are randomly assigned to one of two groups. One group receives weekly internet-based CBT sessions with telephone coaching, while the other group is provided with psychoeducational digital materials about depression. The treatment period lasts 11 weeks after randomization, during which participants engage with their assigned interventions remotely. Throughout the study, participants will be assessed using several mental health questionnaires including the Edinburgh Postnatal Depression Scale (EPDS), General Anxiety Disorder 7-item scale (GAD-7), Beck Depression Inventory II (BDI-II), Social Phobia Inventory (SPIN), Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ), and Perceived Stress Scale (PSS). These assessments occur at the start of the study and 11 weeks later to measure changes in symptoms. The research team monitors participant progress and collects data to evaluate the interventions' impact on antenatal depression and related anxiety and stress symptoms.

Researchers are evaluating postpartum diabetes screening methods and cardiovascular health counseling for individuals who experienced gestational diabetes during pregnancy. The study compares immediate inpatient postpartum oral glucose tolerance testing (OGTT) before hospital discharge to the current standard outpatient OGTT performed 4-12 weeks after delivery. Additionally, the study explores patient perspectives on postpartum cardiovascular health counseling and risk reduction, including social and structural factors that affect health outcomes. This research is conducted to address the increased risk of type 2 diabetes and cardiovascular disease in this population and to improve postpartum care. The trial includes two study groups: one receiving an immediate inpatient 2-hour OGTT before discharge, and the other receiving the standard 4-12 week outpatient OGTT. Eligible participants are individuals aged 18 or older, diagnosed with gestational diabetes during pregnancy, and receiving prenatal and postpartum care at the study site. A follow-up phase involves surveys and qualitative assessments between 12 and 24 months postpartum to evaluate barriers and facilitators of cardiovascular health counseling and wellness interventions. Participants will undergo diabetes screening either immediately postpartum or during the standard postpartum visit, with data collected on screening rates up to 12 weeks after delivery. Patient-reported outcomes on cardiovascular health counseling will be gathered within 12 months postpartum, while patient perspectives on postpartum interventions will be assessed between 12 and 24 months postpartum. The study measures include diabetes screening rates, cardiovascular counseling experiences, lifestyle changes, primary care visits, and diabetes treatment satisfaction. This research helps identify ways to improve postpartum screening and cardiovascular health management for individuals with gestational diabetes.

Researchers are studying the human microbiome, which consists of bacteria and other microorganisms living on and inside the body, to understand how it affects health and disease. This observational study aims to build a repository of microbiome samples that can be used for future research. The study focuses on collecting biological specimens to improve testing methods and identify targets for new clinical trials related to microbiome-associated diseases. Participants of all ages, including healthy volunteers and those with various health conditions, are invited to provide samples such as stool, urine, saliva, vaginal fluid, breast milk, and cells from areas like the cheek, nose, mouth, skin, rectum, and vagina. Some samples can be collected at home using swabs, while blood samples may be drawn at a clinic or collected by finger or heel prick for young children. Intestinal and skin tissue samples may also be collected if participants undergo related medical procedures. During the study, participants will complete questionnaires about their medical history and diet. Researchers will collect and store various biological specimens to analyze the host microbiome response. These samples will help validate assays, optimize collection and processing techniques, and serve as controls for other studies. The study will continue until 2032, with ongoing monitoring of sample collection and analysis to support future microbiome research.

Researchers are evaluating the Enlighten Device to predict postpartum depression (PPD) by assessing its accuracy through true and false positive and negative rates based on outcomes collected up to 3 months after delivery. The study includes pregnant women aged 18 and older up to 33 weeks of gestation and aims to compare biomarker accuracy between blood and saliva samples and to assess the device's ability to identify women currently experiencing PPD at 6 weeks postpartum. Participants will be enrolled before 30 weeks of gestation and undergo blood collection during the third trimester at around 27 to 30 weeks, performed by mobile phlebotomists at home. The study will analyze biomarker results from the Enlighten Device using blood samples and compare these to saliva samples. Follow-up assessments occur at 2 weeks, 6 weeks, and 3 months postpartum to monitor depression symptoms and other health outcomes. Throughout the study, participants will complete interviews and various outcome measures at each postpartum visit. The main outcome is the percentage of participants with true or false positive and negative PPD results as determined by the Enlighten Device six months after delivery. The study also explores clinical factors influencing test accuracy and epigenetic markers to improve prediction. The total study period includes screening in the second or third trimester, third trimester sample collection, and postpartum follow-up visits.