Pregnancy Complications

A national multi-center open-label randomized controlled trial that investigates whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy improves maternal time in glycemic targets and fetal growth in women with type 1 diabetes compared to usual insulin treatment modality combined with Continuous Glucose Monitoring.

Objective assessment of the Changes in body composition of critically ill patients is very valuable. Ultrasound stands as a solution due to its portability, bedside availability, and radiation-free technology. Those criteria are crucial for critically ill obstetrics and gynecological cases.

The purpose of this research study is to see if using the MI MOM App improves pregnancy and postpartum health. There are two study groups, where one group is "treatment as usual" and the other is the "MI MOM App" group. Both groups will be asked to answer questions about their pregnancy health. Researchers will also retrieve vital records and Medicaid claims information related to pregnancy for both groups. Those in the "MI MOM App" group will receive mobile web app content and text messages with informational links and links to videos and micro-interventions. They will also identify up to three close friends or family members who will be invited to receive text messages. Those in the "MI MOM App" will also have the option to contact a community health worker as needed.

The purpose of this two-phase observational study is to investigate the use of ultrasonography to predict placental pathology at the time of delivery.

The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes. In this trial, 400 non-Hispanic Black participants will be randomized to see if 2 promising interventions (digital health interventions and community health workers) reduce adverse pregnancy outcomes.

The purpose of this randomized controlled trial is to establish the effectiveness of a culturally targeted and individually tailored behavioral intervention to promote maternal glucose metabolism in African American women.

ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional observational cohort study of nulliparous singleton pregnant women to evaluate biomarkers from blood and ocular imaging for prediction of pregnancy complications \[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\] and risk of adverse outcomes.

The goal of this clinical trial is to learn if a personalized prenatal support program \[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\[s\] it aims to answer are: * Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy? * Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy? * Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term? Researchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term. Participants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care. All participants will be asked to: * complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device. * complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit. People who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as: * a stress reduction toolkit; * access to an online website that can also be downloaded as a smart phone app; * the option to receive an electronic massage while in clinic, and more. * additional support gifts provided at routine clinical appointments People who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.

The overarching research question is: "Does the provision of healthy food (Delivering HOPE) during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with enhanced standard of care (ESoC)?" To answer this question, the investigators will conduct a large multi-site randomized controlled trial with 1,440 women. Women will be randomized to either the Delivering HOPE arm or the ESoC arm, with approximately 720 participants per arm. Participants randomized to the ESoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, WIC and SNAP enrollment assistance, referrals to safety net food organizations.Those randomized to the Delivering HOPE arm will be provided the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and food referrals, as well as a total of $1000/$2000/$3000 (depending on household size) during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records.

This study aims to evaluate the impact of a specifically designed exercise program for hospitalized high-risk pregnant individuals on bed rest. This is a specifically designed physical activiity program, consisting of a resistance and strength exercises intended to be performed even while in bed and seeks to address physical and emotional health challenges during hospitalization. The study will compare outcomes between participants who follow the exercise program and those receiving standard care. Primary outcomes include physical and emotional health parameters, quality of life, and sleep quality. Secondary outcomes focus on feasibility, adherence, and participant satisfaction. This research addresses the gap in physical activity guidelines for pregnant individuals on bed rest and explores the potential benefits of exercise to improve maternal well-being and postpartum recovery.

The current study is a single-blind, parallel-group randomized controlled trial involving 108 participants with diabetes during pregnancy. The trial will compare leg ergometer with arm ergometer. Interventions will be delivered three times per week for eight weeks. The primary outcomes are glucose, exercise tolerance, weight, and psychological stress. Assessments will be conducted at baseline and after eight weeks. The trial will be carried out at Jinnah hospital, Services hospital, Sir Ganga Ram Hospital, Lahore. The hypothesis is that the leg ergometer including aerobic exercise will result in greater reduction in glucose and exercise tolerance, weight and stress management than arm ergometer.

This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), and/or chronic Lyme (CL) either during or before a prior pregnancy. Participants will complete quantitative surveys on topics such as their medical history, their child(ren)'s development, and demographic information. They will then participate in a qualitative interview where they will be asked about their experiences with pregnancy and with parenting their child(ren) in the context of their condition.

The purpose of this pilot study is to assess the feasibility of longitudinal neurodevelopmental evaluation of fetuses and infants exposed to Lyme disease in utero. Participants with Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) will be recruited during pregnancy. Pregnancies will be monitored and infant development will be assessed from birth until age 18 months.

Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug use Participant Duration: Approximately 1 year. Aims: Aim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs. Aim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy.

The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

The surveillance of pregnancies at risk for fetal loss secondary to high-risk maternal or fetal conditions remains a mainstay of perinatal care. Current testing to prevent fetal loss includes the regular use of ultrasound (biophysical profile) or fetal heart rate monitoring (non-stress test) in an outpatient clinic setting once or twice weekly. A patient may also be asked to subjectively assess daily fetal movements during the time between routine antepartum testing appointments. However, there are no good systems for pregnant women to objectively measure fetal movements. Smartphones have allowed for the development of applications that utilize various embedded devices including the camera and microphone. In our recent pilot STUDY00001552 of 205 pregnant patients, placement of the iPhone10 microphone directly on the maternal abdominal wall was utilized to detect fetal movements. AI assessment of the audio recordings proved superior to maternal perception of fetal movements that were recorded during simultaneous ultrasound (gross fetal movements: 64% audio vs 18% maternal; breathing: 93% vs 3%, hiccups: 73% vs 3%). This trial is a prospective, observational, feasibility study of 60 patients that includes both low-risk and high-risk pregnant women to examine the usability of the Womb Watch smartphone application. The study will involve introduction of the Womb Watch app to a population of pregnant patients. Features of the app will be modified based on participant feedback. Anxiety levels of the patient will be tracked serially using a survey tool. The various types and versions of smartphones will be assessed to see if they affect the AI model. Finally, patients will be asked to determine the strength of fetal movements to see if this parameter can be assessed by the AI model. Amniotic fluid data will assessed through clinical ultrasounds to see if this also has any effect on the AI model's ability to detect fetal movements.

Preeclampsia is a leading cause of maternal morbidity and mortality. Low-dose aspirin prophylaxis reduces preeclampsia risk among high-risk pregnant individuals but remains underused in routine clinical practice. This pragmatic cluster-randomized implementation trial will test whether clinician notification of elevated preeclampsia risk increases aspirin prophylaxis utilization among eligible pregnant individuals receiving outpatient obstetric care. Clusters will be randomized to clinician notification versus usual care. In the intervention arm, obstetric clinicians will receive notification that a patient is at elevated risk for preeclampsia and a recommendation to consider initiation of aspirin prophylaxis between 12 and 28 weeks' gestation, as clinically appropriate. The intervention does not assign participants to aspirin and does not require any study-mandated medication. All decisions regarding aspirin prophylaxis will remain at the discretion of the treating obstetric clinician and patient.

The goal of this proof-of-concept, case-control, clinical trial is to evaluate the efficacy of using two newer ultrasound technologies, quantitative ultrasound (QUS) and ultrafast power Doppler imaging (uPDI), to evaluate the health of the placenta, visualize blood flow through the placental vasculature by color Doppler imaging in singleton pregnancies with and without fetal growth restriction (FGR). * Our primary objective is to investigate the ability of using these ultrasound technologies to distinguish healthy pregnancies from those affected by FGR, a condition characterized by a fetal weight below the 10th percentile for the gestational age or abdominal circumference of the pregnancy. * Secondary aims include longitudinal evaluation of differences in QUS and uPDI imaging over gestation and changes in these measures with evolution of utero-placental insufficiency including with the development of abnormal umbilical-artery Doppler testing, diagnosis of severe FGR, identification of stillbirth, and detection of preeclampsia or preterm birth. Investigators will compare QUS/uPDI imaging and values in pregnancies determined to be healthy by approved, standard-of-care growth ultrasounds to those diagnosed with FGR. Participants will receive research ultrasounds with the experimental Verasonics Vantage 256 system (Verasonics, Inc, Kirkland, WA) utilizing uPDI/QUS every three weeks following their routine growth ultrasound evaluation until delivery. Demographic, obstetric, and delivery-related information, as well as portions of subjects' past medical history will be utilized by researchers to further contextualize imaging and variables gathered during the research ultrasounds.

The researchers would like to know how long pregnant women spend in different positions during the night - and how often women change positions - across pregnancy. The researchers also want to see if the sleep monitor is able to improve sleep behaviors

The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a periviable delivery (deliveries occurring between 22 0/7 - 25 6/7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction.

Maternal AR has long been used to prevent PTB. However, definitions of AR vary widely, ranging from complete bed rest to partial limitation of physical activity for one or more hours daily. The use of maternal AR to prevent preterm birth is largely based on observational evidence linking strenuous physical activity to an increased risk of preterm birth, and the assumption that reduced activity may decrease myometrial activity. However, the existing evidence on the clinical effects of AR remains limited and has not demonstrated a reduction in preterm birth or a delay in deliv-ery. In contrast, some studies suggest a potential increase in preterm birth following AR and instead significant adverse maternal and fetal effects. The overall aim of this study is to compare gestational age at birth in women with a short cervix who are prescribed AR compared with women with a short cervix who are not prescribed AR (NAR). The primary hypothesis is that NAR is non-inferior to AR in prolonging pregnancy in women with a short cervix. Secondary hypotheses are that, compared with AR, NAR is associated with higher level of physical activity, lower risk of maternal depression, and reduced risk of loss of maternal bone mineral density. Through the BEWISE study, we wish to implement a change in the Danish national clinical practice regarding AR from recommending AR in risk groups (current practice) to no longer recommending AR as part as routine care (new practice). We will evaluate this change in clinical practice by prospectively collecting data from women both before and after implementation of the new recommendation. The transition from AR to NAR will be implemented sequentially in each Danish region using a randomised stepped-wedge (SW) cluster design, with each region constituting a cluster. The order in which regions transition is determined by randomisation. Each region will adopt the new recommendation at 3-month intervals, resulting in full national transition from AR to NAR within 12 months Eligible participants are pregnant women in gestational age 20+0 to 33+6 and cervical length \< 25 mm in singleton pregnancies and \< 30 mm in multiple pregnancies. Participants must be above 18 years of age and be able to read and understand Danish or English. There are no exclusion criteria. The primary outcome is gestational age in days (continuous).

Pregnancy increases the risk of thrombosis. Placenta-mediated diseases are a risk factor for cardiovascular pathologies and can lead to maternal-fetal morbidity and mortality. It is essential to understand the cellular and molecular mechanisms of dysfunctions at the vascular-placental interface so that systemic vascular risk can be characterized and, ultimately, screened for, on the basis of new markers (targeted preventive management). Deregulated autophagy could be the starting point for cell death by apoptosis or necrosis leading to complications. The pathophysiological mechanisms involved in trophoblast apoptosis are incompletely described. This project follows on from the GrossAuTop-1 study, which investigated the intra- and inter-individual variability of autophagy and apoptosis activities in women during pregnancy. The aim of this project is to study autophagy and apoptosis activities specifically in women developing a placental vascular complication during pregnancy.

This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.

Pregnant and postpartum patients hospitalized for medical complications experience high rates of depression, anxiety, and trauma-related symptoms, yet access to timely psychiatric care during obstetric hospitalization is limited. Project MOCHA integrates early mental health screening, trauma-informed psychotherapy, and structured follow-up into routine inpatient maternity care for individuals at elevated clinical risk. This single-arm implementation study examines the feasibility, acceptability, and fidelity of delivering a Collaborative Mental Health Care Program within a high-risk obstetric inpatient setting. The program includes brief inpatient psychotherapy, symptom monitoring, and post-discharge follow-up over three months. Preliminary changes in depression, anxiety, attention-deficit hyperactivity disorder, and posttraumatic stress symptoms will be assessed to inform future effectiveness trials and broader health system integration.

This pilot study aims to assess performance, safety and feasibility of U-CaVIT method (Uro-Catheter Vacuum Induced Tamponade), using the Rüsch® Brillant Silicone Balloon Catheter, an urological catheter, for the prevention of atonic PPH in high-risk women undergoing cesarean delivery. The U-CaVIT method has been implemented at the Department of Obstetrics at university hospital of Zurich (USZ) due to temporary supply issues with the Bakri® Balloon Catheter. The Rüsch® Balloon Catheter is used in case of uterine atony when standard first-line uterotonic treatments have failed or in some cases as add-on therapy in non-atonic PPH. In the meantime, the use of U-CaVIT has become standard practice at the USZ for the treatment of atonic PPH, appearing to be user-friendly, clinically effective according to treating physicians, well tolerated by the treated women and cost-saving compared to the previously used Bakri® Balloon.