Ectopic Pregnancy

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.

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.

This research aims to reduce Black-White maternal health disparities by using interventions to decrease bias in prenatal care, improve care coordination, and increase social support. Known as ACURE4Moms, this pragmatic 4-arm cluster randomized controlled trial involves 39 prenatal practices across North Carolina. The study focuses especially on reducing pregnancy complications and low birthweight deliveries among Black patients, who face higher risks related to institutional racism and discrimination. The study compares four groups: standard care with Medicaid care management for high-risk pregnancies; care management plus Data Accountability and Transparency interventions including electronic warning systems, disparities dashboards, and racial equity training; care management plus Community-Based Doula support providing culturally relevant care during pregnancy, labor, and postpartum; and a combination of both Data Accountability and Transparency and Doula Support interventions. Each practice participates for two years, initiating prenatal care for approximately 750 to 1,500 patients, with outcomes tracked through delivery and one year after birth. Participants include patients who self-identify as Black or African American receiving prenatal care at participating clinics. Researchers collect data from electronic health records on low birthweight and other pregnancy outcomes and gather patient experiences of discrimination through internet surveys at four time points from the first prenatal visit to three months postpartum. Additional interviews with staff, doulas, and facilitators help assess intervention fit. The study is led by a Stakeholder Advisory Board focusing on patient-centered outcomes and policy advocacy.

This research aims to develop a multi-level intervention called TENDAI4PrEP, adapted from the TENDAI program, to improve uptake and persistence of oral pre-exposure prophylaxis (PrEP) among pregnant persons in Zimbabwe. The study addresses the urgent public health need due to Zimbabwe's high HIV prevalence, especially among cisgender women of reproductive age, and aims to overcome barriers such as psychological distress, stigma, low partner support, and limited provider knowledge. The intervention involves 4-5 problem-solving sessions including one with a partner and an optional postpartum booster, incorporating PrEP education, psychoeducation, and a culturally adapted Life Steps approach. Participants are randomized to either the TENDAI4PrEP intervention or enhanced treatment as usual (ETAU), which includes monthly antenatal care visits and educational pamphlets. Providers at the clinics also receive training to improve PrEP knowledge and reduce stigma. Participants will be involved in assessments over approximately five months post-baseline, including evaluations of feasibility and acceptability of the intervention and provider training. Measurements include self-reported PrEP adherence, psychological distress, PrEP persistence, and changes in provider knowledge and stigma. Qualitative interviews with providers and administrators will explore implementation outcomes to prepare for larger-scale testing.

This research aims to evaluate a new advanced wireless skin sensor system designed to monitor vital signs in healthy newborn infants of at least 35 weeks gestational age. The study focuses on assessing the feasibility, safety, and accuracy of this wireless system compared to the standard wired monitoring during the first two hours after birth, especially during unsupervised parental care in the obstetrical center. The goal is to improve early detection and prevention of Sudden Unexpected Postnatal Collapse (SUPC), a rare but serious condition affecting newborns shortly after delivery. Participants will have both the wireless monitoring system and the standard wired system placed on their chest and limb. For vaginal births, the wireless system is placed first, followed by the wired system after 15-20 minutes; for C-section births, the order of placement is randomized. Both monitoring systems remain in place for two hours to continuously record vital signs such as heart rate, respiratory rate, oxygen saturation, and skin temperature. During the study, newborns' vital signs will be recorded and compared between the two systems for up to two hours immediately after delivery. Researchers will evaluate the feasibility by checking for gaps in data and user satisfaction, assess safety through skin and pain scores, and measure accuracy using statistical comparisons. The study also includes monitoring the time between sensor placement and data display. Participation lasts only the initial two-hour period after birth, with monitoring done under real-world conditions in the obstetrical center.

Researchers are evaluating the use of the Femom device, a non-invasive fetal ECG tool designed for self-application and remote monitoring, to track fetal heart rate in both low and high-risk pregnancies. The study aims to determine if remote recordings from Femom provide reliable information about the baby's heart rate and to establish reference standards for heart rate variability during uncomplicated pregnancies at various stages. It will also compare heart rate variability in pregnancies affected by fetal growth restriction (FGR) and insulin-dependent diabetes to normal pregnancies. Participants are divided into three groups: low-risk controls, FGR pregnancies, and insulin-dependent diabetic pregnancies. Women in the control group will monitor their baby's heart rate once a day for one week. Those in the FGR group will monitor daily until delivery, while women with insulin-dependent diabetes will monitor daily from 36 weeks until delivery. Data collected will be analyzed to assess participant adherence, signal quality, and heart rate variability, along with usability feedback from questionnaires. During the study, participants will monitor their baby's heart rate at home using the Femom device. Researchers will collect and analyze fetal heart rate (FHR) and maternal heart rate (MHR) recordings over 60-minute periods. The study will also gather feedback on the device's ease of use and monitor pregnancy outcomes. Participants' involvement duration varies by group, with ongoing monitoring until delivery for high-risk groups. The study is observational and led by Biorithm Pte Ltd.

Researchers are evaluating infant outcomes in women with atopic dermatitis (AD) who used ruxolitinib cream during pregnancy compared to those who used topical corticosteroids (TCS). This observational retrospective cohort study uses data from US claims databases to assess safety and outcomes related to these treatments in pregnant women with AD. The study is sponsored by Incyte Corporation and focuses on pregnancy-related effects and infant health outcomes. The study observes two groups: infants born to women exposed to ruxolitinib cream during pregnancy and infants born to women exposed to topical corticosteroids before or during pregnancy. Women must have had at least one pharmacy claim for either ruxolitinib cream or a TCS, with continuous enrollment in the database from six months before conception through the end of pregnancy. Infant data are linked to maternal records and followed for up to one year after birth to assess outcomes. Participants will have their data reviewed for major congenital malformations up to 12 months after birth, small-for-gestational-age births at delivery, and overall pregnancy outcomes up to birth. The study excludes women who had pharmacy claims for oral ruxolitinib or other JAK inhibitors during the exposure window. Continuous enrollment in the database allows for detailed tracking of infant health and pregnancy outcomes over time.

This research aims to better understand how certain factors that control blood vessel growth, such as placenta growth factor (PlGF) and soluble FMS-like tyrosine kinase-1 (sFlt-1), are expressed by trophoblastic cells in healthy placentas from normal pregnancies at term. The study also seeks to explore how these factors relate to placental function and differentiation, which are important for a healthy pregnancy. The study involves observing placentas from scheduled cesarean deliveries after 37 weeks of pregnancy. Researchers will examine the gene and protein levels of these angiogenic factors in the placental tissue. Additionally, they may expose these healthy placentas to various chemical compounds to study their effects on placental biology and to explore potential therapeutic targets for pregnancy complications like pre-eclampsia and intrauterine growth restriction. Participants will be involved through collection of placental tissue during cesarean delivery. Researchers will measure levels of placental angiogenic factors on the day of collection and follow up on specific protein levels the next day. The study includes laboratory tests and tissue analysis to assess placental function and angiogenic factor expression, aiming to improve understanding of placental health and its disorders during pregnancy.

Researchers are evaluating the impact of Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) compared to conventional abdominal laparoscopy (CAL) for benign adnexal surgery in women aged 18 to 70. The study aims to confirm that vNOTES does not negatively affect women's sexual function after surgery, addressing concerns about vaginal scarring and its effects on sexual activity. Secondary goals include assessing vNOTES efficiency, complications, and the quality of histological analysis of surgical specimens. Participants will be randomly assigned to receive either the vNOTES or CAL surgical technique for procedures such as cystectomy, oophorectomy, salpingectomy, or tubal sterilization. Both approaches involve minimally invasive surgery, with vNOTES using the vaginal route and CAL using abdominal laparoscopy. The study also examines pain, hospital stay length, patient satisfaction, and surgical complications during and up to 30 days after surgery. Women in the study will complete questionnaires before surgery and at 3 and 6 months afterward to assess sexual function, couple satisfaction, and pain during sex. Medical and general data will be collected at enrollment, during hospitalization, and one month post-surgery. The main outcomes measured include quality of sexual life and postoperative recovery, while monitoring safety and the effectiveness of both surgical methods throughout the study period.

Pregnancy is a crucial time to assess and manage cardiovascular health risks for both mothers and their children. Researchers are studying the use of the American Heart Association's "Life's Essential 8" as a new way to evaluate cardiovascular health in pregnant women. The goal is to better understand how this tool can be applied and to develop appropriate cardiovascular health standards during pregnancy. The study involves observing pregnant women aged 20 to 49 who conceived naturally and are carrying a single baby. Participants will complete questionnaires, undergo clinical follow-ups, and provide specimens for analysis. The research focuses on monitoring cardiovascular health throughout pregnancy to explore its impact on pregnancy outcomes. During the study, researchers will track maternal and newborn health outcomes up to 42 weeks of gestation. Participants will be involved in routine prenatal checkups and data collection to support the study's assessments. This observational study helps gather important information on cardiovascular health during pregnancy without altering the standard care process.