Labor and Delivery Complication

Spinal anesthesia-induced hypotension is a common and significant complication affecting up to 50-80% of pregnant women undergoing elective cesarean section. This trial evaluates whether a brief 5-minute mindfulness-based breathing exercise given just before spinal anesthesia can influence blood pressure changes during surgery. The study compares this breathing technique to standard care in pregnant women aged 18 to 45 years scheduled for elective cesarean delivery. Participants will be randomly assigned to either perform the mindfulness-based breathing exercise or receive standard preoperative care. The breathing exercise involves slow diaphragmatic breathing at about six breaths per minute, guided by a trained anesthesiologist or nurse, with mindful repetition of the phrase "My body is relaxing as I exhale." Both groups receive spinal anesthesia with specific medications, and careful monitoring of heart rate and blood pressure is performed. During the study, participants will be closely observed for changes in systolic blood pressure and heart rate within 10 minutes after spinal anesthesia. Anxiety levels, incidence of early hypotension, and medication use to support blood pressure will also be measured. The trial includes standard monitoring such as ECG and oxygen saturation, with safety and response data collected throughout the procedure. Participants' involvement includes a short breathing exercise or equivalent wait time before anesthesia, with follow-up assessments during surgery.

Placenta accreta spectrum disorders (PASD) include abnormal implantation of the placenta into the uterine wall, such as placenta accreta, increta, and percreta. This condition is a significant obstetric concern, and current antenatal diagnostic methods do not provide complete certainty in diagnosis. This study aims to compare two common ultrasound methods, 3D ultrasound and 2D ultrasound with color Doppler, to assess their effectiveness in diagnosing placenta accreta spectrum. The study evaluates 3D ultrasound using placental volume measurements and vascular indices including vascularization index, flow index, and vascularization flow index. The 2D ultrasound assessment includes examining placental invasion criteria such as lacunar vascular flow, abnormal utero-placental interface, myometrial thinning, absence of retroplacental myometrium, interruptions at the utero-vesical interface, and lower uterine segment hypervascularity. These two diagnostic approaches are observed and compared during the study period. Participants will be pregnant women diagnosed with placenta previa and will undergo ultrasound examinations using both 3D and 2D methods. The primary outcome measure is the vascular index assessed at 1 month. Secondary outcomes include evaluation of 2D ultrasound parameters at the same time point. This observational study involves ultrasound imaging to monitor placental characteristics and blood flow, aiming to improve antenatal diagnosis of placenta accreta spectrum disorders.

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 postpartum hemorrhage (PPH), a serious complication during and after childbirth that can cause significant health problems for mothers. This trial aims to improve how the risk of PPH is predicted using a new computer model that considers 21 factors and updates automatically during labor. The study compares this new model combined with a provider-facing alert system to current basic risk tools, with the hope of improving outcomes for mothers. The study includes two groups: one receives the usual care with a traditional category-based risk assessment, and the other group receives standard care plus the new risk prediction model. If the new model predicts a risk of 3% or higher, it triggers an alert recommending best practice steps like preventive medications. Providers can decide whether to follow these recommendations. Both groups receive standard care risk assessments as part of their admission process. Participants are all women admitted for vaginal or cesarean delivery at the medical center. Researchers will collect and compare data on a range of health outcomes related to bleeding and complications from the time of delivery until 30 days later. They will use hospital records to measure blood loss, treatments given, length of stay, and other health events. The study aims to see if the new model and alerts lead to better health outcomes for mothers during and after childbirth.

Researchers are studying how serum kisspeptin levels change throughout pregnancy in women with polycystic ovary syndrome (PCOS). This study aims to understand the relationship between kisspeptin, insulin, glucose, and testosterone levels, and to explore whether kisspeptin can predict gestational diabetes mellitus (GDM) and other pregnancy complications in PCOS patients. The study is observational and focuses on pregnancies affected by PCOS using the 2003 Rotterdam diagnostic criteria. The study includes two groups: pregnant women aged 18 to 40 diagnosed with PCOS before pregnancy, and healthy pregnant women in the same age range without PCOS. Participants will be registered for prenatal check-ups during the first trimester. This is an observational study, so no specific treatments or interventions will be given. Researchers will monitor kisspeptin and related hormone levels at different stages of pregnancy. Participants will be followed throughout pregnancy, with assessments to measure dynamic changes in serum kisspeptin over 40 weeks. The study will also evaluate how kisspeptin levels relate to the development of GDM and insulin resistance. Participants will undergo regular check-ups, laboratory tests, and hormone measurements. The study will help understand hormonal changes in PCOS pregnancies and their potential impact on complications, with a total participation time covering the full pregnancy period.

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.

The purpose of this study is to determine whether participation in the Play and Learning Strategies (PALS) parenting intervention results in increased caregiver responsiveness behaviors and to test if participation in PALS results in increases in toddler skills and/or toddler neurological development.

Researchers are evaluating the impact of wearable, wireless breast pumps on how often and how much milk mothers of premature infants can express. This randomized controlled crossover trial focuses on mothers whose infants were born at or before 29 weeks and 6 days of gestation. The study aims to compare milk expression frequency and volume using wearable pumps versus standard hospital-grade pumps to improve milk accessibility for NICU mothers. Participants will use a wearable, wireless breast pump in addition to their usual hospital pump. The study follows a crossover design where mothers receive the wearable pump with lactation specialist support either during the first or second week, with the other week using standard care. This allows comparison between the two methods over two consecutive weeks. Mothers will be monitored for the number of pumping sessions and volume of milk expressed over seven days in each study period. Researchers will collect data on milk volume, percentage of required volume pumped, and pumping frequency. The study involves support from lactation specialists and aims to assess how the wearable pump affects milk expression in real-life settings such as cuddling the baby or performing daily activities.

Researchers are studying the best timing for labor induction in low-risk pregnant women in China. This trial compares induction at 39 weeks, induction at 41 weeks, and expectant management to see which approach leads to fewer cesarean deliveries and better outcomes for mothers and babies. The study will also use advanced techniques to analyze cord blood for early markers linked to child health. It starts with a pilot phase to test feasibility and plan for a larger study. Participants will be randomly assigned to one of two groups: induction of labor between 39 weeks 0 days and 39 weeks 4 days, or expectant management until spontaneous labor or induction at 41 weeks. The trial focuses on women assessed as low-risk for delivery before 41 weeks. The study aims to generate evidence specific to the Chinese population to support safer and more personalized care. During the study, women will be monitored for delivery outcomes, including cesarean rates and maternal and newborn health indicators. Researchers will collect data on various maternal and neonatal complications, hospital stays, and costs. Follow-up assessments will occur at hospital discharge and at 6 weeks and 6 months after birth, including developmental evaluations of the child. The main outcome measured is the rate of cesarean delivery on the day of birth.

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.