Pregnancy

This is a single-center, prospective, single-blind randomized controlled trial. The investigators plan to recruit 144 pregnant women scheduled for cesarean delivery. Participants will be randomly assigned to receive either combined spinal-epidural anesthesia (CSEA) or general anesthesia (GA). The study aims to compare the effects of these two anesthetic techniques on neonatal hearing after cesarean delivery. The investigators will collect neonatal transient evoked otoacoustic emission (TEOAE) screening results and conduct follow-up hearing assessments at 3-6 months of age for infants who fail repeat screening. The investigators will also record maternal intraoperative hemodynamic changes, the interval from anesthesia initiation to neonatal delivery, neonatal Apgar scores at 1 and 5 minutes, and maternal postoperative pain scores at multiple time points.

Many pregnant people don't get the dental care they need, even though it's safe and important. The CHEER Study offers free dental check-ups, cleanings, and supplies to help participants take care of their teeth and gums during pregnancy. The purpose of this research study is to compare two types of noninvasive oral health interventions to evaluate their effectiveness. We want to learn if one method is more effective in supporting oral health and improving pregnancy outcomes. There are two aims of this study: Aim 1: To evaluate whether a structured oral health intervention reduces periodontal inflammation during pregnancy and postpartum in pregnant people with indicators of periodontal disease. Aim 2: To assess whether a structured oral health intervention is associated with changes in oral health behaviors or birth outcomes in pregnant people with periodontal disease.

To achieve global elimination of hepatitis B virus (HBV), it is crucial to eliminate HBV mother-to-child transmission (MTCT) by ensuring high coverage of birth dose vaccine and expanding the adoption of peripartum antiviral prophylaxis (PAP) by tenofovir. Current international guidelines require hepatitis B surface antigen (HBsAg)-positive pregnant women to undergo viral load (VL) quantification to identify those at high risk (VL ≥200,000 IU/mL) who should receive PAP. However, VL testing remains inaccessible in many low- and middle-income countries (LMICs), particularly in rural areas. Consequently, in the forthcoming guidelines, the WHO is going to issue a conditional recommendation for administering PAP to all HBsAg-positive women lacking access to VL testing. Although this universal strategy may appear promising for simplifying the diagnostic process, it may result in overtreating the majority of HBsAg-positive pregnant women, estimated at 85% in Africa and 70% in Asia, for whom birth dose vaccine is likely sufficient. Moreover, the real-world applicability of this strategy in LMICs has never been formally tested. As an innovative alternative, the adoption of a rapid point-of-care test for hepatitis B core-related antigen (HBcrAg-RDT) is proposed to identify women eligible for PAP.This test requires only a drop of capillary blood, eliminating the need for electricity or centrifugation, and can provide a reliable result within 45 minutes. Compared to the universal strategy, HBcrAg-RDT strategy is expected to be less expensive and could prevent unnecessary tenofovir exposure for both women and their fetuses. Our aim is to establish the non-inferiority of the HBcrAg-RDT strategy, in comparison to the universal strategy, in terms of effectiveness, defined as the reduction in maternal VL at the time of childbirth, a main driver of the MTCT risk. This will be approached through a multidisciplinary framework integrating health economics, implementation science, and health policy analysis.

Purpose: The primary objective of this study is to assess the diagnostic accuracy of an AI-enabled ultrasound tool for estimating fetal weight Participants: 1,000 pregnant individuals Procedures (methods): This prospective diagnostic accuracy study will enroll 1,000 pregnant individuals within one week of anticipated delivery. At a single visit, each participant will undergo two ultrasound assessments: (1) standardized sweeps for AI analysis (performed by both specialist and nonspecialist users), (2) specialist-performed fetal biometry.

Food insecurity affects up to 30% of pregnancies and leads to worse health in pregnant people and their children, including an increased risk of gestational diabetes, pre-term birth, and future cardiometabolic chronic conditions (e.g., type 2 diabetes and obesity). Interventions are being utilized to address food insecurity in clinical care settings, but patients differ in the support needed to reduce food insecurity and health systems have limited resources to invest in these interventions. Rather than a single intervention, adaptively allocating interventions could be a more effective, equitable, and efficient approach to improve food security; the objectives of this pilot study are to determine the feasibility of recruiting, retaining, and adaptively providing food insecurity interventions to pregnant patients in anticipation of a large, definitive trial in the future.

The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.

This is a prospective, single-centre, quasi-experimental before-and-after study. Women due to give birth at the participating centre will be informed about the study during their 9th-month antenatal appointment. Only expectant mothers for whom cervical ripening is indicated will be included. During the BEFORE period, cervical ripening will be offered to them according to the method chosen by the healthcare team following a discussion of their case at a team meeting. During the AFTER period, the various possible methods of cervical ripening will be offered to the patient, and the choice of method will be left to her. The participants' experiences will be compared using the QEVA self-assessment questionnaire, completed two days after delivery.

Preeclampsia is a leading cause of maternal and neonatal morbidity and mortality. There is a lack of effective therapeutics for prevention or treatment. Our previous ex vivo work demonstrated that mitochondrial-antioxidants can reverse placental microvascular damage. Therefore, this study will evaluate whether MitoQ (Mitoquinol Mesylate, a mitochondrial-antioxidant) has the potential to restore vasodilation, improve placental function, and therefore promote pregnancy prolongation in patients with gestational hypertension (gHTN) and/or preeclampsia. This evaluation of clinical data, patient samples, and vascular function studies in patients with gHTN and/or preeclampsia could translate into a viable therapeutic option.

Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics

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 goal of this clinical trial is to learn whether transcranial magnetic stimulation, also called TMS, is a practical and acceptable treatment option for methamphetamine use disorder during pregnancy. The study will enroll pregnant women who have methamphetamine use disorder. The main questions it aims to answer are: 1. Can pregnant women with methamphetamine use disorder be successfully enrolled and complete TMS treatment? 2. Is TMS acceptable to pregnant participants, their caregivers or partners, and clinicians involved in their care? 3. Is it feasible to collect maternal and infant health information during pregnancy and after delivery? Researchers will compare standard 4-week TMS, accelerated 2-week TMS, and treatment as usual to see which approach is more practical and better tolerated during pregnancy. Participants will: * Be randomly assigned to receive standard TMS, accelerated TMS, or treatment as usual. * Complete study visits during pregnancy and follow-up visits after treatment. * Complete questionnaires about substance use, cravings, mood, anxiety, sleep, quality of life, and side effects. * Provide urine drug tests and have vital signs and safety assessments completed. * Allow the study team to review pregnancy and infant medical records. * Some participants will complete interviews about their experiences and views of TMS during pregnancy.

This study is a randomized controlled trial comparing two models of doula support for pregnant individuals enrolled in Medicaid: an enhanced doula support model, in which support starts earlier in pregnancy, occurs more frequently, and continues through the first year after birth, versus the standard doula care currently covered by Medicaid in Florida. The study also builds the doula workforce needed to sustain this model of care, training doulas to become eligible to bill Medicaid for their services. The primary goal is to determine whether the enhanced doula model results in significantly lower rates of perinatal depressive and anxiety symptoms compared to standard doula support, while gathering data on real-world implementation. The study also evaluates the effectiveness of Medicaid-covered doula services more broadly, with findings intended to inform state-level policy on Medicaid reimbursement and the extension of doula services into the postpartum period.

This study focuses on elucidating the changes of hemodynamics assessed by USCOM and respiratory mechanics assessed by impedance oscillometry (IOS) over the course of pregnancy and the postpartum period. Additionally, to understand how these changes over the course of gestation relate to the development of preeclampsia.

An increasing proportion of patients undergo labor induction at the end of pregnancy. Balloon induction at home is a method validated in the literature. Home-based balloon induction is already part of routine care at the Paule de Viguier maternity unit. However, a prospective evaluation of this home induction option has not yet been conducted at our facility or elsewhere in France. Our study will evaluate obstetric outcomes and patient satisfaction regarding this induction method at our center. This is an observational, non-interventional, prospective, and comparative-though non-randomized-study.

This clinical trial is about prenatal genetic screening. It will test an intervention to help people make decisions about screening. The intervention is a short set of information cards about screening. This intervention is for pregnant participants. They will use the intervention on their mobile phone before they see their doctor. The study has one main question: * Do participants who use the intervention feel more confident when they make a decision about screening? Researchers will compare participants who use the intervention to participants who do not. All participants will have their usual care when they visit their doctor. What will participants do? * Participants must be pregnant. They will sign up for the study before their first doctor's visit for their pregnancy. This is the visit where their doctor usually talks with them about screening. * Some participants will use the intervention before their first doctor's visit. Other participants will not use it. * All participants will talk with a researcher on the phone after their first doctor's visit. * Participants who use the intervention will answer a short survey on their phone. * A few participants who use the intervention will talk with a researcher a second time on the phone.

This is a study to evaluate pregnancy in patients with myeloproliferative neoplasms. The main endpoint of this study is to determine the number of live births in pregnant MPN patients who are managed by a risk-adapted algorithm

This study is a randomized controlled trial evaluating the impact of a video-informed training session on maternal and newborn health care seeking in rural Côte d'Ivoire.

The goal of this clinical trial is to learn whether cabergoline can prevent lactation and reduce breast symptoms in pregnant people aged 18 years or older undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation. The main questions it aims to answer are: Does cabergoline decrease the proportion of participants who experience breast symptoms (including breast engorgement, milk leakage, tenderness, and need for pain relief) after abortion or pregnancy loss? Does cabergoline reduce the severity of breast symptoms and associated bother compared with placebo? Researchers will compare participants receiving cabergoline to those receiving placebo to determine whether cabergoline reduces the frequency and severity of breast symptoms following abortion or pregnancy loss. Participants will: Complete a baseline survey assessing breast symptoms prior to the abortion or pregnancy loss procedure Receive a single oral dose of either cabergoline (1 mg) or placebo approximately one hour after the procedure Complete follow-up surveys on days 2, 3, 4, 7, and 14 after the procedure to assess breast symptoms and related bother A subset of participants will provide blood samples at selected time points to measure serum prolactin levels

The goal of this clinical trial is to learn if a nutritional intervention based on a Mediterranean diet (MedDiet), initiated early in pregnancy, reduces the incidence of gestational diabetes mellitus (GDM) and other adverse maternal, fetal and obstetric events in pregnant women considered high-risk. It will also learn about the stratification of GDM risk based on clinical, anthropometric, analytical and genetic characteristics. The main questions it aims to answer are: * Does the nutritional intervention based on MedDiet reduce the incidence of GDM in women with high risk? * How can we stratify the risk of GDM? Researchers will compare an advanced nutritional intervention based on a Mediterranean diet to standard care (general recommendations given at the beginning of pregnancy). Participants will: * Receive intensive nutritional counselling or standard regular recommendations during the first trimester of pregnancy. * Visit the clinic at the time of the first ultrasound (gestational week 8-11) and at the time of screening for GDM (gestational week 24-26). * Undergo a genetic test performed with a buccal swab.

The goal of this clinical trial is to evaluate the potential benefit to patients and providers from using the remote fetal-monitoring system NUVO along with its app to allow for pregnant patients requiring weekly non-stress testing to do so from their homes. The main questions the investigators are looking to answer are: What effect does the NUVO remote fetal monitoring system have on patient/provider satisfaction? What is the cost savings (both direct and indirect) from using a remote fetal monitoring system as opposed to in-person testing for both the patient and the provider? Researchers will compare the survey responses by both patients and providers for pre and post implementation of the NUVO fetal monitoring system to the survey responses of patients and providers who used the traditional in-clinic method to evaluate satisfaction and cost savings. Participants will: Answer pre-implementation surveys before undergoing the trial Be randomly assigned to do either fetal testing at-home or in-clinic once or twice weekly as up to the provider Before hospital discharge or within the last office visit participants will be given a post-implementation survey

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.

The goal of this clinical trial is to examine how daily behavioral patterns in early pregnancy, including sleep, physical activity, and meal timing, influence continuous glucose dynamics and subsequent risk of gestational diabetes mellitus (GDM) in pregnant women without pre-existing diabetes. The main questions it aims to answer are: 1. Do early-pregnancy chronobehavioral patterns (e.g., irregular sleep, night eating, and unstable rest-activity rhythms) relate to continuous glucose patterns measured using continuous glucose monitoring (CGM)? 2. Can early behavioral and CGM-derived measures predict glucose regulation and metabolic outcomes later in pregnancy (24-28 weeks)? 3. Does real-time self-monitoring using wearable devices and food logging improve glycemic outcomes compared to usual care? This study is a prospective, nested randomized pilot trial embedded within the ongoing Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) cohort (NCT06293235) at KK Women's and Children's Hospital, Singapore. A total of 140 pregnant women without pre-existing diabetes, recruited at ≤13 weeks gestation, will be randomized in a 1:1 ratio to either a pilot arm (wearable-based self-monitoring) or a control arm (usual care). Participants in the pilot arm (n=70) will undergo intensive behavioral and metabolic monitoring over a 14-day period in early pregnancy, including continuous glucose monitoring using a CGM device, wrist actigraphy to assess sleep-wake and rest-activity patterns, and an AI-supported mobile application to record meal timing and dietary intake. Participants will have real-time access to their glucose data and behavioral feedback, enabling self-monitoring and potential behavioral adjustments.

This randomized controlled trial aims to evaluate the effect of podcast-supported prenatal education based on the Health Promotion Model on empowerment, healthy lifestyle behaviors, and quality of life among pregnant women. A total of 60 pregnant women at 8-12 weeks of gestation who meet the eligibility criteria will be included in the study and randomly assigned to an intervention group (n=30) or a control group (n=30) using block randomization. At baseline, participants in both groups will complete a Descriptive Information Form, the Healthy Lifestyle Behaviors Scale in Pregnancy, the Pregnant Women Empowerment Scale, and the Pregnancy Quality of Life Scale. Following the baseline assessment, participants will be informed about the study process and the intervention schedule. Participants in the intervention group will receive a four-week online prenatal education program based on the Health Promotion Model, consisting of eight educational modules delivered twice a week. After each educational session, a podcast related to the session content will be shared with the participants. During the intervention period, participants will also receive reminders to listen to the podcasts and motivational messages to support their participation in the program. Participants in the control group will receive routine prenatal care and will be included in a WhatsApp group for communication related to the study. They will not receive the podcast-supported prenatal education program during the intervention period. The Healthy Lifestyle Behaviors Scale in Pregnancy, Pregnant Women Empowerment Scale, and Pregnancy Quality of Life Scale will be administered to participants at three time points: baseline at 8-12 weeks of gestation, immediately after completion of the educational intervention at 20 weeks of gestation, and at 32 weeks of gestation. Changes in empowerment, healthy lifestyle behaviors, and quality of life will be compared between the intervention and control groups.

The goal of this feasibility randomized controlled trial is to assess the feasibility, acceptability, and demand, as well as preliminary effects of an evidence-based Intuitive Eating (IE) intervention among pregnant women who have obesity. The main research questions are: RQ1: What is the feasibility (acceptability and demand) of implementing an Intuitive Eating Intervention among pregnant and postpartum women? RQ2: How does participation in the Pregnancy Intuitive Eating Intervention (PIE-I) impact key maternal health outcomes (i.e., gestational weight gain, intuitive eating behaviors, dietary quality, body image, and mental health) compared to a wait-list control? Researchers will compare the Pregnancy Intuitive Eating Intervention (PIE-I) intervention group with the wait-list control to see what impact the PIE-I has on maternal well-being. Participants randomized to the intervention group will complete the 8 week asynchronous IE intervention and have an opportunity to interview at the end of the study.

Background: The microbiome is the bacteria and other microorganisms that live inside and on the body. The microbiome is important for our health. Researchers study how the microbiome help people stay healthy. They study how the microbiome affects the body when people get sick. To do this research, they need samples of the microbiome living on the bodies of many people. The purpose of this natural history study is to collect microbiome samples in a repository. These samples will be used for future research. Objective: To collect microbiome samples from the body that can be used for future research. Eligibility: People of any age. Only those older than 3 years will be seen at the NIH clinic. Design: Participants will fill out a questionnaire. Topics will include their medical history and foods they eat. Participants will be asked to give 1 or more of the following: Stool, urine, saliva, vaginal fluid, and breastmilk. These samples can be collected at home and sent to the researchers. Cells from participants cheek, nose, mouth, skin, rectum, and/or vagina. The cells may be collected by rubbing the area with a sterile cotton swab. These procedures can also be done at home. Blood. Blood may be drawn using a needle inserted into a vein in the arm. For young children, blood may be collected by a prick on the heel or finger. Intestinal tissue samples. These may be collected from participants who are having an endoscopy or colonoscopy for other reasons. Skin tissue samples. These may be collected from participants who are having biopsies for other reasons.