Clinical Research Directory

Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder

The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are: * Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment. * To characterize prenatal opioid exposure (POE) related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging (MRI) and determine proteomic, genomic, and epigenetic signatures of NOWS and poor infant neurodevelopment. In this study participants will: * Receive two placental-fetal MRIs, one during second trimester and one in third trimester. * Answer surveys relating to their medical and social history. * Have blood drawn during pregnancy and delivery. * Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment.

Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.

Better Lifestyle Counseling for African American Women During Pregnancy

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.

Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight

This is a single-center, prospective observational study in patients undergoing cesarean delivery under spinal or combined spinal-epidural anesthesia. It compares whether continuous noninvasive hemodynamic measurements from the lower extremity (toe) better predict neonatal outcomes than upper extremity (arm/finger) measurements during spinal-induced hypotension. Participants receive standard spinal anesthesia and routine blood pressure management, with additional monitoring using the ClearSight™ system at both upper and lower extremities from before spinal anesthesia through delivery. The primary outcome is a composite of neonatal outcomes (APGAR scores, need for respiratory support, cord gases, and NICU admission). Secondary outcomes include maternal side effects and comfort. Overall, the study evaluates whether lower-extremity hemodynamic monitoring improves detection of clinically relevant hypotension and prediction of neonatal outcomes compared to traditional arm measurements.

LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

This study is being conducted to evaluate the safety and effect of starting daily use of low dose (100 mg) aspirin in pregnant women with sickle cell disease, who are being followed in two county hospitals in Angola, in the first trimester versus the second trimester of the gestational period.

Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain

The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.

Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation

The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first. This study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participants, the healthcare providers (HCP) involved in their care or the care of their infants, if applicable, and Albireo pharmacovigilance. Study start date is either start of data collection or first patient enrolled whatever occurs earlier. The surveillance program is strictly observational; the schedule of office visits and all treatment regimens are determined by HCPs. Only data that are routinely documented in patients' medical records as part of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this surveillance program.

Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy

The prevalence of type 2 diabetes mellitus (T2DM) in women of childbearing age is increasing rapidly, and low glucose compliance leads to an increased risk of adverse pregnancy outcomes for mothers and infants during pregnancy in women with T2DM. Real-time continuous glucose monitoring (CGM) is an important tool for glucose monitoring and patient education, as it can continuously record blood glucose throughout the day and provide real-time feedback on high and low blood glucose levels. This is a multicenter, open-label, randomized controlled clinical study to investigate the efficacy, safety, and maternal and infant pregnancy outcomes of using real-time CGM monitoring compared with conventional self-monitoring of blood glucose (SMBG) on the basis of multidisciplinary management in pregnant women with T2DM. One hundred and twenty pregnant women with T2DM in early pregnancy who were enrolled in intensive insulin therapy were randomly divided into the real-time CGM group and the conventional SMBG group. The real-time CGM intervention group wore real-time CGM for more than 50% of the pregnancy in addition to regular SMBG; the control group only performed regular SMBG. Both groups wore Medtronic iPro 2 for 3 days in early, mid and late pregnancy, and the time in the target range of blood glucose (TIR) was recorded in a blinded manner. Primary outcome: differences in TIR between the two groups of pregnant women in early, mid, and late pregnancy. Secondary outcomes included differences in glycated hemoglobin, hypoglycemia, insulin dose before delivery, pregnancy weight gain, and maternal and infant pregnancy outcomes.

Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy

The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period \[LMP\]). Information will be collected from participants, their healthcare providers, published studies, and safety databases. Reports of pregnancy linked to elafibranor from clinical trials, spontaneous reports, or literature will also be included, with steps taken to avoid duplicates. The study begins once the first participant is enrolled and ends after the last mother and child data are collected. It is planned to run for about 10 years, with infant follow-up lasting up to 2 years, for a maximum total duration of 12 years and 9 months. The program is strictly observational. All medical care, visit schedules, and treatment decisions remain with healthcare providers. Only routine medical record data will be collected, and no extra tests or procedures are required. Participation is voluntary, and written informed consent will be obtained before enrollment.

Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia

Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.

Trial of Community-based Patient Navigation

This study will test the effectiveness of a community-based patient navigator intervention from mid-pregnancy through 12 month postpartum for a high-risk population of medically underserved women. The RCT will enroll 540 pregnant women before 20 weeks of pregnancy and randomly allocate them into two different study arms from the time of prenatal enrollment through 12 months postpartum. If found to be effective, the community-based patient navigator intervention can be implemented as a standard of care at Grady and other provider practices serving high-risk women to improve maternal health outcomes and reduce racial disparities.

Impact of Lactation Antenatal Teaching by Clinicians and Healthcare Providers

The purpose of this study is to increase the rate of exclusive breastfeeding at 6 weeks postpartum in the Inland Empire by addressing inadequate antenatal breastfeeding education for patients.

The Laughter, Pregnancy, Anxiety and Llife Quality

Gestational Diabetes is one of the most common medical complications during pregnancy. It is seen between the 24th and 28th weeks of pregnancy with the increase in insulin resistance in the second trimester and ends with the end of the birth process. Due to this feature, it is distinguished from Type 2 diabetes. This disease, which is seen for the necessary energy needs of the fetus and placenta, is defined as the diabetogenic effect of pregnancy. Laughter is a universal response to humorous stimuli that exists in our lives. Laughter yoga is holistic with breathing techniques. It is a form of yoga that utilizes the brain's inability to distinguish between real and fake laughter. Laughter yoga helps people cope with stressful times and helps the person control themselves by reducing negative cognitive reactions. In line with this information, the aim of the study was to determine the effect of laughter yoga applied to pregnant women with gestational diabetes on perceived stress and quality of life.

The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections

During caesarean section, blood pressure variations especially a reduction in blood pressure (or hypotension) can bring harmful effects to mother and baby. This usually occurs after spinal anaesthesia is administered. Usually, the anaesthetist will treat hypotension as it occurs. However, a new medical device is now available to predict hypotension. It is called the Hypotension Prediction Index (HPI). This device allows the prediction of hypotension; hence, treatment can be given before it occurs. It has been widely utilised in major surgeries like abdominal tumour surgery and cardiac surgery worldwide and has shown a substantial reduction in hypotension. This study aims to determine whether the duration and severity of hypotension can be reduced when HPI is used in lower segment caesarean sections. The secondary objective of the study is to determine if the complication rate can be reduced in both mother and baby.

Effects of Systematic Cervical Exam Training on Labor and Delivery Care

All physicians, nurses, and nurse midwives working on Labor and Delivery will be required to complete cervical exam simulation training. Data before and after institution of the training will be compared to determine if the training leads to less cervical exams during labor and increases consistency between examiners

Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa

Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV. However, posttraumatic stress (associated with intimate partner violence and/or other traumas) and depression negatively impact PrEP adherence among women in SA. Addressing posttraumatic stress and depression will likely improve PrEP adherence and persistence (i.e., sustained PrEP adherence over time) during pregnancy and breastfeeding, which are periods of dramatically increased HIV risk. The overarching goal of this proposal is to develop and test the feasibility and acceptability of a cognitive behavioral intervention that targets common underlying factors of posttraumatic stress and depression to improve PrEP adherence and persistence during pregnancy and the postpartum transition. The specific aims of the project are to (1) explore the mechanisms by which posttraumatic stress and depression impact PrEP adherence and persistence during pregnancy via qualitative interviews; (2) develop a brief PrEP adherence and persistence intervention (\~4 sessions) that reduces the negative impact of psychological mechanisms common to posttraumatic stress and depression on PrEP use, and builds behavioral skills to improve self-care; and (3) evaluate the feasibility, acceptability, and signals of preliminary efficacy of the intervention, which will be integrated into antenatal care, in a pilot randomized controlled trial. All data will be collected in the Midwife Obstetrics Unit (MOU) in Gugulethu, a peri-urban settlement and former township community outside of Cape Town, SA.

WAKIX® (Pitolisant) Pregnancy Registry

The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.

Fetal MRI Acquisition and Sequence Development

Testing of new magnetic resonance imaging (MRI) pulse sequences (image acquisition software) for imaging the fetus to improve workflow and image quality in fetal imaging and diagnosis. The investigators would like to develop novel MRI approaches to enhance fetal imaging with MRI, in the presence of motion. As part of technical development, the investigators plan to develop methods to improve structural T1 and T2 weighted images, MR angiography, diffusion and spectroscopy measurements of the fetus.

Community-based Implementation of Adapted STAC

This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).

STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy

This research will test the effectiveness of a prenatal provider education and training program designed to facilitate provider adoption of evidence-based practices for the treatment of OUD during pregnancy. Findings from this research will provide high quality evidence about how to increase evidence-based treatment for pregnant women with OUD and subsequent maternal-child health outcomes.

Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial

This is an open-label individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.

Care4mommies in Action: A Compassion-based Intervention

Becoming a mother is a life-changing event that many experience as a time of joy and affection. However, it can also be a period of great vulnerability and uncertainty with the potential to hinder the mother's well-being and bonding with the baby, and undermine the child's later emotional, social, and cognitive development. The mothers' emotional regulation skills, namely self-compassion, may be useful in protecting the mother and the mother-baby bonding, making them a valuable target of intervention during the perinatal period and a potential protective factor for mental health. Although compassion-based interventions (CBIs) have been proven effective in promoting well-being and reducing mental health difficulties across diverse populations, including the perinatal period, evidence of their impact on maternal well-being and the mother-baby bond remains limited. Thus, the research team propose to explore the acceptability, feasibility, and preliminary efficacy of a CBI during pregnancy on mothers' compassion abilities, and consequent impact on well-being and quality of mother-baby bonding at postpartum. This pilot cluster randomised trial addresses the research question of 'Does the Care4mommies intervention work to promote mothers' compassion and higher quality of the mother-baby bonding?' Participants will be mothers enrolled in group birth preparation courses (i.e., TAU); those groups will be randomly allocated to Care4mommies plus TAU or TAU only and assessed at pre-intervention and post-intervention(prepartum), and 3-month follow-up(postpartum). At pre- and postintervention, participants will be asked to provide self-reported information on self-compassion, shame and guilt about caring, maternal-fetal attachment, fear of self-compassion, self-criticism, and mental health. At post-intervention, they will also be asked to appraise data collection procedures and the implementation feasibility of the Care4mommies; at follow-up, they will be asked to report on their bonding to their baby. Researchers expect that participants in the Care4mommies plus TAU condition will report significant gains at post-intervention and sustain them until follow-up, both in relation to the mother and in mother-baby bonding, compared to the TAU group. Also it is expected that changes in self-compassion-related variables will explain changes in mother-fetal attachment and postpartum mother-infant bonding.

Ambulatory Childbirth Pathway Pilot Feasibility Study

In 2016, according to the national perinatal survey, the average length of stay in maternity hospitals in France after a vaginal delivery was 4.0 days, confirming the decrease in this length of stay compared with previous surveys, but placing France among the Western countries with the longest stay. Several countries that have further reduced the average length of stay offer low-risk populations a return home in the first few hours after delivery. As early as 2014, the Haute Autorité de Santé reminded us that "once low risk is defined, the length of stay in the maternity hospital is not discriminating for the safety of the mother and the newborn. The optimal length of stay would rather depend on the organization of the discharge from the maternity hospital, the medical follow-up and the subsequent support". The studies against a very early discharge are the result of experiments that do not define low risk, and/or do not propose home support. This pilot study aims to provide a framework for a care pathway allowing discharge from the maternity hospital from the 2nd hour and before the 24th hour following an uncomplicated delivery. Its main objective is to show that such a care pathway allows to respect the French postpartum recommendations, while answering a legitimate expectation of personalization of the care offered to women wishing to be monitored at home earlier after the delivery. It also studies the complications, tolerance, satisfaction and cost of such care. This is a non-randomized cohort study. It studies 100 voluntary mother-newborn couples, after a delivery at the Nice University Hospital, meeting objective criteria of low risk. A daily follow-up is ensured by a liberal midwife during the first 3 days. The link between the patient, the private midwife and the maternity hospital is maintained permanently thanks to a free dedicated mobile application. This application, equipped with an alert system, is an additional guarantee of compliance with the recommendations for screening and mandatory procedures. It allows for a safer transfer of hospital care to ambulatory care, while providing personalized care tailored to the patient's expectations. This pilot study would be the beginning of a larger study demonstrating the non-inferiority of such a care pathway compared to the most common management requiring a stay of several days in a maternity hospital.

Maternal Brain Imaging in Opioid Use Disorder

This research study aims to learn more about opioid use disorder (OUD) during pregnancy and how outcomes for pregnant women and their newborns can be improved. During pregnancy, people with OUD are prescribed medication-assisted therapy (MAT). The investigators are interested to know how the medication is broken down by the body during pregnancy and how effective it is. The investigators also want to learn if this medication and OUD have any effect on the different parts of the brain when compared to mothers without OUD.