Clinical Research Directory

HappyMums Mobile Application Study

The goal of this study is to investigate whether pregnant people at risk of, or currently suffering from antenatal depression, find it acceptable to use the 'HappyMums' mobile application during their pregnancy. This app will collect data relevant to their mental health passively and through active engagement from the user. After the study is complete, these data will be put together to determine if such data types could be used in future to help predict and identify antenatal depression, and aid better treatment decisions.

The Effect of Podcast Training on Birth Fear in Couples

Birth fear refers to intense feelings of anxiety, fear, and worry regarding the childbirth process, often arising from concerns about physical pain, complications, or uncertainty about the baby's health. Many women experience this fear during pregnancy, which, in some cases, may develop into a clinical condition known as tokophobia . Birth fear can increase stress levels, disrupting the mother's hormonal balance, which may prolong labor, increase the risk of complications, and negatively impact fetal development. Additionally, it can lead to issues such as loss of self-confidence, anxiety, and depression in the mother, while causing communication problems and lack of support between partners. Birth fear affects not only the labor process but also the postpartum period, potentially leading to postpartum depression, trauma, and difficulties in mother-infant bonding. All these factors can adversely impact the psychosocial well-being of both women and couples. Therefore, it is crucial to develop interventions aimed at recognizing and reducing birth fear.

Justice Core Trial

The goal of this clinical trial is to learn if Justice Core, an intervention that moves pregnant women with substance use disorder (SUD) from jail into community-based SUD treatment while awaiting trial, can improve the health of pregnant women compared to referring them to treatment at the time of jail release. The main questions it aims to answer are: * Will the Justice Core intervention help women start and stay in SUD treatment compared to a group of women being given a treatment referral when they leave the jail? * How does the Justice Core intervention affect pregnancy health outcomes compared with a group that is given a treatment referral when they leave the jail? * What are the challenges in starting a new intervention, keeping it running, and the ethical issues during and after the trial? Researchers will compare the outcomes of women who receive the Justice Core intervention with women who receive a treatment referral when they are released from jail. They will look at how many women start and continue treatment and compare pregnancy-related and incarceration outcomes. Participants will be asked to: * Complete a treatment assessment. * Take part in three follow-up phone surveys. * Some participants may also be asked to complete a longer phone interview to share more about their experiences.

Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females

Maternal iron deficiency (ID) and iron deficiency anemia (IDA) is associated with maternal and infant mortality, spontaneous preterm birth, maternal postpartum hemorrhage, and neurocognitive defects in the neonate. Therefore, preventing maternal IDA in at-risk women is critical. The standard approach to improving iron status in pregnancy (i.e., oral iron supplements) is suboptimal and gastrointestinal discomforts associated with this approach (i.e., constipation) impairs adherence. The incidence of ID (18%) and IDA (5%) in pregnant populations suggest alternative interventions are needed to optimize iron status in pregnancy. There is increasing evidence that consuming the probiotic Lactoplantibacillus plantarum 299v (LP299V®) can enhance dietary non-heme iron absorption by changes in the composition and metabolic patterns of gut microbiota that reduce intestinal pH, enhance mucin production and favor an anti-inflammatory milieu. This immunomodulatory effect may be important because inflammation stimulates hepatic production of hepcidin, a master regulator of systemic iron homeostasis, which inhibits iron flow into circulation from diet and body stores. Further, the effects of LP299V® may extend to the placenta. The investigators' team showed previously that maternal iron deficiency is associated with changes to placental iron metabolism with more iron sequestered in the placenta and less iron transferring to the fetus. Given its positive effects on maternal iron status, the investigators surmise that LP299V® supplementation will result in higher placenta protein expression of iron transporters, transferrin receptor-1 and ferrroportin-1, and lower placental iron accumulation/content. The primary goal of this study is to test the efficacy of this low-cost, safe, innovative approach to optimizing maternal iron status in individuals at risk for ID in pregnancy \[Hb 11.0 - 11.9 g/dL (first trimester) and Hb 10.5 - 11.5 g/dL (second trimester) based on new OB clinical complete blood count (CBC) results obtained from the EHR\] from 10-16 weeks gestational age (GA) until the time of labor. The investigators will also test the effects on neonatal (cord blood) iron status and (cord blood + newborn heel stick) Hb at birth and determine the effect of maternal LP299V® supplementation on the maternal gut microbiome, hepcidin-ferroportin axis and placenta iron and placenta transport of iron as its primary mechanisms of action. Finally, the investigators will explore the effect of maternal LP299V® supplementation on infant neurodevelopment at birth. This study is an essential first step toward evaluating if twice daily oral LP299V® is an efficacious, safe, inexpensive, and scalable clinical strategy for the prevention of maternal ID and its related complications in at-risk women.

Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women

Purpose of this Study: The main purpose of this study is to adapt an existing evidence-based intervention, Project Accept Post-Test Support Services (PTSS) Module 3, specifically for pregnant and postpartum women living with HIV (WLWH) in Ghana. The adapted intervention aims to reduce HIV-related stigma and improve adherence to antiretroviral therapy (ART) and mental health symptoms, such as depression and anxiety, among this vulnerable population. Why was this study done? (Background): HIV-related stigma is a major obstacle for women living with HIV, particularly pregnant women in Sub-Saharan Africa (SSA), hindering their engagement in HIV care and adherence to ART. This contributes to poor health outcomes, including inadequate viral suppression, depression, and an ongoing risk of HIV transmission to their children and sexual partners. While effective HIV stigma-reduction interventions exist for the general adult population living with HIV, there is a critical lack of tailored interventions for pregnant and postpartum WLWH in SSA. This study addresses this gap by adapting a proven intervention (Project Accept PTSS Module 3), which has shown success in reducing stigma and improving outcomes in other populations, for this specific group in Ghana, where HIV-related stigma remains disproportionately high. Who participated in this study? (Target Population): This study will involve several groups: Pregnant and postpartum women living with HIV: 30 women will participate in in-depth interviews to share their experiences with stigma and HIV care. HIV care providers: 20 providers will participate in in-depth interviews to offer their perspectives on stigma and care provision. Stakeholders: This group will include HIV care providers, program administrators/directors, and pregnant and postpartum women. They will collaborate in the iterative process of adapting the intervention. Pregnant women living with HIV (for feasibility testing): 90 pregnant women will be randomized, with half receiving the adapted intervention and half receiving standard care, to assess the intervention's feasibility, acceptability, and preliminary impact. What happened in this study? (Intervention/Methods): This 3-year study has three main aims: Understanding Stigma Experiences: Researchers will describe the experiences of stigma and HIV care from the perspectives of pregnant and postpartum WLWH and compare them with providers' experiences. This will involve longitudinal data collection and in-depth interviews to understand how stigma affects women's health, clinical care (e.g., provider discrimination, ART adherence), and mental health over time. Intervention Adaptation: Project Accept PTSS Module 3 will be adapted specifically for pregnant and postpartum WLWH using the ADAPT-ITT framework. This involves an iterative process with stakeholders to ensure the intervention is culturally and gender-appropriate, enhancing its acceptability for the target population. Feasibility and Preliminary Impact Assessment: The study will assess the feasibility and acceptability of the adapted intervention. Ninety pregnant women will be randomly assigned to either receive the intervention or continue with standard care. Researchers will then estimate the intervention's potential impact on anticipated and internalized HIV-related stigma (primary outcomes), as well as ART adherence and symptoms of anxiety and depression (secondary outcomes). What were the results of this study? (Outcomes): As a preliminary and adaptation study, this research aims to: Provide essential data to inform and justify a larger, fully-powered randomized clinical trial to rigorously evaluate the adapted intervention's effectiveness. Identify potential indicators associated with mother-to-child transmission of HIV. Develop a model that can be applied to other Sub-Saharan African countries facing similar challenges. Foster new collaborations focused on HIV-related stigma among women in Ghana. Build research capacity among researchers in sub-Saharan Africa. What are the side effects of the treatments in this study? (Safety): This study focuses on a behavioral intervention (a support and counseling module) rather than a drug or medical treatment. Therefore, typical physical side effects associated with medications are not expected. The intervention aims to improve well-being and health outcomes by addressing psychosocial factors. Any adverse events or discomfort experienced by participants will be carefully monitored and addressed in accordance with ethical guidelines. What are the conclusions of this study? (Implications/Future Plans): The findings from this study are expected to demonstrate the feasibility and potential impact of a culturally and gender-tailored HIV stigma-reduction intervention for pregnant and postpartum WLWH in Ghana. This research will be foundational for launching a larger-scale clinical trial to definitively test the intervention's efficacy.

Effectiveness of 10% Lidocaine on Relieving Pain Caused by Intravenous Intubation

The goal of this clinical trial is to learn if 10% Lidocaine spray can reduce local pain caused by intravenous (IV) intubation among women. The main questions it aims to answer are: * Does 10% Lidocaine spray lower the VAS score in participants need intravenous intubation? * What size effect of 10% Lidocaine spray when patients administered? Researchers will compare 10% Lidocaine spray to a placebo (a look-alike substance that contains no drug) to see if 10% Lidocaine spray works to reduce local pain caused by intravenous (IV) intubation Participants will: * Receive 3 spray of 10% Lidocaine at intravenous catheter insertion site before the nurse perform the IV insert procedure * Assess the pain cause by IV insertion using VAS

Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

This study collects obstetric ultrasound images from pregnant participants using the UIH uSONIQUE Nova diagnostic ultrasound system (uC7-1s transducer). The goal is to obtain standardized, high-quality images to support artificial intelligence (AI) algorithm development, AI training and validation, and automated obstetric measurement workflows. Results will support a premarket notification (510(k)) submission to the U.S. FDA.

Routine Iron Prophylaxis During Pregnancy

Comparison of two policies of iron administration during pregnancy in regard to health and program feasibility in an area with endemic malaria and high prevalence of HIV infection. The policies are: 1) routine iron prophylaxis, 2) screening and therapy with iron.

Vitamin D3 and Monocyte Responses in Pregnant Women With Pulmonary Tuberculosis

This randomized controlled trial evaluated the effects of adjunctive vitamin D3 supplementation on circulating monocyte subsets and the expression of vitamin D receptor (VDR) and interleukin-6 (IL-6) in pregnant women with pulmonary tuberculosis. A total of 32 pregnant women with pulmonary tuberculosis were allocated to receive either standard first-line anti-tuberculosis treatment alone or standard treatment plus oral vitamin D3 supplementation at a dose of 50,000 IU once weekly for eight weeks. Serum 25-hydroxyvitamin D \[25(OH)D\] concentrations, monocyte subset distributions, and monocyte expression of VDR and IL-6 were assessed at baseline, approximately eight weeks after enrollment, and during the early postpartum period. Monocyte subsets were characterized by CD14 and CD16 expression using flow cytometry. The study aimed to investigate whether adjunctive vitamin D3 supplementation modifies vitamin D status and monocyte-related immunological responses in pregnant women receiving treatment for pulmonary tuberculosis.

Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics

The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL) against usual antenatal care on a composite adverse pregnancy outcome including low birth weight, small for gestational age, preterm, fetal loss, or neonatal death.

Blind Measurement in Fetal Weight Estimation

Woman who are expected to give birth in the next 72 hours will be allocated randomly to a study group of blinded measurements for estimated fetal weight and a control group of non-blinded measurements. Accuracy of estimations will be compared between the groups.

Mandala Coloring in Late Pregnancy

Anxiety, depression and poor sleep are common in the last months of pregnancy and often occur together. Medication options during pregnancy are limited, so simple, safe non-drug methods are needed. Mandala coloring is an art therapy technique in which a person colors circular patterns; it helps focus attention on the present moment and may have a calming effect. This randomized controlled trial will examine whether mandala coloring during the third trimester reduces depression, anxiety and stress, improves sleep, and reduces fear of childbirth. It will also look at birth outcomes and the childbirth experience. Pregnant women at 28 weeks of gestation who attend the obstetrics outpatient clinics of Malatya Training and Research Hospital will be randomly assigned to a mandala coloring group or a control group. Women in the mandala group will color two mandalas a week at home for 8 weeks (16 mandalas in total, about 20-30 minutes per session). Women in the control group will receive routine antenatal care only and will be offered the mandala materials after the study ends.

Effect of Birth Dance on Birth Beliefs

This randomized controlled study was conducted to determine the effects of birth dance on birth beliefs, perceptions of supportive care needs, and anxiety levels in primiparous women. The study will be conducted with primiparous women in the experimental and control groups. The Birth Beliefs Scale, the Scale of Women's Perception for Supportive Care Given During Labor (SWPSCDL), and anxiety level assessments will be used to evaluate outcomes. The relationship between birth beliefs and anxiety levels will be examined.

Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient

This is a randomized, open-label, single-center clinical trial. The purpose of the study is to understand whether the aid of ultrasound assessment is useful in improving the competence of resident. Specifically, to demonstrate how the aid of echo-assistance in the evaluation of the spine increases the atraumatic success rate (primary objective) and reduces the number of complications (particularly, the number of attempts needed and the rate of dura puncture) (secondary objective) in physicians in specialty training. Pregnant patients requiring peridural analgesia will be assigned to the intervention or control group by simple randomization.

Mobile Assisted Education on Prenatal Health

This study aims to evaluate the effect of mobile-assisted education on prenatal health literacy, health behaviors, and childbirth outcomes among primigravida women

Gestational Weight Loss and Restrictive Weight Gain in Maternal Obesity: A Target Trial Emulation

This study asks whether the current weight-gain guideline for pregnant people with obesity should be lowered, and whether the answer depends on how severe the obesity is. The guideline from the Institute of Medicine (IOM) recommends that all pregnant people with obesity gain 5.0 to 9.0 kg, regardless of obesity class. However, growing evidence suggests that people with Class II or III obesity may benefit from gaining less than this range-or even losing a small amount of weight-without harming the baby. A randomized trial to test this directly would be ethically and practically difficult, so this study uses a different approach: it reconstructs what such a trial would have shown, using nationwide U.S. birth records. The study uses 2024 U.S. birth certificate data for people with pre-pregnancy obesity who had a single live birth. It compares three weight-gain patterns during pregnancy: (1) net weight loss (less than 0 kg gained), (2) restrictive gain (weight gained, but below the dynamic, gestational-age-specific IOM lower bound), and (3) standard gain within the IOM-recommended range. The main questions are whether restrictive gain or weight loss, compared with standard gain, reduces the risk of hypertensive disorders of pregnancy (such as gestational hypertension and preeclampsia) while not increasing the risk of a baby born small for gestational age (SGA). The study also examines whether the balance of benefits and harms differs across Class I, Class II, and Class III obesity. This is an observational study, not a randomized trial. It does not enroll participants or provide treatment. All analyses use existing, de-identified public health data. Results are intended to inform whether future weight-gain guidelines should provide class-specific recommendations rather than a single range for all obesity classes.

Comparison of Beta-hCG Levels When Using Venous Puncture Blood and Peripheral Finger Stick Blood

The objective of his study is to quantitatively evaluate a patient's pregnancy status using their beta-hCG levels when using venipuncture blood vs peripheral blood.

Impact of Standardization on Outcomes Following Cervical Ripening

The primary purpose of this study is to determine if vaginal delivery rate is impacted by the use of standardized methods of cervical ripening. Additional outcomes will be evaluated including maternal and fetal outcomes of labor.

Pregnancy Anti-inflammatory Diet Intervention Study

Dietary patterns may influence maternal inflammatory status and pregnancy outcomes. However, structured anti-inflammatory dietary interventions specifically designed for pregnant women remain limited. This study aims to develop and evaluate an evidence-based, theory-informed anti-inflammatory dietary intervention to improve dietary habits and reduce dietary inflammatory potential during pregnancy. The intervention will be developed through evidence synthesis, qualitative research, and expert consultation, guided by the the Behaviour Change Wheel. Following intervention development, a randomized controlled trial will be conducted to assess its feasibility, acceptability, and preliminary effects. Pregnant women will be randomly assigned to an intervention group receiving individualized anti-inflammatory dietary guidance and behavioral support or a control group receiving routine antenatal care. Outcomes will include intervention feasibility, dietary inflammatory potential, maternal inflammatory biomarkers, and relevant pregnancy-related outcomes. The findings will inform further refinement of the intervention and provide evidence for future research.

Evaluating the Healthy Families PrEP Program for Women at Risk for HIV

Study investigators developed and piloted a counselling intervention, Healthy Families-PrEP, that supports women to use HIV prevention strategies while trying for and during pregnancy. They will now adapt the intervention to community clinics and postpartum women and test the intervention. The goal is to reduce HIV incidence among women and children.

Effect of Birthing Stool Use During Labor on Birth Comfort, Perceived Support and Control

This study was planned to determine the effect of using a birthing stool during labor on birth comfort, perceived support and control during labor in primiparous pregnant women. H1: Primiparous pregnant women who use a drape during labor have higher birth comfort compared to those who do not. H2: Primiparous pregnant women who use a drape during labor have higher levels of birth control and support compared to those who do not. H3: Primiparous pregnant women who use a drape during labor have shorter labor durations compared to those who do not.

Maternal Inborn Errors of Metabolism in Pregnancy: A Pregnancy Registry Protocol

Background: \- People with inborn errors of metabolism can t turn food into energy the right way. This can affect a person s growth and health. Researchers want to know how this condition affects a pregnant woman and her baby. Objectives: \- To collect data from the medical records of women with an inborn error of metabolism. Also, to create a pregnancy registry of inborn errors of metabolism. Eligibility: * Women with an inborn error of metabolism who either: * have been pregnant in the past, * are currently pregnant, or * have recently talked with their doctor about becoming pregnant. Design: * This study will collect data only. No extra tests will be done. * Participants will be in the study for the length of their pregnancy and for 1 year after delivery. * Participants will answer questions about their family s health. * The participant s doctor will send their medical records to researchers. These may include data about: * Last health care visit before pregnancy * Blood, urine, ultrasound, or lab results during pregnancy * Delivery and recovery after delivery * Researchers will ask for the test(s) used to confirm pregnancy. * After the participant has her baby, researchers will ask for data about how the baby is doing. This may include when the baby is sitting, walking, talking, etc. * The data will be placed into a database. The database will not include the participant s name or identifying data.

Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test

Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial center and provide a sample of urine from the same void for further testing. Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.

Calcium Carbonate on Labor Induction

The investigators aim to evaluate the safety and efficacy of administering calcium carbonate to laboring participants undergoing labor inductions. The investigators hypothesize that calcium carbonate is a low-risk preventative measure to decrease oxytocin induction time and dosage, decrease the rate of labor dystocia, decrease the rate of cesarean deliveries, and demonstrate no differences in maternal or neonatal safety outcomes.