Clinical Research Directory

Mediterranean Diet on Pregnancy and Foetus Development

The Mediterranean-style diet has been associated with longevity, long-life wellbeing, lower risk of cardiovascular disease, cancer, obesity, and metabolic syndrome. Research is pointing to the benefits that MeD could have in pregnant. Pregnancy is a very complex period and recently, the attention has been focused on the possibility that healthy dietary patterns positively influence pregnancy and the development of organs in the offspring. The mechanisms through which MeD influences pregnancy and fetal growth may partly depend on its antinflammatory properties and possibly on changes in epigenetic mechanisms. Systemic inflammation might contribute to the association between maternal obesity and less favorable neurodevelopmental outcomes. The investigators aim to define how maternal adhesion to MeD may affect pregnancy and new-born development, hence representing a notable burden from a public health and social perspective. Main objective of this project is to build up a birth cohort suitable to investigate the role of maternal dietary habits on maternal and new-born health, with special focus on MeD and its possible mechanism of action through epigenetic and inflammation changes. To establish a mother/new-born cohort, collect detailed information on maternal dietary habits and set-up a biobank of biological samples to evaluate the association between dietary habits and pregnancy outcomes. The investigators will recruit 2000 pairs (mother, new-born) in different obstetrics departments. To investigate the association between maternal dietary habits, foetal growth and offspring development and possible mediation by the inflammation profile of the mother. To understand whether maternal dietary habits are associated with epigenetic changes in the offspring and if this process is driven by the inflammation profile of the mother. Venous blood samples will be obtained at the baseline and at each gestational period for ultrasound at 11-13 gestational weeks, 20-22 weeks and 30-32 weeks. Women will be followed-up with standard clinical and 2D ultrasound examinations at gestational weeks 11-13, 20-22 and 30-32 to evaluate the fetal growth. Offspring development will be assessed at 6, 12, 18, 24 months of age. After delivery, the investigators will collect umbilical cord blood and saliva samples from new-born using standard procedures. To understand if new-born epigenetics is associated with infant physical and neurocognitive development in the following 2 years.

CHEER Oral Health in Pregnancy Study

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.

Factors Influencing Fertility or Pregnancy Health

Background: The North Carolina Early Pregnancy Study (EPS) was held from 1982 to 1986. Women who were trying to get pregnant took part in the study. They collected urine samples. They kept diaries. They filled out surveys. They answered questions about their partners. They were asked about their drug use. Data about air pollution and other exposures were also collected. A follow-up study was held from 2010 to 2011. Researchers want to use the data and samples to study factors that affect reproductive success. Objective: To examine behavioral and environmental exposures and reproductive health, such as menstrual cycles, conception, pregnancy loss, and pregnancy outcomes. Eligibility: The 221 healthy women age 21-42 who were planning to get pregnant and took part in the 1982-86 North Carolina EPS at the time they stopped using all birth control. A 2010-11 follow-up included 173 of these women. Design: This study uses existing data. No new data will be collected in this study. Stored urine samples may be used. Data from surveys and other sources will be used. All of the women who gave data and samples will be included. Electronic data is held in secure databases. The data is kept on computers that are password protected. Hard-copy data are stored in locked file cabinets. The study will take place at more than one site. Data will be shared with groups outside the NIH.

Placental Imaging Techniques

The goal of this proof-of-concept, case-control, clinical trial is to evaluate the efficacy of using two newer ultrasound technologies, quantitative ultrasound (QUS) and ultrafast power Doppler imaging (uPDI), to evaluate the health of the placenta, visualize blood flow through the placental vasculature by color Doppler imaging in singleton pregnancies with and without fetal growth restriction (FGR). * Our primary objective is to investigate the ability of using these ultrasound technologies to distinguish healthy pregnancies from those affected by FGR, a condition characterized by a fetal weight below the 10th percentile for the gestational age or abdominal circumference of the pregnancy. * Secondary aims include longitudinal evaluation of differences in QUS and uPDI imaging over gestation and changes in these measures with evolution of utero-placental insufficiency including with the development of abnormal umbilical-artery Doppler testing, diagnosis of severe FGR, identification of stillbirth, and detection of preeclampsia or preterm birth. Investigators will compare QUS/uPDI imaging and values in pregnancies determined to be healthy by approved, standard-of-care growth ultrasounds to those diagnosed with FGR. Participants will receive research ultrasounds with the experimental Verasonics Vantage 256 system (Verasonics, Inc, Kirkland, WA) utilizing uPDI/QUS every three weeks following their routine growth ultrasound evaluation until delivery. Demographic, obstetric, and delivery-related information, as well as portions of subjects' past medical history will be utilized by researchers to further contextualize imaging and variables gathered during the research ultrasounds.

Michigan Healthy Mom (MI-MOM) Pregnancy Improvement Web Application Trial

The purpose of this research study is to see if using the MI MOM App improves pregnancy and postpartum health. There are two study groups, where one group is "treatment as usual" and the other is the "MI MOM App" group. Both groups will be asked to answer questions about their pregnancy health. Researchers will also retrieve vital records and Medicaid claims information related to pregnancy for both groups. Those in the "MI MOM App" group will receive mobile web app content and text messages with informational links and links to videos and micro-interventions. They will also identify up to three close friends or family members who will be invited to receive text messages. Those in the "MI MOM App" will also have the option to contact a community health worker as needed.

Unravelling the Interplay of Weight Stigma and Pregnancy Outcomes: A Prospective Cohort Study

The goal of this prospective cohort study is to investigate the contribution of stigma and discrimination due to body size to adverse pregnancy outcomes. We also aim to explore the role of psychological and social factors in this relationship. The specific objectives of this study are: Objective 1: Explore weight stigma as a mediator of the association between BMI ≥30 kg/m2 and adverse pregnancy outcomes. Objective 2: Explore confounding factors not previously considered such as weight cycling, trauma, eating disorders, and internalised weight bias as mediators in the relationship between obesity and adverse pregnancy outcomes.

Peking University Birth Cohort in Weifang (PKUBC-WF)

The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces are also collected.

Effect of Breathing Exercises on Embryo Transfer Outcomes

Breathing exercises are being used in many different clinical issues in the area of medicine. Also in gynecological practice, especially during labor, breathing exercises are encouraged by health professionals to aid the patients. These may have benefits of process of labor as it promises attenuating the anxiety and also relaxing the pelvic muscles. IVF, which may be one of most challenging times of couples, particularly women, is reported to be related with increased anxiety. Breathing exercises may potentially help women overcome anxiety before embryo transfer, a critical step in IVF. Being an easy and non-expensive approach, breathing exercises can be recommended in every IVF clinic. Thus, the investigators wanted to observe the effects of breathing exercises on embryo transfer results.

A Culturally Adapted Digital Intervention to Promote Maternal Care Utilization Using Multifaceted Approaches

Maternal healthcare utilization is crucial for reducing maternal mortality, yet remains low in many underserved regions. The CALCIUM intervention, a culturally tailored, digital platform-integrated intervention, was developed to promote antenatal care (ANC) and institutional deliveries in Liangshan Yi Autonomous Prefecture, an ethnic minority community in China. The CALCIUM intervention was developed to address barriers including limited healthcare awareness, traditional norms and low-quality services. This intervention will evaluate the effectiveness, and cost-effectiveness of improving maternal healthcare utilization and pregnancy outcomes in an ethnic minority community.

Antenatal and Postnatal Care Research Collective - Household Survey (ARCH)

The overarching goal of the ARCH Survey is to establish a prospective longitudinal pregnancy surveillance study in Lusaka, Zambia, to precisely characterize the pregnancy rate and outcomes of women of reproductive age prior to, during, and following pregnancy and to investigate the structural, sociodemographic, and clinical covariates that contribute to adverse outcomes in each reproductive epoch.

Human Genes and Microbiota in Early Life

The long-term goal of the Human Genes and Microbiota in Early Life (HuGME) is to explore the short- and long-term effects of maternal microbiota during pregnancy and the microbiota colonization of their offspring early in life and their interaction with the host on maternal-offspring health consequences in later life in the born in Guangzhou cohort study in China. Identification of the effect of microbiota in early life, as well as environmental factors and microbe-host interaction, will lead to a better understanding of disease pathogenesis and provide a foundation for targeted mechanistic investigation into the consequences of microbial-host crosstalk for long-term health. It also can result in new strategies to predict and prevent diseases in later life.

Born In Guangzhou Intervention Study

The main objective of this study is to test the efficacy of an intervention package (dietary, physical and lifestyle modification) during pregnancy in improving the clinical outcomes of mother-infant dyads.

Impact of Uterine Immune Profiling and Personalized Treatments in Patients Receiving a Single Blastocyst: a Matched Controlled Study

A recent randomised controlled trial and previous large cohort studies have shown that the uterine immune environment is a crucial element in improving the performance of Assisted Reproductive therapy (ART). As previous studies mixed Day-3, Day-5, single or doble embryo transfer, the clear influence of the endometrial environment on the embryo itself and its type of transfer (fresh or freeze thawed) need further investigation. To complement previous studies, the present matched- pair study aims to select the population who exclusively received a single Day-5 embryo transfer (SET) and benefitted of a uterine immune profiling between 1 January 2020 and 30 June 2023 before the SET Day-5. This population will be matched to a population. who did not have uterine immune profiling in the nine months prior to the single Day 5 embryo transfer between 2018 and 2023. The matching criteria are the maternal age (+/-1 year), the past history of ART (same number of previous oocytes pick-up, same number of previous embryo transfer) and the same type of transfer (IVF, ICSI, frozen transfer) and the same category of expansion of the blastocoel (B1-B2/ B3-B4/ B5-B6). The primary end-point is the live birth rate (LBR) following the Day 5 SET in the population who benefited from pre-SET immune profiling versus the LBR following the Day 5 SET in the pair- matched population who did not benefit from pre-SET uterine immune profiling Secondary end point are the clinical pregnancy rate and miscarriage rate per SET in the two paired populations

Comparison of Pregnancy Outcomes in Women with Polycystic Ovarian Syndrome with and Without Glucophage

The goal of this clinical trial is to learn if Glucophage (metformin) improves pregnancy outcomes in women with polycystic ovarian syndrome (PCOS). It will also evaluate the safety of Glucophage during pregnancy. The main questions it aims to answer are: Does Glucophage reduce the risks of early pregnancy loss, preterm delivery, and gestational diabetes? Are there any medical problems associated with taking Glucophage during pregnancy? Researchers will compare Glucophage with standard care (diet and exercise) to see if it improves pregnancy outcomes in women with PCOS. Participants will: Take Glucophage or follow a standard diet and exercise plan throughout pregnancy. Attend regular follow-up visits for checkups, ultrasounds, and blood tests. Have their pregnancy outcomes, such as fetal growth and gestational diabetes, recorded.

Study on Fertility Parameters in Women With Germline Variants in BRCA1 and BRCA2

Pathogenic variants (PVs) in the BRCA1 and BRCA2 genes are associated with an increased risk of developing breast and ovarian cancers. According to current guidelines from the National Comprehensive Cancer Network, the risk of developing breast cancer exceeds 60% for both genes, while the risk for ovarian cancer ranges from 39% to 58% for the BRCA1 and from 13% to 29% for the BRCA2. The detection of a pathogenic variant in the BRCA1 or BRCA2 genes necessitates both the establishment of appropriate primary and secondary surveillance measures for carriers and the discussion of the familial implications of such findings. The molecular basis initially suggesting a possible association between germline variants in BRCA1 and BRCA2 genes and diminished ovarian reserve lies in the cellular impact of impaired or defective repair of DNA double-strand breaks (DSBs) on oocytes. Notably, BRCA1 and BRCA2 genes play a key role in the ATM-related mechanism for DSB repair through the homologous recombination (HR) pathway. Although preclinical evidence supports a potential correlation between defective DSB repair and normal follicle maturation processes, clinical studies on large cohorts of patients with pathogenic BRCA1 and BRCA2 variants yield inconsistent results. This discrepancy is likely attributable to the inherent challenges in recruiting a sufficiently homogeneous and statistically significant sample size. The aim of the study is to evaluate reproductive capacity in women carrying pathogenic variants in the BRCA1/2 genes by assessing the number of pregnancies during the period from January 1, 2018, to December 31, 2023. Secondary objectives include evaluating menopausal characteristics and pregnancy outcomes.

Levothyroxine Intervention in Pregnant Women with TSH （2.5 MIU/L-upper Limit of Reference Range） and Negative Thyroid Peroxidase Antibody

The goal of this clinical trial is to learn if levothyroxine (L-T4) works to treat pregnant women with TSH 2.5 mIU/L-the upper limit of reference range (ULRR) of pregnancy and TPOAb-negative. It will also learn about the safety of L-T4. The main quesitons the investigator want to answer are: * Will L-T4 reduce miscarriage rates and have an impact on pregnancy complications in pregnant participants? * What medical issues do participants have when taking L-T4 during pregnancy? -Investigators will compare L-T4 with placebo (a substance with a similar appearance without medication) to see if L-T4 could reduce miscarriage rates Participants should: * Take L-T4 or placebo during the whole pregnancy. * Visit the hospital once every 6-8 weeks during pregnancy for checkups and tests * Keep a diary of their pregncny complications and daily record of L-T4 or placebo intake. * Visit the hospital for examination 42 days postpartum for checkups and follow up by phone at 6 and 12 months postpartum.

The Born in Guangzhou Cohort Study (BIGCS)

The Born in Guangzhou Cohort Study (BIGCS) was established to investigate the short- and long-term effects of exposure in early life on health consequences in Guangzhou, China. Data are collected regarding environmental, occupational and lifestyle exposures as well as health outcomes in later life. Biological samples including blood and tissue samples are also collected from the participants.