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Pregnancy clinical trials at University of California Health

28 in progress, 14 open to eligible people

Showing trials for
  • Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)

    open to eligible females ages 18 years and up

    Pregnancy is associated with a increased risk of developing blood clots. There is nearly a 5 times greater risk of developing a blood clot in pregnancy. Lovenox is a medication that helps to prevent the body from developing clots. It is safe to use in pregnancy. Previous studies have demonstrated that despite recommendation of Lovenox, to prevent blood clots, the majority of patient's (70 to 90%) did not receive adequate levels of Lovenox at times throughout the day, which likely increases the risk of developing clots. The increase in blood volume and increase in kidney function that occurs in pregnancy may contribute to the inadequate levels. Currently the recommendation for pregnant and nonpregnant patients requiring Lovenox, is to calculate the daily dose of Lovenox and split the dose, giving half in the morning and the other half in the evening. This research study proposes that due to changes in the body during pregnancy that the daily Lovenox dosing be split into three times a day to achieve more consistent levels of Lovenox than twice a day in pregnant women.

    at UC Irvine

  • DETERMINE: Detemir vs NPH

    open to eligible people ages 18 years and up

    The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.

    at UCLA

  • Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study

    open to eligible females

    This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 657 Medi-Cal eligible pregnant individuals in Fresno, California. The goal is to see whether group prenatal care with wrap around services versus individual prenatal care supplemented by services covered by the California Department of Public Health Comprehensive Perinatal Services Program (CPSP) results in less depression and anxiety, and more respectful, more person-centered maternity care and lower rates of preterm birth.

    at UCSF

  • Natural Versus Programmed Frozen Embryo Transfer (NatPro)

    open to eligible females ages 18-41

    NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing frozen embryo transfer (FET) will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent).

    at UCSF

  • New Moms Mood Tracking & Wellbeing

    open to eligible females ages 18-65

    New moms can be at risk for perinatal depression (PND). The New Moms Mood Tracking and Wellbeing study is investigating mood changes, risk factors for depression and anxiety and treatment response around the time of delivery. Participants will be asked to complete three sets of online surveys between week 28 gestation and week 20 after delivery, in addition to downloading an app to collect data using their smartphone sensors and brief symptom surveys every other week. Women with elevated symptoms can participate in treatment. Women will be randomized to one of two conditions - Perinatal Psychiatric Care or Screening and Treatment for Anxiety and Depression (STAND). In Perinatal Psychiatric Care, participants will receive appointments with psychiatry clinicians. In STAND, participants will be further allocated to Online therapy with Coaching or Clinical Care, which includes both psychotherapy and psychiatry appointments. Treatment can last up to 6 months and there will be treatment related assessments for the duration of the 6 months, in addition to brief symptom surveys on a regular basis. Therefore, participation can last between 24 and 52 weeks, as both time of delivery and treatment enrollment timepoint cannot be scheduled in advance.

    at UCLA

  • Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women

    open to eligible females ages 18-65

    Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs. This rate doubles for those with adverse perinatal outcomes (APO) and triples in Black women. Recent research points to racism as one significant source of these health disparities. Cultural adaptations to improve communication with providers decrease rates of depression in minority patients as well as improve adherence to treatment, insight and alliance. Discrimination stress and worries about experiencing medical consequences are thought to increase systemic inflammation, a mechanism known to drive mental and physical symptoms. Inflammation has been implicated in both PMADs and APO, suggesting a shared underlying etiology. Evidence from our work suggests that inflammation contributes to the pathophysiology of PMADs. The proposed pilot randomized control trial will allow the investigators to build on promising preliminary results and identify whether our culturally relevant mobile Health (mHealth) intervention is effective in improving outcomes among Black pregnant women randomized to the intervention compared to a control group. The culturally relevant modules include building communication and self-advocacy skills and provide a support network. The primary objective of this research is to provide guidance for clinical care of Black women during the perinatal period, with the goal to improve mental health and physical health outcomes. A secondary goal is to examine novel inflammatory signatures that change as a function of the intervention to reduce PMADs in this population. As inflammation may be diagnostic of PMADs, identification of its role may shed light of potential intervention targets and provide critical knowledge to improve women's long-term health. PMAD symptoms will be assessed prospectively in 150 Black pregnant women, half of whom will be randomized to receive the culturally relevant mHealth intervention. The investigators hypothesize that women in the intervention group will have reduced rates of PMADs and APOs, an increase in adherence to mental health treatment and will report increased self-advocacy skills, increased communication with providers, and reduced levels of discrimination related stress. Participants will also have improved biological risk indicators including lower circulating C-reactive protein and a transcription profile of differentially expressed inflammatory genes, marked by a decreased activity of inflammatory transcription factors from blood spots. Given the high burden of both PMADs and APOs among Black mothers and the numerous consequences on maternal and child outcomes, it is imperative that investigators develop and implement effective interventions, and test the biological mechanisms that might drive these effects. This work is interdisciplinary, building on a network of community advocates to implement a novel mHealth intervention informed by real world experiences designed to enhance self-advocacy, reduce stress and prevent adverse outcomes

    at UCLA

  • Periviable GOALS Decision Support Tool

    open to eligible people ages 18 years and up

    The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a periviable delivery (deliveries occurring between 22 0/7 - 25 6/7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction.

    at UCSD UCSF

  • Expanded NIPT for Pregnancy Complications

    open to eligible females ages 18-60

    This study evaluates the utility of expanded panel non-invasive prenatal testing (NIPT) in detecting confined placental mosaicism of rare autosomal trisomies among pregnancies with placentally-mediated complications, including fetal growth restriction and severe preeclampsia.

    at UCSF

  • Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT

    open to eligible females

    The goal of this observational study is to learn about exposure to tralokinumab during pregnancy, as well as atopic dermatitis (AD) during pregnancy. The main question the study aims to answer is whether pregnant people who have been exposed to tralokinumab during pregnancy experience any differences in pregnancy and infant outcomes compared to women with atopic dermatitis who have not been exposed to tralokinumab during pregnancy. Participants are not required to take tralokinumab during the study. Participants will be asked to: - Complete 1-3 phone interviews during pregnancy and 1-2 phone interviews after delivery - Release medical records for pregnancy and for their child - Complete an online survey about their baby's development at 4 months and 12 months of age - May be asked to have a study doctor examine their child All information is collected remotely, and no visits to the study site are required.

    at UCSD

  • Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

    open to eligible females

    The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.

    at UCLA UCSD

  • Pregnancy in Women With Cystic Fibrosis

    open to eligible females ages 16 years and up

    In this study, the investigators aim to evaluate changes in lung function in women with cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators.

    at UCSD

  • Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy

    open to eligible females ages 18 years and up

    The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.

    at UCSD

  • Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

    open to eligible females

    The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

    at UCSD

  • UCLA Perinatal Biospecimen Repository

    open to all eligible people

    The purpose of this investigator-initiated prospective observational cohort study is to establish the new UCLA Perinatal Biospecimen Repository (Perinatal Repository) for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology. The secure and shared high-quality resource of clinical data and biological specimens (Repository Materials), across pregnancy pathology related to research protocols at the Afshar's Lab will be created. Core variables of interest include clinical characteristics and relevant biological samples. Intention to collect perinatal data is aiding the efficiency and effectiveness of de-identified biorepository for pregnancy-at-risk outcome research. The primary aims of the project are: - To design the Case Report Forms (CRFs) for the clinical and biospecimen data. - To create and update the project-specific policies, agreements, and Standard Operating Procedures (SOPs). - To develop the data management system to assure personal health information de-identification, data integrity, participants welfare, and protocol compliance. - To develop and implement a quality management system for the Repository. - To collect and record in the Repository protocol-related clinical information. - To organize a consistent system to bank high-quality biospecimens while protecting participant-donor safety and privacy. - To establish the policies and procedures for Repository Materials dissemination and research collaboration. - To analyze the scientific results of the Repository creation. The secondary aim of the study is to provide a mechanism to store and share for research purposes the de-identified biospecimen and information about participants at risk for adverse pregnancy outcomes.

    at UCLA

  • B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy

    Sorry, in progress, not accepting new patients

    This study will evaluate the potential placental transfer of ocrelizumab in women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (B cell levels) in the infant.

    at UCSF

  • Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN). The effectiveness of the investigational drug M281 will be measured by looking at the percentage of participants with live birth at or after gestational age (GA) 32 weeks and without a need for an intrauterine transfusion (IUT) throughout their entire pregnancy.

    at UCSF

  • CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

    Sorry, not yet accepting patients

    This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants.

    at UCSD

  • DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes

    Sorry, not yet accepting patients

    This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin. This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.

    at UCSF

  • Developing and Testing the Jenga Dada Intervention in Kenya

    Sorry, not yet accepting patients

    This study aims to work with women's economic empowerment groups within the community to address reproductive coercion and intimate partner violence and promote economic self-sufficiency among women (aged 15+ years). Based on the investigators' previous research in the United States, Bangladesh, and Kenya, the ARCHES (Addressing Reproductive Coercion in Health Settings) intervention is a highly effective clinic-based model to improve women's ability to use family planning and cope with abuse. Due to common requests for community-based support, content from the ARCHES intervention along with Girls Invest, an economic empowerment intervention implemented in the US and Nigeria, is being adapted to develop Jenga Dada, which means "Build a Woman Up" in Kiswahili, to be delivered to women's economic empowerment groups. The study will conduct formative research among women's economic empowerment group members, develop the Jenga Dada intervention, and conduct a pilot cluster randomized controlled trial to assess preliminary efficacy of the intervention on proximal outcomes (i.e., self-efficacy) and feasibility and acceptability.

    at UCSD

  • Tolerability of VeraCept IUD

    Sorry, in progress, not accepting new patients

    To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept

    at UC Davis

  • Tolerability of LevoCept

    Sorry, not yet accepting patients

    To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept

    at UC Davis

  • Healthy Moms: Prenatal Counseling for Postpartum Health

    Sorry, in progress, not accepting new patients

    See https://studypages.com/s/healthy-moms-study-765273 This individual-level randomized trial involves pregnant women followed for at least 6 months after delivery, to compare the effects of providing two "attention-control" counseling interventions designed to increase pregnant women's awareness of either: 1. the maternal health benefits of breastfeeding, or 2. the health benefits of smoke-free homes

    at UC Davis

  • Goals for Reaching Optimal Wellness: GROWell

    “We're looking for healthy pregnant people to participate in a mobile health program”

    Sorry, in progress, not accepting new patients

    Despite the negative consequences to maternal-child health from women gaining too much weight during pregnancy, up to 62% of overweight and obese women gain more pregnancy weight than is recommended. This project will establish the efficacy of Goals for Reaching Optimal Wellness (GROWell), an mHealth tool for achieving appropriate pregnancy weight gain and promoting postpartum weight loss among women who enter pregnancy overweight or obese. GROWell will fill a gap in research and clinical care by providing a validated, standalone mHealth tool for weight control during pregnancy and postpartum, which is a currently lacking resource.

    at UC Davis

  • Increasing Influenza and Tdap Vaccination of Pregnant Women

    Sorry, in progress, not accepting new patients

    Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.

    at UCLA

  • VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination

    Sorry, accepting new patients by invitation only

    COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID vaccination rates for pregnant people overall. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of increasing maternal COVID-19 vaccination rates.

    at UCLA

  • Pregnancy In the CoRonavirus (COVID-19) pandEmic

    Sorry, in progress, not accepting new patients

    Prospective nationwide cohort study of pregnant women enrolled early in gestation and followed for Covid-19 exposure and infection, with follow up of obstetrical outcomes and infant development through the first year of life.

    at UCSF

  • Attitudes and Decision-making After Pregnancy Testing Study

    Sorry, in progress, not accepting new patients

    The ADAPT Study is a longitudinal observational cohort study examining women's pregnancy preferences, pregnancy decision-making processes, and the effects of less preferred (commonly called "unintended") pregnancy on women's lives. This study will enroll and follow prospectively an Underlying Cohort (UC) of women who are not pregnant at baseline. The study will measure the degree to which participants desire to avoid pregnancy multiple times over the course of the year and capture incident pregnancies as they occur over time. Participants experiencing new pregnancies during the one-year UC will be transferred into a new cohort, the Pregnancy and Match Cohort (PMC); these women will be followed over the course of their pregnancy decision-making and health care-seeking to document these processes. In addition, they will be followed through their pregnancies and giving birth to investigate differences in health, well-being, and socioeconomic outcomes associated with carrying a pregnancy to term based on the participant's pre- and post-pregnancy preference about the pregnancy. Finally, a cohort of non-pregnant women from the UC, matched on desire to avoid pregnancy and time at risk of pregnancy, will be followed as part of the PMC. The study will compare the health, well-being, and socioeconomic outcomes of women with new pregnancies and new births to those in the non-pregnant group to assess the effect of pregnancy itself on women. The ADAPT study has the following aims: Aim 1: Assess the factors associated with women's pregnancy preferences, how preferences change over time, and their associations with contraceptive use, incident pregnancy, and feelings about the pregnancy after discovery (Underlying Cohort) Aim 2: Investigate the options that women consider when they become pregnant and the factors that influence their pregnancy decision-making and ability to access desired reproductive health care and services (prenatal, abortion, adoption) (Study A) Aim 3a: Examine the effects of giving birth from a less preferred (or "unintended") pregnancy, measured prospectively on a continuum, as compared to a more preferred pregnancy, on women's health and well-being (Study B1) Aim 3b: Examine the effects of experiencing pregnancy and birth on women's health and well-being, as compared to not experiencing pregnancy (Study B2) This is a social science, behavioral study and does not use clinical data or biological markers.

    at UCSF

  • MIRACLE of LIFE Study

    Sorry, in progress, not accepting new patients

    The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are: 1. Can cell-free RNA-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)? 2. What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?

    at UCSD

Our lead scientists for Pregnancy research studies include .

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