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Pregnancy clinical trials at UCSD
4 in progress, 3 open to new patients

  • Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles

    open to eligible females ages 18 years and up

    The overarching goal of this project is to compare the microbiome profiles of healthy pregnant women, both before and after the introduction of a probiotic supplement into the maternal diet. Specifically, the investigators are performing a pilot randomized double-blinded placebo-controlled trial, comparing the microbiome profiles of 40 healthy pregnant women randomized to receive an oral probiotic containing a mixture of Lactobacillus and Bifidobacterium species (20 mothers) versus an oral placebo (20 mothers) during the first/second trimester of pregnancy. For each mother, the investigators will collect biospecimens from the vagina, rectum, and urine, both before intervention, and 4-6 weeks after intervention. These biospecimens will be analyzed to obtain their microbiome profiles using next-generation sequencing. The primary outcome of interest is the vaginal microbiome, with secondary outcomes including the microbiomes of the rectum and urine. Additionally, the investigators will collect clinical data from the mother's and infant's medical records to correlate our findings with pregnancy and postnatal outcomes.

    La Jolla, California and other locations

  • Medication Abortion Via Pharmacy Dispensing

    open to eligible females ages 15 years and up

    This mixed-methods study follows a prospective cohort of patients receiving Mifeprex ® (mifepristone) for medication abortion dispensed by pharmacists after undergoing standard clinical evaluation. Women participating in this study will obtain mifepristone and misoprostol from the pharmacy instead of in the clinic. To assess feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone, the study will survey patients, evaluate their clinical outcomes from electronic health records, and survey and interview pharmacists at study sites.

    San Diego, California and other locations

  • Stelara 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.

    La Jolla, California

  • Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)

    Sorry, not currently recruiting here

    Purpose: The objective of this proposal is to study the safety and efficacy of metformin added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women. Participants: 1200 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S. clinical centers Procedures (methods): Pregnant women with T2DM between 10 weeks and 20 weeks 6 days and a singleton fetus will be randomized to insulin/placebo versus insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical visits; blood draw at 24-30 weeks. Maternal and infant outcomes will be chart abstracted.

    San Diego, California and other locations

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