Obstetrics and Gynecology

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. A Study to Assess Reproductive History in Kidney Donors

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to analyze the effect of parity, menopause and reproductive lifespan on kidney structure and function.

2. Stem Cell Coated Fistula Plug in Patients With Crohn's RVF

   Rochester, Minn.

   The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with rectovaginal fistulizing Crohn's disease. Autologous means that these cells that coat the plug come from you. You will be in this study for two years. There is potential to continue to monitor your progress with lifelong regular visits as part of your standard of care. All study visits take place at Mayo Clinic and Rochester, MN. The study visit schedule is as follows: Visit 1 (Week -6) - Screening visit: exam under anesthesia and surgery to assess eligibility of fistula tract, take fat biopsy, if eligible, and fecal diversion. Visit 2 (Week 0; Day 0), exam under anesthesia for stem cell coated fistula plug placement Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8; Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (Week 52; Month 12). Visit 10 (Week 104, Month 24)

3. Predictive Role of Non-Invasive Glucose Assessment During Pregnancy

   Rochester, Minn.

   This study aims to determine the value of regular, non-invasive [glucose] LabClasp monitoring during pregnancy.

4. Prospective Identification of Long QT Syndrome in Fetal Life

   Rochester, Minn.

   The postnatal diagnosis of Long QT Syndrome (LQTS) is suggested by a prolonged QT interval on 12 lead electrocardiogram (ECG),a positive family history and/or characteristic arrhythmias and confirmed by genetic testing.  LQTS testing cannot be performed successfully before birth as   fetal ECG is not possible and direct measure of the fetal QT interval by magnetocardiography is limited. Genetic testing can be performed in utero, but there is risk to the pregnancy and the fetus. Although some fetuses present with arrhythmias easily recognized as LQTS (torsade des pointes (TdP) and/or 2° atrioventricular (AV) block, this is uncommon, occurring in <25% of fetal LQTS cases. Rather, the most common presentation of fetal LQTS is sinus bradycardia, a subtle rhythm disturbance that often is unappreciated to be abnormal. Consequently, the majority of LQTS cases are unsuspected and undiagnosed during fetal life, with dire consequences. For example, maternal medications commonly used during pregnancy can prolong the fetal QT interval and may provoke lethal fetal ventricular arrhythmias. But the most significant consequence is the missed opportunity for primary prevention of life threatening ventricular arrhythmias after birth because the infant is not suspected to have LQTS before birth. The over-arching goal of the study is to overcome the barriers to prenatal detection of LQTS. The investigators plan to do so by developing an algorithm using fetal heart rate (FHR) which will discriminate fetuses with or without LQTS. Immediate Goal: The investigators propose a multicenter pre-birth observational cohort study to develop a Fetal Heart Rate (FHR)/Gestational Age (GA) algorithm from a cohort of fetuses recruited from 13 national and international centers where one parent is known by prior genetic testing to have a mutation in one of the common LQTS genes: potassium voltage-gated channel subfamily Q member 1 (KCNQ1), potassium voltage-gated channel subfamily H member 2 (KCNH2), or sodium voltage-gated channel alpha subunit 5 (SCN5A). The investigators have chosen this population because 1) These mutations are the most common genetic causes of LQTS, and 2) Offspring will have high risk of LQTS as inheritance of these LQTS gene mutations is autosomal dominant. Thus, progeny of parents with a known mutation are at high (50%) risk of having the same parental LQTS mutation. The algorithm will be developed using FHR measured serially throughout pregnancy. All offspring will undergo postnatal genetic testing for the parental mutation as the gold standard for diagnosing the presence or absence of LQTS.

5. Establishment of Preclinical Models from Patients with Gynecological Malignancies

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   Effective treatments for recurrent gynecological cancer are lacking, and there is a need for novel therapeutic options. One of the barriers to improving outcomes in this subgroup of patients is the paucity of tumor models that can mimic patient characteristics to study novel therapies. Patient-derived xenograft (PDX) models are considerate the most representative pre-clinical model of human cancer, recapitulating the key characteristics of the original patient tumor. Other preclincal models to test drug effcicacy includes ex vivo 3D culture and 2D culture systems. In this study, we make and test preclinical models of gynecological cancers (ovarian, fallopian tube, peritoneal, uterine, vulvar, cervix, and vaginal) of any histologic subtype using surplus tumor specimens obtained at the time of routine tumor biopsy procedure, or clinically-indicated surgery.

6. A Study of Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples

   Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to collect vaginal and endometrial cell samples to study endometrial cancer.

7. A Study to Evaluate Time to First Movement for Fetal Surgery Patients Injected with Intramuscular Anesthesia

   Rochester, Minn.

   The purpose of this study is to determine the time from intramuscular injection to the time of first fetal movement after a fetal surgery procedure.

8. Mayo Clinic Umbilical and Placental Tissues Biobank

   Rochester, Minn.

   The purpose of this study is to collect paired maternal and umbilical cord blood samples that can be processed for various traits in the blood, including serum, DNA, RNA and cells. The long term goal of this project is to start an Umbilical and Placental Tissues Biobank, which will operate in parallel to the Mayo Clinic Biobank. In future studies, we may use the serum, DNA and RNA obtained from cord blood and your blood to understand health and disease.

9. Creation of PLACENTA/Serum Repository Database: Autoimmunity from Mother To Baby Study

   Rochester, Minn.

   The purpose of the study is to learn more about autoimmunity and potential mother to baby transmission of pathogenic antibodies. The collected research samples from children will be frozen and stored at the Mayo Clinic and will be used for future studies of autoimmune diseases.

10. A Study to Assess Maternal and Fetal Outcomes in Pregnancy with Type 1 Diabetes Mellitus and Controls

    Rochester, Minn.

    The purpose of this study is to retrospectively and prospectively compare maternal and fetal/newborn clinical outcomes in age-matched pregnant patients with T1D and healthy controls and to assess the relationship between glycemic variability and pregnancy outcomes in the current era.