Active clinical trials for Obstetrics & Gynecology:

TITLE DESCRIPTION
Blood Loss during fibroid surgery Use of Intravenous Tranexamic Acid during Myomectomy: A Randomized Double-Blind Placebo Controlled Trial The goal of this study is to help us learn more about the ability of a drug called tranexamic acid to reduce blood loss and the need for a blood transfusion that occurs during a myomectomy (fibroid surgery). Tranexamic acid is approved for patients undergoing cardiac, knee and hip surgery by the FDA but yet not approved for the indication of myomectomy surgery as being investigated in this study. The research team would like to enroll healthy women between 18 and 50 years of age; with no history of blood clots in the legs or lungs, heart attack, stroke or kidney disease and scheduled for an abdominal, laparoscopic or robotic myomectomy at George Washington University Hospital.
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Fetal Vasoreactivity in normal pregnancy This study is being performed at Children's National Health System. We are trying to understand how the normal fetus controls blood flow to the different parts of the body such as the lungs and brain. We will measure your baby’s blood flow using the same ultrasound approach used by your obstetrician. We will test your baby’s control of blood flow by measuring the responses to changes in your (the mom’s), levels of oxygen and carbon dioxide. We will make these changes by asking you to breathe extra oxygen for short periods of time. If your obstetrician determines that your pregnancy is uncomplicated, you and your baby are eligible for this study.
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Placental Perfusion Imaging Using Arterial Spin Labeled MRI In this study, we are developing non-invasive tools to identify early signs of abnormalities of the placental function using arterial spin labeling (ASL) based on fetal MRI. ASL is a particularly attractive method for early and safe monitoring during pregnancy given that ASL is completely non-invasive and does not require contrast agents or exposure to ionizing radiation. Our specific aim is to develop and validate placental perfusion imaging with substantially improved image quality and sensitivity to abnormalities.
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Prevention of Postpartum Hemorrhage: Pharmacokinetics and Pharmacodynamics of Tranexamic Acid Tranexamic acid was shown to significantly reduce risk of mortality when given to women with diagnosed postpartum hemorrhage in the recent Lancet WOMAN Trial.* The purpose of this study is to determine the optimal dose for using tranexamic acid to prevent postpartum hemorrhage during routine cesarean section. Women must be at risk for postpartum hemorrhage to enroll and must not have a history of blood clots or a known clotting condition. *http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31111-X/fulltext
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Randomized Controlled Trial: Physical Exam Indicated Cerclage in Twin Gestations Women with twin pregnancy who have a dilated (open) cervix detected on physical exam before 24 weeks are at increased risk for delivering their babies preterm (before 37 weeks gestation). Prematurity is associated with many complications for the babies including respiratory (breathing) problems, bleeding inside of the brain (a form of stroke), increased risk of infection, kidney, temperature and feeding problems. The primary objective of this study is to determine if physical exam indicated cerclage use reduces the incidence of spontaneous PTB in asymptomatic women with twin gestations with cervical dilation diagnosed on pelvic exam before 24 weeks of gestation.
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Sonography-Guided Transcervical Ablation of Uterine Fibroids (SONATA) [This study is no longer recruiting.] The SONATA Study is an FDA-approved clinical study designed to establish the safety and effectiveness of a new, investigational device to reduce heavy menstrual bleeding caused by uterine fibroids. The device, called the SONATA System, targets fibroids rather than treatment or removing the entire uterus. If effective, this device will provide an alternative to hysterectomy that is: incision-free, preserves the uterus, does not require general anesthesia and is an outpatient procedure.
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Vaginal vs Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth Preterm birth is one of the leading causes of neonatal morbidity and mortality. One of the most significant risk factors is a history of a prior spontaneous preterm birth. Intramuscular progesterone is the only FDA approved medication for the prevention of recurrent preterm birth. Vaginal progesterone is not FDA approved for the prevention of recurrent preterm birth, but has been found to beneficial. Given the presence of trials demonstrating efficacy for both intramuscular and vaginal progesterone in the prevention of recurrent preterm birth, but limited information one being more superior to the other, we are performing a trial comparing vaginal progesterone and intramuscular progesterone for the prevention of recurrent spontaneous preterm birth in women with a history of prior spontaneous preterm birth.
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