A randomized, parallel-group, double-blind and open-label, placebo-controlled, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids Save

Date Added
May 22nd, 2018
PRO Number
Pro00077125
Researcher
David Soper

Silhouette
Keywords
Obstetrics and Gynecology
Summary

Bayer is studying an investigational drug, Vilaprasin, in women who have been diagnosed with uterine fibroids, to treat heavy menstrual bleeding. Subjects will take an oral medication or placebo. Subjects will remain in the study for about 16 months and involves up to 8 visits.

Institution
MUSC
Recruitment Contact
Betty Oswald
843-792-0347
oswaldbw@musc.edu

Comparison of Length of Stay for Infants with GBS Unknown Mothers with Adequate vs Inadequate Treatment Save

Date Added
April 6th, 2018
PRO Number
Pro00077255
Researcher
Rachel Sigrest
Keywords
Children's Health, Disease Prevention, Infant, Non-interventional, Obstetrics and Gynecology, Pediatrics, Pregnancy, Women's Health
Summary

The primary investigators/residents have noted during clinical rotations that a significant number of GBS unknown mothers at SRHS are being treated with intrapartum antibiotics even without the presence of risk factors, presumably to decrease postpartum/neonatal length of stay.
Our study, a retrospective chart review, will determine whether or not length of stay is affected by treating GBS unknown mothers with intrapartum antibiotics in the absence of the aforementioned risk factors.
Potential benefits include the cost-effectiveness of decreased length of stay for these patients as well as decreased exposure to nosocomial infections for neonates. However, antibiotic stewardship and patient safety are also considerations. Another potential option for these patients is rapid GBS testing with PCR which can provide results in 1-2 hours compared with 24-48 hours for the standard culture. PCR is not currently available at SMC.

Institution
Spartanburg
Recruitment Contact
Rachel Sigrest
8643800885
racheljames1985@gmail.com

An open-label, parallel-group, randomized, multicenter study to assess the safety and efficacy of vilaprisan in subjects with uterine fibroids versus standard of care Save

Date Added
January 9th, 2018
PRO Number
Pro00068023
Researcher
David Soper

Silhouette
Keywords
Obstetrics and Gynecology
Summary

Bayer is studying an investigational drug, Vilaprasin, in women who have been diagnosed with uterine fibroids vs standard treatment.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-9302
paynej@musc.edu

Comparison of 0.1 and 0.05mg intrathecal morphine when administered with a multimodal pain regimen for post-cesarean analgesia: a single center, prospective, randomized, single-blinded trial. Save

Date Added
December 19th, 2017
PRO Number
Pro00072393
Researcher
Kathryn Bridges

Silhouette
Keywords
Obstetrics and Gynecology, Pain, Surgery
Summary

This study will compare 0.1mg and 0.05mg of spinal morphine for postoperative pain after scheduled, elective Cesarean delivery. All patients will receive a spinal anesthetic (single injection in the lower back to numb patients from the waist down) for operative anesthesia and will be
randomized into one of two groups: (group 1) 0.1mg spinal morphine and (group 2) 0.05mg spinal morphine. This will be a randomized, single blinded study.

Institution
MUSC
Recruitment Contact
Wanda Jones
843-792-1869
joneswr@musc.edu

Prospective, Non-Interventional/Observational Registry of US Uterine Fibroids Patients (Capture-US) Save

Date Added
May 16th, 2017
PRO Number
Pro00065519
Researcher
David Soper

Silhouette
Keywords
Obstetrics and Gynecology
Summary

This study is try to understand current patients with fibroids and there choices for management. We will follow women through their journey and obtain patient reported outcomes, through questionnaire's, following their current therapies for Uterine Fibroids, including symptoms, quality of life, work productivity impact, and satisfaction.

Institution
MUSC
Recruitment Contact
Jordyn DeMartino
843-792-0349
demartij@musc.edu

Chronic Hypertension and Pregnancy (CHAP) Project A Pragmatic Multicenter Randomized Trial Antihypertensive Therapy for Mild Chronic Hypertension during Pregnancy Save

Date Added
April 18th, 2017
PRO Number
Pro00063098
Researcher
Eugene Chang

Silhouette
Keywords
Obstetrics and Gynecology
Summary

The purpose of this study is to evaluate the safety and benefits of treating mild chronic hypertension (CHTN), or high blood pressure, with medication during pregnancy vs non treatment. Medication prescribed is medication currently approved to treat severe CHTN.

Institution
MUSC
Recruitment Contact
Laura Columbo
843-792-0316
columbol@musc.edu

TREETOP: A Multicenter Assessment of a Spontaneous Preterm Birth Risk predictor Save

Date Added
August 23rd, 2016
PRO Number
Pro00057002
Researcher
Scott Sullivan

Silhouette
Keywords
Obstetrics and Gynecology
Summary

The purpose of this study is to validate a test developed to determine preterm labor, to determine the optimal time to preform the test, and to discover biomarkers that will date a pregnancy and predict the time to birth.

Institution
MUSC
Recruitment Contact
Alison Line
843-792-3330
line@musc.edu

Hormone Replacement after Hysterectomy for Endometriosis: An Open Label Randomized Comparison of Conjugated Equine Estrogen (CEE) with CEE plus Bazodoxiphene (Duavee) Save

Date Added
June 9th, 2016
PRO Number
Pro00048347
Researcher
Bruce Lessey
Keywords
Obstetrics and Gynecology
Summary

The purpose of this study is to study an alternative to unopposed estrogen in premenopausal women that have endometriosis-related pain at the time of hysterectomy (removal of the womb). We will compare a type of estrogen alone with another combination medication that has the same type of estrgrogen plus another medication called bazodoxiphene (Duavee). We will compare the effect of Duavee with estrogen alone on endometriosis-associated pain scores after 6 months of therapy.

Institution
Greenville
Recruitment Contact
Cheryl Myers
864-455-5951
cmyers@ghs.org

GOG 0225: Can Diet and Physical Activity Modulate Ovarian Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival?" Save

Date Added
April 19th, 2016
PRO Number
Pro00053308
Researcher
Jeffrey Elder
Keywords
Cancer, Cancer/Gynecological, Obstetrics and Gynecology, Women's Health
Summary

Women who have completed treatment for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer and are cancer free will be randomized to either Group 1 (diet and physical activity intervention group) or Group 2 (the usual diet and physical activity group). Group 1 Intervention will include regularly scheduled lifestyle intervention coaching sessions that will be conducted over the telephone and increased physical activity. Patients will be asked to complete daily lifestyle journal that will track daily fat grams and steps. Group 2 will continue with ususal diet and physical activity and will participate in coaching phone calls. Participants will be asked to complete Patient Questionnaires. If participants consent to optional blood submission study, blood samples for research will be drawn at baseline, 3, 6,12 and 24 months from study entry. Participation will last for 24 months.

Institution
Greenville
Recruitment Contact
Gina Norris
864-241-6251
gnorris@ghs.org

A comparison of remote prenatal care versus routine in-office visits for low-risk obstetric patients Save

Date Added
November 19th, 2015
PRO Number
Pro00047817
Researcher
Donna Johnson

Silhouette
Keywords
Obstetrics and Gynecology, Pregnancy
Summary

This study will evaluate a remote patient monitoring solution for low-risk pregnancies to assess whether or not it produces equivalent care with regards to clinical outcomes and patient satisfaction at a lower cost to the healthcare system and its participants. Furthermore, we will measure the ability of participants to collect and record the necessary data.

Institution
MUSC
Recruitment Contact
Shelby Neal
843-792-4500
nealsa@musc.edu

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