Changes in Optic Nerve Sheath Diameter in Preeclamptic patients with Severe Features by Neurologic Criteria versus Diagnosis Without Neurologic Criteria, Compared to Controls. Save

Date Added
November 7th, 2018
PRO Number
Pro00078977
Researcher
Mary Sterrett
Keywords
Central Nervous System, Hypertension/ High Blood Pressure, Non-interventional, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Preeclamptic patients will have an ultrasound done of their eyes, to look at the size of the nerve behind the eye. We will also recruit women without preeclampsia to be a comparison group.

Institution
MUSC
Recruitment Contact
Mary Sterrett
8434940554
sterretm@musc.edu

A Randomized Controlled Trial of Playing "The Most Relaxing Song in the World" During Labor Epidural Placement and its Effects on Anxiety and Satisfaction. Save

Date Added
October 3rd, 2018
PRO Number
Pro00078958
Researcher
David Gutman
Keywords
Obstetrics and Gynecology
Summary

We propose to play the song "Weightless" during epidural placement on an iPhone set to medium volume. The song (all 6 continual parts) is 43 minutes long and will be started just before epidural placement and stopped just after end of procedure. The control group will be expectant mothers who do not have "Weightless" playing during their epidural placement. The goal is to determine if playing "the most relaxing song in the world" helps to reduce laboring parturients anxiety and improve their overall satisfaction with the experience.

Institution
MUSC
Recruitment Contact
Christine Aanstoos
843-792-1869
aanstoos@musc.edu

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
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
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
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
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
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
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

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