Cepheid / "Clinical Evaluation of Xpert Xpress GBS Test" Save

Date Added
May 26th, 2020
PRO Number
Pro00096391
Researcher
Ashlyn Savage

List of Studies


Profiles_link
Keywords
Obstetrics and Gynecology
Summary

This study is to develop a rapid molecular diagnostic test for the detection of Group B Strep (GBS). This study will collect specimens from pregnant women for the development of a prototype assay.

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

ATHN 9: A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment for People With Severe Von Willebrand Disease (VWD) Save

Date Added
January 27th, 2020
PRO Number
Pro00092790
Researcher
Stephanie Ambrose

List of Studies

Keywords
Adolescents, Blood Disorders, Children's Health, Circulation, Dental, Genetics, Infant, Joint, Men's Health, Minorities, Muscle, Non-interventional, Nose, Obstetrics and Gynecology, Pain, Pediatrics, Periodontal Disease, Rare Diseases, Rheumatoid, Surgery, Women's Health
Summary

ATHN 9 is a natural history study to assess the safety of various Von Willebrand Factor (VWF) regimens for different indications (on-demand, surgery and prophylaxis) in adult and pediatric participants with clinically severe congenital VWD.

Institution
Palmetto
Recruitment Contact
Shannon Cearley
803-434-4088
shannon.cearley@prismahealth.org

Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring (PHANTOM) Save

Date Added
December 18th, 2019
PRO Number
Pro00095709
Researcher
Matthew Finneran

List of Studies

Silhouette
Keywords
Obstetrics and Gynecology
Summary

We are comparing standard in-office postpartum blood pressure monitoring to at-home monitoring for patient diagnosed with hypertensive disorders of pregnancy.

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

Medication treatment for Opioid use disorder in expectant Mothers (MOMS): a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations Save

Date Added
August 27th, 2019
PRO Number
Pro00091146
Researcher
Constance Guille

List of Studies


Profiles_link
Keywords
Obstetrics and Gynecology, Pregnancy, Psychiatry, Substance Use, Women's Health
Summary

The primary purpose of this study is to compare extended-release buprenorphine (CAM2038) to buprenorphine placed under the tongue (sublingual) in pregnant women with opioid use disorder to see if CAM2038 is as effective as sublingual buprenorphine. We are looking to recruit pregnant women who are between 18-41 years old; are between 6-30 weeks pregnant and are not planning to terminate the pregnancy; have opioid use disorder, and are enrolled or are planning to enroll in outpatient buprenorphine treatment at The Medical University of South Carolina. Participation in the study would last between 13 and 21 months total with up to between about 63-102 total visits, including weekly medication check visits and research visits.

Institution
MUSC
Recruitment Contact
Savannah Lee
8437920376
leesav@musc.edu

Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS) Save

Date Added
August 26th, 2019
PRO Number
Pro00089639
Researcher
Heather Jackson

List of Studies

Keywords
Children's Health, Obstetrics and Gynecology
Summary

This study will involve 12 babies who have been identified as at risk for withdrawal symptoms after birth. This study will test the feasibility of acupressure as an additional non-invasive, first line treatment for infants experiencing withdrawal symptoms. We will also send a voluntary survey out to the healthcare providers who cared for the infant (nurse, medical doctor, or advanced practice provider (nurse practitioner or physician assistant).

Institution
MUSC
Recruitment Contact
Heather J Jackson
6156910545
heather.jackson@vumc.org

AMAG-423-201: A Phase 2b/3a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of AMAG-423, a Digoxin Immune Fab, in Antepartum Subjects with Severe Preeclampsia Save

Date Added
August 13th, 2019
PRO Number
Pro00089350
Researcher
Scott Sullivan

List of Studies


Profiles_link
Keywords
Obstetrics and Gynecology
Summary

This study aims to show the safety and effectiveness of AMAG-423, an IV medication, in women with severe preeclampsia. The purpose of this study is to see how well AMAG-423 might work to prevent some of the most serious complications in premature babies, as well as improve symptoms of preeclampsia. Women will be admitted with this diagnosis and receive IV medication, AMAG-423, every 6 hours for up to 4 days. Subjects will be followed through out their hospital stay and up until their post partum 6 week check. The only treatment for severe preeclampsia is delivery.

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

A Phase 3, Multi-center, Prospective, Randomized, Placebo-Controlled, Delayed Treatment, Double-Blind Study to Evaluate the Effectiveness and Safety of a Single Oral Dose of SolosecTM Granules Containing 2 grams of Secnidazole for the Treatment of Trichomoniasis Save

Date Added
July 23rd, 2019
PRO Number
Pro00088644
Researcher
Gweneth Lazenby

List of Studies


Profiles_link
Keywords
Obstetrics and Gynecology
Summary

The purpose of this research study is to test the safety and effectiveness of an investigational drug (Solosec) for the treatment of trichomoniasis. Solosec was approved in the United States by the Food and Drug Administration (FDA) in 2017 for the treatment of bacterial vaginosis (BV) in adult women ages 18 years and older. The sponsor would like to gather additional information for the treatment of Solosec in adult women and girls ages 12 years and older diagnosed with trichomoniasis.

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

Evaluation of the Women's Reproductive Behavioral Telehealth (WRBT) Program Save

Date Added
April 4th, 2019
PRO Number
Pro00086783
Researcher
Constance Guille

List of Studies


Profiles_link
Keywords
Mental Health, Obstetrics and Gynecology, Pregnancy, Psychiatry, Women's Health
Summary

Staff at sites who participate in the MUSC Women's Reproductive Behavioral Telehealth (WRBT) Program will be asked to participate in individual interviews or focus groups (group discussions) about their experience with the telemedicine program and fill out surveys. Patients in the WRBT Program will be asked to fill out surveys about their telemedicine experience.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-0403
douglaed@musc.edu

Specimen Procurement for NeuMoDx™ Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) Assay Evaluation Save

Date Added
March 6th, 2019
PRO Number
Pro00084622
Researcher
Gweneth Lazenby

List of Studies


Profiles_link
Keywords
Obstetrics and Gynecology
Summary

The purpose of this research is to provide the sponsor vaginal and urine samples that the clinician has collected and the subject has self collected in order to study a new test being developed for the detection of Chlamydia trachomatis and
Neisseria gonorrhoeae.

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

Web-Based Treatment for Perinatal Opioid Use Disorder Save

Date Added
March 2nd, 2019
PRO Number
Pro00085580
Researcher
Constance Guille

List of Studies


Profiles_link
Keywords
Mental Health, Obstetrics and Gynecology, Pregnancy, Psychiatry, Substance Use, Women's Health
Summary

This purpose of this research study is to collect feedback from participants about a web-based program for opioid misuse and opioid use disorder. Participants will be asked to review web-based content and take part in focus groups (group discussions) and individual interviews to provide feedback on the content. The study team is looking for pregnant women or women who have been pregnant in the past 2 years who misuse opioids or have opioid use disorder, as well as obstetric providers who treat pregnant women with opioid misuse and opioid use disorder to participate.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-0403
douglaed@musc.edu

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