A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF SAGE-217 IN THE TREATMENT OF ADULTS WITH SEVERE POSTPARTUM DEPRESSION

Date Added
September 8th, 2020
PRO Number
Pro00101329
Researcher
Constance Guille

List of Studies


Keywords
Obstetrics and Gynecology, Post Partum Depression, Psychiatry
Summary

The main purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in adults with severe postpartum depression (PPD). SAGE-217 is is an investigational drug, which means that it is not yet approved to treat PPD. Participation in the study will last up to 76 days and includes a 14 day treatment period where SAGE-217 is taken by oral pill daily. Visits will take approximately 1 to 3 hours.

Institution
MUSC
Recruitment Contact
Natalie Naylon
843-792-5824
naylon@musc.edu

Umbilical Cord-derived Mesenchymal Stem Cells (MSC) for Cellular Therapy

Date Added
June 16th, 2020
PRO Number
Pro00099509
Researcher
Hongjun Wang

List of Studies


Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to obtain viable mesenchymal stem cells (MSCs) from umbilical cords in uncomplicated planned cesarean deliveries. Potential donors will be screened prior to donation of umbilical cords to confirm no infectious disease, viruses and/or diseases. The overall goal is to obtain MSCs from healthy donors for eventual transfusion into patients for potential treatment of diseases, such as chronic pancreatitis, systemic sclerosis, type 1 diabetes, COVID 19, acute respiratory distress syndrome (ARDS), and other diseases in studies approved by the IRB. We also want to store the cells as repository for other potential therapy.

Institution
MUSC
Recruitment Contact
Meghan Blalock
843-792-1800
schneidm@musc.edu

Cepheid / "Clinical Evaluation of Xpert Xpress GBS Test"

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

List of Studies


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

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

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

List of Studies


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

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

List of Studies


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

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

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

List of Studies


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

Web-Based Treatment for Perinatal Opioid Use Disorder

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

List of Studies


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, as well as a text message based mental health and substance use screening and treatment program for pregnant and postpartum women, called Listening to Women (LTW). 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 of any race who misuse opioids or have opioid use disorder, obstetric providers who treat pregnant women with opioid misuse and opioid use disorder and women who self-identify as Black that has been pregnant or postpartum in the past 2 years and struggled with a substance use disorder or mental health disorder during this time OR did NOT struggle with a substance use disorder or mental health disorder during this time to participate in this study.

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

Date Added
October 3rd, 2018
PRO Number
Pro00078958
Researcher
David Gutman

List of Studies


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
Wanda Jones
843-792-1869
joneswr@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.

Date Added
December 19th, 2017
PRO Number
Pro00072393
Researcher
Katherine Herbert

List of Studies

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

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

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

List of Studies


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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