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

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

List of Studies

Silhouette
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

List of Studies

Silhouette
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

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

List of Studies

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

List of Studies


Profiles_link
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

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