MWRI Trials at UPMC Hamot
Steve N. Caritis Magee Obstetric Maternal & Infant (MOMI) Database and Biobank
Biospecimens are collected for banking and future use in research. The biobank stores biological specimen and health information (through medical records review) that are then used for future research. Specimens are not associated with participants’ names. Specimens collected:
- 1st, 2nd, 3rd Trimesters: Maternal blood and urine
- L&D: Maternal blood, maternal urine, placenta, cord, cord blood
- After delivery: Infant meconium (has not yet started)
DP3: Deep Phenotyping of Pregnancy Project
Observational study of pregnant women 18 and older enrolled in their first trimester. The purpose of this study is to construct a blueprint of a healthy pregnancy. Participants complete questionnaires, wear a Fitbit, use an air monitor in the home, collect microbiome sample and provide specimen samples at appointments/delivery. (blood, urine, hair samples, placenta, and meconium)
Follow this link for more information on the Deep Phenotyping of Pregnancy Project.
HH4NM (Heart Health 4 New Moms)
An internet-based intervention to provide women with tools aimed to improve weight and blood pressure management in the year following delivery among women with prior preeclampsia or gestational hypertension. Participants will be randomized into one of three groups:
- Usual care group: Receive educational materials regarding risk of heart disease in women with gestational hypertension or preeclampsia in a prior pregnancy.
- Home blood pressure monitoring group: Educational materials and home blood pressure monitoring.
- Internet-based lifestyle intervention group: Educational materials and access to an internet-based Heart Health 4 New Moms website. Participants are connected to a lifestyle coach and complete home blood pressure monitoring.
Follow this link for more information on HH4NM (Heart Health 4 New Moms).
Mesh Biorepository Study: Insight into the Pathogenesis of Mesh Complications
A biorepository and database of mesh-related complications aiming to better understand symptoms of mesh complications, and to identify which women are at greatest risk of experiencing complications. Investigators are also attempting to determine the way tissues react to mesh placement and how the specific properties of each type of mesh impacts complication rates. Understanding the mechanisms that cause mesh complications will ideally allow these adverse outcomes to be prevented in the future. Specimens/information collected:
- Mesh and associated vaginal tissue that is removed as part of your procedure that would otherwise be discarded.
- A vaginal biopsy sample, blood, urine, and swab samples.
- Questionnaires and a detailed medical history.
MERIT: Impact of level III support procedures on normalization of enlarged genital hiatus after minimally invasive Sacro colpopexy
Patients undergoing MISC for POP with a preoperative genital hiatus between 4.0 and 7.5cm will be recruited for this study. Patients enrolled with preoperative genital hiatus greater than or equal to 4cm will have a repeat genital hiatus measured intraoperatively, post-sacrocolpopexy, and if still greater than 4cm will be randomized to concomitant perineorrhaphy or not. Data will be analyzed from baseline, intraoperative, and 3-6 months, 12 months, and 24 months postoperative POP-Q examinations as well as patient questionnaires from baseline, 3-6 months and 24 months postoperative visits.
Developing and Testing an Evidence-Based Toolkit for Nursing Home Care of Residents with Obesity
This study has two parts:
- Evaluate nursing homes’ use of specific organizational strategies that make it easier or more difficult to provide safe care for residents with obesity
- Evaluate a toolkit to help decision makers and caretakers implement effective safety strategies to provide better care for nursing home residents with obesity.
SCOOP3: Longitudinal nature of postoperative cognitive dysfunction in older women undergoing pelvic organ prolapse surgery
Women greater than or equal to 70 years old undergoing pelvic organ prolapse surgery assessed for postoperative cognitive dysfunction using neuropsychological and task based cognitive assessments at 2 weeks, 3 months, and 12 months postoperatively.
MIRACLE of LIFE Study: Observational Study of Pregnant Women to Validate Biomarkers of Pregnancy Complications Risk
Pregnant women, 18-45 years old with a single pregnancy less than 22 weeks gestation will be asked to have a blood draw and complete a short survey at a one-time study visit, which can align with a regular prenatal appointment or be scheduled at their convenience. The study aim is to validate a blood test designed to predict pregnancy complications.
Women’s Microbiome Study
Postmenopausal women age 55-64 with no prior history of cancer and not on hormone replacement therapy with a normal mammogram at a UPMC facility within the past six months are eligible. This study seeks to identify biomarkers of health and diseases present in biologic specimens, especially the gut microbiome. The relationship of these markers to demographic, reproductive, clinical and pathologic data will be examined. The relationship of markers to survival will also be examined. The goal is to identify potential markers or precursors of cancer and other women's health conditions as well as factors that may affect them so that researchers can potentially identify prevention and treatment targets.
MUSA (Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A)
Mixed urinary incontinence (MUI), defined as the presence of both stress urinary incontinence (SUI) and urgency urinary incontinence (UUI), is a challenging condition for which clinicians frequently use multiple sequential treatments that have undergone limited evaluation in rigorous clinical trials. The Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA) trial will estimate the effect of intradetrusor injections of Botulinum toxin A (Botox A ®) compared to mid-urethral sling for the treatment of MUI symptoms in 146 women. MUSA is a randomized 2-arm clinical trial.
The purpose of MUSA is to:
- Compare treatment with either intradetrusor injections of Botulinum toxin A (Botox A ®) or mid-urethral sling for women with MUI
- Characterize patient characteristics associated with treatment response
The primary objective is to estimate the effect of intradetrusor injections Botulinum toxin A (Botox A ®) compared to mid-urethral sling for treatment of MUI in 146 women 6 months after treatment. The change in severity of MUI symptoms will be measured using the Urogenital Distress Inventory.
For more information, watch the MUSA Recruitment Video on YouTube. It is available in both English and Spanish.
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