Northwestern University Feinberg School of Medicine

Department of Obstetrics and Gynecology

Clinical Trials

Clinical and Outcomes Research under the direction of the Department of Obstetrics and Gynecology is conducted at the Northwestern University Feinberg School of Medicine.

For more information about the research or participation, please call our office at 312-695-7542.

Trials
PACTG 1026s: Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum (Former NUIRBS# 0213-020/Garcia)
The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant w…
The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
Sutton, Sarah HSutton, Sarah H
NCT00042289 STU00030724
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1-855-NU-STUDY
NCI 01X1: Breast Cancer Program: Tissue and Specimen Collection Facility (Former NUIRBS #1617-002/Clevenger)
The purpose of this research study is to help advance the scientific understanding of breast cancer. A portion of breast or skin tissue and a sample of blood, along with clinical…

The purpose of this research study is to help advance the scientific understanding of breast cancer. A portion of breast or skin tissue and a sample of blood, along with clinical information, will be collected and stored in a database for research purposes only. 

Only tissue or fluid in excess of that required for clinical diagnosis and/or staging will be collected. Specific clinical data will include: treatment for cancer (surgical procedures, chemo or hormone therapy, radiation), cancer outcome (recurrence, metastases, death due to disease, and death without disease, alive, alive with disease). 

You may be eligible for this research study if you are a woman with breast cancer undergoing biopsy or surgical procedures for the diagnosis, treatment, or prevention of your cancer. 
Wei, Jian-JunWei, Jian-Jun
  • Map it 201 E. Huron St.
    Chicago, IL
STU00023488
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Study Coordinator 1 312 695 1102
NuMoM2B
Forty percent of pregnant women in the United States are women who have never given birth. As a group, they sometimes have complications with their pregnancy, but there is no information from a previous pregnancy to identify who might have a problem. Very little research has been done with th…
Forty percent of pregnant women in the United States are women who have never given birth. As a group, they sometimes have complications with their pregnancy, but there is no information from a previous pregnancy to identify who might have a problem. Very little research has been done with this group. The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) is collecting data from a diverse population of about 10,000 women who are having their first baby and are carrying only one baby. The women are enrolled early in pregnancy and undergo research assessments four times during their pregnancies. Data are collected through interviews, self-completed data forms, clinical measurements, ultrasound, and collection and storage of blood samples, urine samples, and fluid from the vagina and cervix. Some information comes from medical records. A subset of women may be asked to participate in substudies collecting information on sleep breathing, sleep patterns and quality, or other areas possibly related to birth outcomes. The goal of the research is to find ways to identify women in this group who might develop a problem with their pregnancy and use this information to improve the health of pregnant women and their babies in the future. The study is focusing on pregnancy problems like high blood pressure, babies that are born much too early and very small babies.
Recruitment closed.
Grobman, William AGrobman, William A
  • Map it 633 N. St. Clair St
    Chicago, IL
NCT01322529 STU00030993
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Rangel, Elizabeth
B-WELL-Mom
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience worsening of their symptoms while others improve. Because pre…
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience worsening of their symptoms while others improve. Because pregnancy affects lung function and immune response of all women, we are looking for both women with and without asthma to participate. The study consists of 4 clinic visits (1st, 2nd, and 3rd trimesters of pregnancy and 4 months postpartum), and an at-home diary.
-Pregnant women at least 18 years old.
-Less than 15 weeks pregnant with a single baby.
-Women with and without asthma are eligible to participate. -No diagnosis of Multiple Sclerosis, Lupus, Rheumatoid Arthritis, HIV, or Mixed Connective Tissue Disease.
Grobman, William AGrobman, William A
STU00093038
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Wolfe, Kaitlin A
nuMoM2b Heart Health Study
This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 7 years postpartum. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnan…
This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 7 years postpartum. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnancy in the nuMOM2b Study.
By invitation only. Women who previously participated in the nuMOM2b Study and who are 18+ years old are invited to participate in the nuMOM2b Heart Health Study. These women also consented to be contacted for future research studies and did not previously withdraw from the nuMoM2b cohort.
Grobman, William AGrobman, William A
  • Map it 633 N. St. Clair St
    Chicago, IL
NCT02231398 STU00098233
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Rangel, Elizabeth
Mag study
Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of pregnancy. The primary aim of this study is to determine if women who receive magnesium are less likely to experience postpartum depression. Other aims include examining…
Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of pregnancy. The primary aim of this study is to determine if women who receive magnesium are less likely to experience postpartum depression. Other aims include examining the relationship between receiving magnesium and cognitive function and birth experience.
Miller, EmilyMiller, Emily
NCT02454322 STU00200388
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1-855-NU-STUDY
The SLIM Study
The aim of this trial is to determine whether midurethral sling (MUS), combined with injections of a prescription medicine used to treat urinary leakage is more effective than MUS alone in improving urinary incontinence symptoms. The primary outcome of this study is to see if a miduret…
The aim of this trial is to determine whether midurethral sling (MUS), combined with injections of a prescription medicine used to treat urinary leakage is more effective than MUS alone in improving urinary incontinence symptoms. The primary outcome of this study is to see if a midurethral sling combined with injections will help mixed urinary incontinence. This study is for women who plan on going midurethral sling surgery for their mixed incontinence.
The study will include women undergoing mid-urethral sling surgery and have symptoms of both stress and urgency urinary incontinence. Participants that have a history of recurrent UTI's, undergoing concomitant prolapse surgery, and who have had previous bladder injections will not be considered eligible for the study.







Kenton, KimberlyKenton, Kimberly
  • Map it 250 E. Superior St.
    Chicago, IL
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
NCT02678377 STU00201249
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Tavathia, Meera
OPTI-MOM
The purpose of this study is to explore the way the antidepressant concentration (amount of medication) in the blood changes due to the physiological changes in the body (i.e., increased metabolism, hormones, and body fluid) during pregnancy and postpartum. Taking the same medication dose …
The purpose of this study is to explore the way the antidepressant concentration (amount of medication) in the blood changes due to the physiological changes in the body (i.e., increased metabolism, hormones, and body fluid) during pregnancy and postpartum. Taking the same medication dose when you are pregnant may result in an amount of drug in your blood that is different than when you are not pregnant. We will also study the impact of genetic factors on the amount of drug in your blood. Drug metabolism (how medications are broken down, absorbed, and removed from the body) differs among people because of their unique genetic make-up, which can cause medications to be metabolized faster or slower. This means that when two people with different genetic backgrounds take the same dose, the concentration of the medicine in their blood can vary dramatically. . Changes in antidepressant concentrations are important to monitor, as decreases in drug levels may cause the antidepressant to become ineffective and result in an increase in mood symptoms or recurrence of depressive episodes. Increases in antidepressant concentration may lead to increased side effects. We are hoping to better understand the course of these changes across pregnancy and postpartum and how an individual’s genetic makeup impacts these changes. Our overall goal is to develop guidelines to optimize antidepressant treatment of pregnant women
Are 18 years of age or older
Are currently at or less than 18 weeks pregnant
Speak English or Spanish
Have received a diagnosis of depression
Take sertraline (Zoloft), fluoxetine (Prozac), citalopram (Celexa), or escitalopram (Lexapro) and plan to continue it during pregnancy and postpartum
Wisner, KatherineWisner, Katherine
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT02519790 STU00201386
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O'Shea, Kelly
VESPR
The aim of this study is to compare and assess women who sustain a severe tear during their first pregnancy. They will be randomized to either vaginal electrical stimulation 1 week postpartum or to no stimulation. The primary outcome of this study will be to assess and compare complications ass…
The aim of this study is to compare and assess women who sustain a severe tear during their first pregnancy. They will be randomized to either vaginal electrical stimulation 1 week postpartum or to no stimulation. The primary outcome of this study will be to assess and compare complications associated with this tear via questionnaires and an ultrasound. This study is for women who sustained a tear during their first pregnancy.
The study will include women who sustained a severe tear during their first pregnancy will be considered eligible for the study. Participants that have wound breakdown or infection, and have an implanted electrical device will not be considered eligible for the study.
Gaupp, Christina LewickyGaupp, Christina Lewicky
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
NCT02701413 STU00201026
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Tavathia, Meera
E4 Freedom Contraceptive Trial
The E4 Freedom study is investigating a new Combined Oral Contraceptive pill. In the study, we hope to find out how safe and effectiev this pill is at preventing pregnancy, and what periods are like during the menstrual cycle while taking the pill. We will also monitor …
The E4 Freedom study is investigating a new Combined Oral Contraceptive pill. In the study, we hope to find out how safe and effectiev this pill is at preventing pregnancy, and what periods are like during the menstrual cycle while taking the pill. We will also monitor your well-being throughout the study. The study will last about one year. During the study, participants that meet the study requirements will be asked to take the study pill once a day and to come to the study site at least 7 times for visits.
Age 18-50, heterosexually active females requiring contraception to prevent pregnancy, in good physical and mental health. If over age 35, must be a non-smoker.
Shulman, Lee PShulman, Lee P
NCT02817841 STU00203509
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Romero, Denise S
LIBERTY 2: Efficacy and safety of Relugolix with and without estradiol/norethindrone acetate in uterine fibroids
Our goal is to evaluate the effectiveness and safety of investigational medicines for heavy bleeding associated with uterine fibroids. The study drugs will be compared to an inactive subs…
Our goal is to evaluate the effectiveness and safety of investigational medicines for heavy bleeding associated with uterine fibroids. The study drugs will be compared to an inactive substance (called a placebo) to see if the new study drugs are working. There is an entry period for up to 13 weeks (up to 4 study visits) to determine eligibility, which includes: transvaginal ultrasound, endometrial biopsy, menstrual blood collection, bone density scan and a mammogram. There will be a randomization visit followed by 6 monthly treatment visits. The treatment period will take place over 24 weeks. During treatment, participants will take two study drugs or placebo by mouth throughout the treatment period. After the end of treatment, participants will be followed for 30 days to assess effectiveness and safety after stopping treatment. In total, participants will be in the research study for up to 10 months. All research related medications, supplies, procedures and lab work are at no cost to participants. Participants will be compensated for time and travel related to this study.
Inclusion criteria: 1) Women aged 18-50 years; 2) Heavy menstrual bleeding associated with uterine fibroids, as diagnosed by a physician; 3) English-speaking
Robins, JaredRobins, Jared
  • Map it 259 E. Erie St. Lavin Pavilion
    Chicago, IL
NCT03103087 STU00205214
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Posley, Dana
Therapy for Women with Urinary Symptoms
This study aims to examine the efficacy of cognitive behavioral therapy (CBT) compared to supportive therapy for women with urinary symptoms and anxiety.
You may be eligible for this study if you are a woman the age of 18 or older, with one or more of the following urinary symptoms in the past 12 months and current seeking treatment: frequency, nocturia, urgency, leakage, hesitancy, straining, or dribbling, AND anxiety or emotional distress. You will be asked to complete a 12-week therapy intervention, as well as five surveys over the course of the study, and will be compensated for your time. 
Griffith, James WGriffith, James W
STU00207124
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Borowska, Sylwia
FOCUS
This randomized clinical drug trial is comparing two different strategies or oral antibiotics as treatment for complicated urinary tract infections (cUTI). Participants will be randomized to one of two initial study drugs. Participants will be in this study for approximately 28 days. Participan…
This randomized clinical drug trial is comparing two different strategies or oral antibiotics as treatment for complicated urinary tract infections (cUTI). Participants will be randomized to one of two initial study drugs. Participants will be in this study for approximately 28 days. Participants will be required to provide a urine sample, a blood specimen, and asked to return for two more in-person visits after receiving the study drug. Participants will be responsible for filling out a Memory Aid at home where they will record their temperature, symptoms, and the time that they took their antibiotic. 
You may be eligible for this study if:

  • You are 18 years or older and have a complicated urinary tract infection (cUTI) or a kidney infection called pyelonephritis
  • Your physician decides you are able to be given oral antibiotics initially or as a step-down therapy

Kenton, KimberlyKenton, Kimberly
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
NCT03697993 STU00207104
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Borowska, Sylwia
Leva Plus vs. Kegel Exercises in the Treatment of SUI
This study will compare how a new device - the leva Pelvic Digital Health System - helps women with urinary leakage compared to pelvic exercises alone. The leva is an intravaginal device designed to view pelvic floor movement that is insert…

This study will compare how a new device - the leva Pelvic Digital Health System - helps women with urinary leakage compared to pelvic exercises alone. The leva is an intravaginal device designed to view pelvic floor movement that is inserted and worn like a tampon. If you qualify, you will either use the leva for ~8 weeks and perform pelvic exercises for 2 1/2 minutes twice a day, or perform the exercises alone 3 times a day without using the leva device. 

We are looking for women age 18 or older with urinary incontinence to participate in a research study. 

You may be eligible for this study if:

  • You leak urine with coughing, sneezing, laughing, physical activity, or heavy lifting 
  • You have experienced stress urinary incontinence (SUI) for at least 3 months
  • You are willing to refrain from other treatment for SUI during the first 8 weeks (including wearing a pessary, surgery, or participating in pelvic floor physical activity)

You are not eligible for this study if:

  • You have stage 3-4 pelvic organ prolapse
  • You have had pelvic floor physical therapy within the last 12 months
  • You are currently pregnant or <12 months postpartum or planning on getting pregnant in the next 12 months,
  • You have a neuromuscular disease

Collins, SarahCollins, Sarah
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
NCT03632447 STU00207477
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Borowska, Sylwia
MICRO Study
We are conducting this research study because we are seeking a better treatment regimen for patients that have pelvic organ prolapse (POP). Surgical correction of POP can result in development of stress urinary incontinence (SUI) - leakage of urine associated with cough, laugh or sneeze e…
We are conducting this research study because we are seeking a better treatment regimen for patients that have pelvic organ prolapse (POP). Surgical correction of POP can result in development of stress urinary incontinence (SUI) - leakage of urine associated with cough, laugh or sneeze even in patients who have never had these symptoms before. We therefore want to investigate if addition of minimally invasive Burch colposuspension at the time of sacrocolpopexy will help prevent SUI after surgery in women who do not have pre-existing symptoms of SUI. If our hypothesis that minimally invasive Burch colposuspension at the time of minimally invasive sacrocolpopexy will lower rates of SUI after surgery is correct, this could greatly improve upon our current surgical treatment of women with POP. 

You may be eligible for this study if you are a woman over the age of 18 who is planning to have a laparoscopic or robotic sacrocolpopexy, with or without hysterectomy. Participants may be English or Spanish speaking and reading. This study is for women who are stress continent, who do not leak urine with coughing, sneezing, or laughing. To participate in this study you must have completed childbearing. 

Exclusion Criteria:

  • Pregnant women or patients desiring future pregnancy
  • Patients undergoing uterine sparing surgery
  • Individuals under age 18
  • Prior procedure for stress urinary incontinence
  • Prior retropubic surgery

Collins, SarahCollins, Sarah
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
NCT03841513 STU00208016
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Borowska, Sylwia
Altis RCT
This study is for women who have stress urinary incontinence when their vaginal bulge is returned to its normal position and who have opted for surgical management with a sling that will help support the urethra or the tube that carries urine from the bladder to the outside of the body. The…
This study is for women who have stress urinary incontinence when their vaginal bulge is returned to its normal position and who have opted for surgical management with a sling that will help support the urethra or the tube that carries urine from the bladder to the outside of the body. The purpose of this study is to compare two different types of FDA approved slings used for surgery. Participants will be asked to complete study questionnaires and attend 6 regular care visits. 
You may be eligible for this study if:

  • You are at least 21 years of age
  • You are a woman being considered for a native vaginal repair in any vaginal compartment or colpocleisis
  • You have pelvic organ prolapse stage 2-4 and have vaginal bulge symptoms

Kenton, KimberlyKenton, Kimberly
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
STU00208116
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Borowska, Sylwia
NESCA

This is a pilot study to assess the effectiveness of a device in collecting information about the motion of the female pelvic floor. Four groups of women will wear the device for 3 days while completing their regular daily routines.

You may be eligible for this study if:

  • you are sedentary or physically active

  • you have stress urinary incontinence (leakage with coughing, sneezing, laughing, movement) or no incontinence.

Collins, SarahCollins, Sarah
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
STU00209037
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Borowska, Sylwia