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
Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
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 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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1-888-NU-STUDY
Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be
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 hav…
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 1 312 503 6287
B-WELL-Mom (Breathe-Wellbeing, Environment, Lifestyle, and Lung Function)
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…
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 312 503 3248
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 312 503 6287
The Effect of Magnesium on Maternal Mood, Cognitive Function, and Birth Experience
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 …
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
Permanent versus delayed-absorbable monofilament suture for vaginal graft attachment during minimally-invasive total hysterectomy and sacrocolpopexy: A Randomized Clinical Trial
The aim of this study is to compare permanent stitches to delayed absorbable stitches for attachment of vaginal mesh (net-l…
The aim of this study is to compare permanent stitches to delayed absorbable stitches for attachment of vaginal mesh (net-like implant) in total removal of the uterus and repairing of the pelvic organs. The primary outcome for this study is comparing vaginal mesh and stitches exposure rates.This study is for women who are planning on undergoing surgical treatment for pelvic organ prolapse.
The study will include women with anterior or posterior vaginal prolapse, who have completed childbearing, are seeking surgical management, and are willing to proceed with placement of abdominal mesh. Participants who have had a prior hysterectomy and are not surgical candidates will not be considered eligible for the study.
Kenton, KimberlyKenton, Kimberly
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
NCT02277925 STU00200281
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Tavathia, Meera 312 926 7846
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
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 sympto…
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 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
  • Map it 250 E. Superior St.
    Chicago, IL
NCT02678377 STU00201249
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Tavathia, Meera 312 926 7748
Optimizing Medication Management for Mothers with Depression (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) dur…
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 312 695 6076
Development of a non-invasive prenatal screening test for multiple gestation pregnancies based on fetal DNA isolated from maternal blood
The purpose of this study is to collect blood samples from women with a multiple pregnancy (e.g. twins) to develop a prenatal diagnosic blood test that would evalu…
The purpose of this study is to collect blood samples from women with a multiple pregnancy (e.g. twins) to develop a prenatal diagnosic blood test that would evaluate the health of the fetuses in a non-invasive way. In this study, Natera’s non-invasive prenatal Laboratory Developed Test (LDT) will be tested for its ability to detect a wider range of fetal abnormalities specifically in the case of multiple pregnancies. Because this test is considered to be experimental, and is not yet FDA approved, not genetic analysis results will be shared with participants.
Inclusion criteria: 1) Age 18 or older at enrollment; 2) Clinically confirmed multiple gestation pregnancy; 3) Gestational age between 9 weeks, 0 days and 26 weeks 0 days; 4) English speaking and able to provide informed consent. Exclusion Criteria: 1) Women carrying singleton pregnancy; 2) Surrogate or egg donor used; 3) Women who underwent pre-implantation genetic screening (PGS/PGD) at the time of in vitro fertilization (IVF)
Robins, JaredRobins, Jared
  • Map it 259 E. Erie St. Lavin Pavilion
    Chicago, IL
STU00202432
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Posley, Dana 312 503 8624
The association between the urinary microbiome and response to sacral neuromodulation in women with urgency urinary incontinence
This study aims to identify urinary bacteria which may predict a successful response to nerve stimulation. The primary outcome of this study is to see if patients with cert…
This study aims to identify urinary bacteria which may predict a successful response to nerve stimulation. The primary outcome of this study is to see if patients with certain urinary bacteria respond better to nerve stimulation and if the nerve stimulation changes the normal urinary bacteria. This study is for women who are planning to undergo nerve stimulation for overactive bladder.
The study will include women over the age of 18 with UUI planning to undergo SNM implantation will be included if they have at least 2 UUI episodes on a baseline 3-day bladder diary. Participants that have neurologic disease or have recurrent UTI will not be considered eligible for the study.


Mueller, MargaretMueller, Margaret
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
NCT02833402 STU00202669
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Tavathia, Meera 312 926 7846
A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15 mg Estetrol and 3 mg Drospirenone
The E4 Freedom study is investigating a new Combined Oral Contraceptive pill. In the study, we hope to find out how safe and e…
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 312 503 1804
Postpartum GRANulation Tissue: The GRANT Study
The aim of this study is to evaluate women who develop scar tissue following an obstetric tear. The properties of the tissue will be studied to determine the role of estrogen. The objective is to find a non-surgical treatment option for women who develop…
The aim of this study is to evaluate women who develop scar tissue following an obstetric tear. The properties of the tissue will be studied to determine the role of estrogen. The objective is to find a non-surgical treatment option for women who develop granulation tissue after childbirth. This study is for women who had an obstetric tear and developed scar tissue during postpartum recovery.
The study will include women who have sustained an obstetric laceration that develop perineal and/or vaginal granulation tissue during postpartum recovery. Participants who are pregnant, unable to consent 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
  • Map it 250 E. Superior St.
    Chicago, IL
STU00203501
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Tavathia, Meera 312 926 7846
LURN: Qualitative Assessment of Lower Urinary Tract Dysfunction Study Protocol 2: Recall Study
This large, multicenter study aims to comprehensively characterize the self-reported experiences of patients with lower urinary symptoms for the purpose of enhancing efforts to explain important subtypes of…
This large, multicenter study aims to comprehensively characterize the self-reported experiences of patients with lower urinary symptoms for the purpose of enhancing efforts to explain important subtypes of patients with these symptoms. Participants will complete a baseline assessment along with daily, weekly, and monthly assessments according to the group they are randomized to.
18 years of age or older; willing and able to give informed consent; able to speak, read, and understand English; ability to complete self-reported questionnaires electronically; experienced at least moderate severity and bother from at least 1 of 7 targeted symptoms in the past 2 weeks and in the past 3 months
Cella, DavidCella, David
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
STU00204923
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Tavathia, Meera 312 926 7846
LIBERTY 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids
Our goal is to evaluat…
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 312 472 0289