An Observational Study of Hepatitis C Virus in Pregnancy
Aims: The purpose of this observational study is to understand the risk factors associated with mother to child transmission of HCV. Pregnant women who screen positive for HCV will be matched to controls without the virus.
Diagnosis: Pregnant and screen-positive for Hepatits C virus, or matched control without the virus
Principal Investigator: Mara Dinsmoor, MD, MPH
Co-Investigator(s): Ann Borders, MD, MPH; Loraine Endres, MD; Ian Grable, MD, MPH; Amanda Horton, MD; Scott Macgregor, DO; Mark Neerhof, DO; David Ouyang, MD; Beth Plunkett, MD; Richard Silver, MD
IRB Approval Number: EH13-131
Sponsor: NIH
Contact: Interested patients should contact Kristin Paychek at 847.570.4253
Open to Enrollment: No

Pilot Study of Social Conditions in Pregnancy and Fetal Development
Aims: The purpose of this study is to explore how the social, economic, and lifestyle conditions affect the early stages of fetal development.
Diagnosis: Singleton pregnancy less than 24 weeks, planning to have an amniocentesis. Principal Investigator: Ann Borders, MD
Co-Investigator(s):  Greg Miller, PhD
IRB Approval Number: EH13-256
Sponsor: NIH/Northwestern University
Contact: Sameen Qadir at 847.570.1971
Open to Enrollment: Yes

A Randomized Clinical Trial of Antioxidants to Prevent Preeclampsia (CAPPS)
Aims: The purpose of this research study is to determine if high doses of vitamins C and E will reduce the risk of preeclampsia and other problems during pregnancy associated with this disease. Preeclampsia is characterized by high blood pressure and proteinuria (protein in urine) in the second half of pregnancy.
Diagnosis: Pregnant for the first time, and less than 16 weeks gestational age.
Principal Investigator: Mara Dinsmoo,r MD, MPH
IRB Approval Number: EH04-023
Sponsor: NIH
Contact: Interested patients should contact Kristin Paychek at 847.570.4253
Open to Enrollment: No

A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk (Omega-3)
Aims: The purpose of this study is to see whether taking capsules containing Omega-3 fatty acid supplementation in addition to  progesterone injections further decreases the chance of preterm birth, for women who are pregnant and had a preterm birth in a prior pregnancy.  Omega-3 fatty acids are nutritional supplements, similar to vitamins, that are obtained from fish oil.
Diagnosis: Pregnant, with a preterm delivery in a previous pregnancy.
Principal Investigator: Mara Dinsmoor, MD, MPH
IRB Approval Number: EH05-150
Sponsor: NIH
Contact: Interested patients should contact Kristin Paychek at 847.570.4253
Open to Enrollment: No

A Randomized Trial of Thyroxine Therapy for Subclinical Hypothyroidism or Hypothyroxinemia Diagnosed During Pregnancy
Aims: The goal of this study is to evaluate the potential risks and/or benefits of treating asymptomatic low thyroid hormone levels during pregnancy.Thyroid hormones during pregnancy are important for the development of a baby's brain. Typically, women with symptomatic low levels are treated, but benefit of treatment for mild disease is unknown. Women who agree to participate will be randomized to receive either  thyroid hormone supplementation or placebo. Testing of the child will be done on a yearly basis for five years to evaluate intellectual development.
Diagnosis: Less than 22 weeks pregnant, with hypothyroidism or hypothyroxenemia
Principal Investigator: Mara Dinsmoor MD MPH
Co-Investigator(s): Ann Borders, MD, MPH; Loraine Endres, MD; Ian Grable, MD, MPH; Amanda Horton, MD; Scott Macgregor, DO; Mark Neerhof, DO; David Ouyang, MD; Beth Plunkett, MD; Richard Silver, MD
IRB Approval Number: EH07-083
Sponsor: NIH
Contact: Interested patients should contact Kristin Paychek at 847.570.4253
Open to Enrollment: No

A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women with a Short Cervix
Aims: The goal of this study is to determine if first-time pregnant mothers with a short cervix on ultrasound will benefit from having weekly progesterone shots. Progesterone shots have been shown to decrease the rate of recurrent preterm birth in women who have had a prior preterm birth. This study is to evaluate this treatment in another group of women at high risk for preterm birth.
Diagnosis: Pregnant for the first time, found to have a short cervix on ultrasound
Principal Investigator: Mara Dinsmoor, MD, MPH
IRB Approval Number: EH07-250
Sponsor: NIH
Contact: Interested patients should contact Kristin Paychek at 847.570.4253
Open to Enrollment: No

An Observational Cohort Study to Evaluate Measures of Quality of Obstetric Care
Aims: This research study collected data on women delivering babies at Evanston Hospital.  Data related to maternal and neonatal outcomes and complications during pregnancy, labor, and delivery were abstracted from the patients’ medical records, and analyzed to evaluate proposed safety  and quality measures.
Diagnosis: delivering at Evanston Hospital
Principal Investigator: Mara Dinsmoor, MD, MPH
IRB Approval Number: EH07-447
Sponsor: NIH
Contact: Interested patients should contact Kristin Paychek at 847.570.4253
Open to Enrollment: No

A Registry Study of Novel Swine-Origin H1N1 Influenza a Virus Among Hospitalized Pregnant Women
Aims: The purpose of this study was a review of medical records to determine whether hospitalized pregnant women with influenza-like illness experienced higher mortality than the influenza-related mortality expected in the hospitalized general population during the recent influenza pandemic caused by novel swine-origin H1N1 influenza A virus.
Diagnosis: Pregnant, and hospitalized at NorthShore University HealthSystem with influenza-like illnesss
Principal Investigator: Mara Dinsmoor, MD, MPH
IRB Approval Number: EH09-532
Sponsor: NIH
Contact: Interested patients should contact Kristin Paychek at 847.570.4253
Open to Enrollment: No

Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Aims: This study will determine if Betamethasone should be administered to the late preterm mom (34-36/5weeks GA) at risk of delivering early. Betamethasone is a steroid drug that is already given to women anticipated to deliver prior to 34 weeks, to improve lung development in the fetus, but it is unknown if there is also benefit in the 34-36 week range.
Diagnosis: Singleton pregnancy with anticipated delivery between 34-36 weeks.
Principal Investigator: Mara Dinsmoor MD MPH
Co-Investigator(s): Ann Borders, MD, MPH; Loraine Endres, MD; Ian Grable, MD, MPH; Amanda Horton, MD; Scott Macgregor, DO; Mark Neerhof, DO; David Ouyang, MD; Beth Plunkett, MD; Richard Silver, MD
IRB Approval Number: EH10-166
Sponsor: NIH
Contact: Interested patients should contact Kristin Paychek at 847.570.4253
Open to Enrollment: No, temporarily closed

Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus
Aims: The purpose of this research study is to see if dietary treatment and monitoring reduce the incidence of neonatal morbidity and mortality in women diagnosed with mild gestational diabetes, as compared with those receiving standard obstetrical care
Diagnosis: Women with gestational diabetes, elevated glucose, or matched controls
Principal Investigator: Mara Dinsmoor, MD, MPH
IRB Approval Number: EH10-187
Sponsor: NIH
Contact: Interested patients should contact Kristin Paychek at 847.570.4253
Open to Enrollment: No

A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN)
Aims: The goal of this study is to see how physicians and midwives utilize a new fetal monitor during labor to interpret electronic fetal heart rate patterns. Researchers are interested to learn if there is any reduction in the rate of fetal compromise (fetal acidosis) at birth and need for cesarean section. 
Diagnosis: In labor with gestational age greater than 36 weeks.
Principal Investigator: Mara Dinsmoor, MD, MPH
Co-Investigator(s): Ann Borders, MD, MPH; Loraine Endres, MD; Ian Grable, MD, MPH; Amanda Horton, MD; Scott Macgregor, DO; Mark Neerhof, DO; David Ouyang, MD; Beth Plunkett, MD; Richard Silver, MD
IRB Approval Number: EH10-257
Sponsor: NIH
Contact: Interested patients should contact Kristin Paychek at 847.570.4253
Open to Enrollment: Yes

Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy, Protocol TT-001
Aims: The purpose of this research is to find out whether analyzing DNA in a mother’s blood can be used to identify pregnancies with normal chromosomes and pregnancies with chromosome abnormalities such as Down syndrome.  This study will provide information that may eventually help determine if invasive procedures such as chorionic villus sampling and amniocentesis can be replaced by a non-invasive approach.  This study will test whether or not the experimental test comes up with the same results as the invasive procedures.
Diagnosis: Pregnant women undergoing amniocentisis or Chorionic Villus Sampling (CVS)
Principal Investigator: Mara Dinsmoor, MD, MPH
IRB Approval Number: EH11-083
Sponsor: Tandem Diagnostics Inc.
Contact: Interested patients should contact Marci Adams at 847.570.1283
Open to Enrollment: No

Translating Research Into Practice in Obstetrics (TRIO) (part of Maternal Fetal Medicine Units Network)
Aims: The purpose of this study is to understand how to translate clinical research efficiently into practice in the obstetrical setting. 
Diagnosis: Obstetricians practicing at NorthShore University HealthSystem
Principal Investigator: Mara Dinsmoor, MD, MPH
IRB Approval Number: EH11-204
Sponsor: NIH
Contact: Interested patients should contact Kristin Paychek at 847.570.4253
Open to Enrollment: No

A Randomized Trial to Prevent Congenital Cytomegalovirus Infection (CMV)
Aims: The purpose of this study is to determine if maternal administration of CMV hyperimmune globulin will lower the rate of congenital CMV infection among the children of women who have been diagnosed with primary CMV infection early in pregnancy. The study will screen consenting pregnant women before 23 weeks gestation. Those found to have primary CMV infection will be offered participation in the randomized study. 
Diagnosis: screening: singleton pregnancy, less than 23 weeks 
Randomized study: primary CMV infection
Principal Investigator: Mara Dinsmoor, MD, MPH
Co-Investigator(s): Ann Borders, MD, MPH; Loraine Endres, MD; Ian Grable, MD, MPH; Amanda Horton, MD; Scott Macgregor, DO; Mark Neerhof, DO; David Ouyang, MD; Beth Plunkett, MD; Richard Silver, MD
IRB Approval Number: EH12-070
Sponsor: NIH
Contact: Interested patients should contact Kristin Paychek at 847.570.4253
Open to Enrollment: Yes

Non-Invasive Chromosomal Examination of Trisomy Study (NEXT Study), Protocol TD007
Aims: The purpose of this research study is to evaluate an investigational blood test that detects fetal DNA (the genetic code of all living things) in a mother’s blood.  The investigational blood test will be compared with standard prenatal screening tests for detecting chromosome abnormalities in the fetus (like Down Syndrome). 
Diagnosis: Pregnant and having routine prenatal screening
Principal Investigator: Mara Dinsmoor, MD, MPH
Co-Investigator(s): Ann Borders, MD, MPH; Loraine Endres, MD; Ian Grable, MD, MPH; Amanda Horton, MD; Scott Macgregor, DO; Mark Neerhof, DO; David Ouyang, MD; Beth Plunkett, MD; Richard Silver, MD
IRB Approval Number: EH12-127
Sponsor: Ariosa Diagnostics
Contact: Interested patients should contact Marci Adams at 847.570.1283
Open to Enrollment: No

Immediate Post-Placental Insertion of the Levonorgestrel-Releasing Intrauterine System (LNG-IUS) After Cesarean Delivery vs. 4-8 Week Post-Delivery Interval Insertion: A Randomized Controlled Trial
Aims: The purpose of this study is to compare the use of a levonorgestrel-releasing intrauterine contraceptive system (Mirena® IUD) inserted immediately after delivery of the placenta during  cesarean delivery versus the use of the Mirena® IUD placed 4-8 weeks following cesarean section.  The researchers will evaluate differences in overall satisfaction with the method, expulsion (when the IUD comes out of the uterus on its own), menstrual periods and bleeding, other side effects and complications, pregnancy, and quality of life. 
Diagnosis: Having a cesarean delivery and planning to use Mirena IUD for contraception.
Principal Investigator: Loraine Endres, MD
IRB Approval Number: EH09-176
Sponsor: Society for Family Planning/The University of Chicago
Contact: Interested patients should contact Marci Adams at 847.570.1283
Open to Enrollment: No

Sonographic Examinations, Shoulder Dystocia, and Brachial Plexus Injury: A Case Control Study
Aims: This is a retrospective review of medical records to determine if a fetus with an abdominal circumference 5 cm larger than the head circumference on antenatal ultrasound is more likely to have a shoulder dystocia (when the baby's anterior shoulder is impacted under the maternal pubic bone at the time of delivery. )
Diagnosis: Medical records of pregnant women
Principal Investigator: Loraine Endres, MD
IRB Approval Number: EH12-163
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact Marci Adams at 847.570.1283
Open to Enrollment: No

Adverse Perinatal Outcomes in Dichorionic v. Trichorionic Triplets
Aims: This is a retrospective review of medical records to determine the factors associated with complications in triplet pregnancies
Diagnosis: Twin and triplet pregnancies delivered at NorthShore University HealthSystem hospitals between 1990-2010
Principal Investigator: Anna Gonzalez, MD
Co-Investigator(s): David Ouyang, MD; Scott Macgregor, DO; Richard Silver, MD
IRB Approval Number: EH11-185
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact Marci Adams at 847.570.1283
Open to Enrollment: No

In Term Pregnancy, Does Obesity Affect Rate of Failed Induction in Women Undergoing Cervical Ripening with Mechanical Balloon?
Aims: The purpose of this retrospective study of medical records is to evaluate the success of mechanical balloon cervical ripening for labor induction in obese patients compared to non-obese controls.
Diagnosis: Medical records of patients undergoing induction of labor at a NorthShore University HealthSystem hospital
Principal Investigator: Amanda Horton, MD
IRB Approval Number: EH12-333
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact Marci Adams at 847.570.1283
Open to Enrollment: No

Sleep-Disordered Breathing During Pregnancy: Relationship with Preeclampsia, A Cohort Study
Aims: The purpose of this study is to evaluate the relationship between sleep-disordered breathing during pregnancy and preeclampsia. Participants are given a take-home monitor to wear while they sleep on 2 nights, to identify women that may have sleep apnea.
Diagnosis: Pregnant, with diabetes, obesity, chronic hypertension, or preeclampsia in a previous pregnancy
Principal Investigator: David Ouyang, MD
IRB Approval Number: EH08-403
Sponsor: Preeclampsia Foundation/Northwestern University
Contact: Interested patients should contact Marci Adams at 847.570.1283
Open to Enrollment: No

Dietary and Behavioral Intervention to Reduce Weight Gain in Obese Pregnant Women
Aims: The purpose of this research is to evaluate the effectiveness of a program to help women limit their weight gain in pregnancy.  The program consists of a Motivational Interview with a trained dietician who will suggest ways to manage weight gain, and an on-line program to help manage diet and exercise.
Diagnosis: Pregnant, with Pre-pregnancy BMI > 30 kg/m2
Principal Investigator: Beth Plunkett, MD
Co-Investigator(s): David Victorson, PhD
IRB Approval Number: EH10-411
Sponsor: NorthShore University HealthSystem University HealthSystem Research Institute/Medical Group Pilot Grant Program
Contact: Interested patients should contact Marci Adams at 847.570.1283
Open to Enrollment: No

Fetal Cardiovascular Overgrowth and Maternal Diabetes<
Aims: The goal of this study is to help improve the health of babies born to women with diabetes. Fetuses of diabetic mothers will be compared to those of women without diabetes. From a blood sample, growth factors will be measured to try to discover the mechanism that may lead to enlarged hearts in the fetus.
Diagnosis: Pregnant women with diabetes, and matched controls
Principal Investigator: Beth Plunkett, MD
Co-Investigator(s): Luciana Young, MD
IRB Approval Number: EH11-241
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact Marci Adams at 847.570.1283
Open to Enrollment: No

Pilot Study for NU Bridge: Recruitment Feasibility and Study Palatibility (NU Bridge Study)
Aims: This is a pilot study to determine feasibility for a program that would look at how stress during pregnancy affects women's health and their baby's development. This pilot project consists of an anonymous questionaire completed in the waiting area of Evanston Hospital's outpatient clinic. The questionaire is designed to assess the number of potentially eligible patients and their demographic characteristics, as well as their comfort with and willingness to participate in research.
Diagnosis: Women receiving care at Evanston Hospital Outpatient Clinic
Principal Investigator: Beth Plunkett, MD
IRB Approval Number: EH12-254
Sponsor: Northwestern University
Contact: Interested patients should contact Marci Adams at 847.570.1283
Open to Enrollment: No

Incidence of Congenital Heart Block in Patients with Anti-SSA/Ro or Anti-SSB/La Antibodies Followed Closely with PR Interval Monitoring
Aims: The purpose of this retrospective study of medical records is to identify women with certain antibodies (SSA/Ro and SSB/La) and determine the incidence of fetal heart block
Diagnosis: Medical records of pregnant women with antibodies to SSA/Ro an dSSB/La
Principal Investigator: Ankit Shah, MD
Co-Investigator(s): David Ouyang, MD
IRB Approval Number: EH12-238
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact Marci Adams at 847.570.1283
Open to Enrollment: No

Population-Based Preconceptual Care: An Electronic Health Record Paradigm to Improve Pregnancy Outcomes
Aims: The purpose of this study is to plan the development of a program that would identify women who could benefit from education and care before becoming pregnant, even if they were not intending pregnancy. This project is a preliminary step, to evaluate the accuracy of information recorded in patients' medical records, by comparing it to a survey completed by the patient.
Diagnosis: Women who have received care at NorthShore University HealthSystem
Principal Investigator: Heather Straub, MD
Co-Investigator(s): Richard Silver, MD
IRB Approval Number: EH12-181
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact Marci Adams at 847.570.1283
Open to Enrollment: No

Pilot Study of Stress and Maternal-Fetal Health During Pregnancy
Aims:The purpose of this study is to explore how poverty influences the course and outcome of pregnancy.
Diagnosis: Singleton pregnancy less than 25 weeks
Principal Investigator:
Ann Borders, MD
Co-Investigator(s):
Greg Miller, PhD
IRB Approval Number:
EH13-402
Sponsor:
  NIH/Northwestern University
Contact:
  Sameen Qadir at 847.570.1971
Open to Enrollment:
  No

The role of membrane progesterone receptors in primary myometrial cells
Aims:
 The goal of this project is to understand how progesterone works, and to study the expression and functions of progesterone receptors in labor.
Diagnosis:
Women undergoing cesarean section
Principal Investigator:
Jing Lu, PhD
Co-Investigator(s):
Emmet Hirsch, MD
IRB Approval Number:
EH13-382
Sponsor:
none
Contact:
  Rita Elue at 847.570.1755
Open to Enrollment:
No

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