Obstetrics & Gynecology Research University of Chicago

Mosaic in the Chicago Lying In Lobby

Gene Changes in Unexplained Recurrent Early Pregnancy Loss: IRB #15050B
Description and inclusion criteria

Environmental Factors Associated with Recurrent Pregnancy Loss:
IRB #14119B Description and inclusion criteria

The PROMISSE Study: (Predictors of pRegnancy Outcome: bioMarkers In antiphospholipid Syndrome and Systemic lupus Erthematosus):
IRB 14037A Description and inclusion criteria

Intravenous Immunoglobulin for Secondary Recurrent Miscarriage: A Randomized Controlled Trial: IRB: #13157A Description
Closed to enrolling new subjects

Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy: IRB: #13677B Description and inclusion criteria

Gene Changes in Unexplained Early Recurrent Miscarriage: IRB #15050B

Study Summary
The purpose of this study is to learn more about the possible cause(s) of miscarriage. Even with thorough evaluation and testing, the reasons for a miscarriage can only be determined in about 60% of cases. By performing a more powerful test on the genetic material (inherited substances responsible for our unique characteristics) from miscarriage tissue, we expect to find changes in some samples that are not detected by the testing routinely done on this tissue. We also expect that studying changes in miscarriage tissue found by this newer method and comparing them to changes that may be found in the parents’ genetic material, will lead to a greater understanding of why some pregnancies do not progress.
Couples evaluated by Dr. Stephenson at the University of Chicago’s Recurrent Pregnancy Loss Program for a history of pregnancy loss will be asked to participate if routine testing of their miscarriage tissue has shown a normal result. Permission will be sought to allow re-testing of the genetic material from miscarriage tissue using a newer, more powerful technology. If this re-test finds changes in the miscarriage tissue, we will send genetic material from the couple for similar testing, to determine whether either also carries this change.
The benefits of participating in this study include contributing to medical research designed to answer some very important questions about inherited factors and recurrent pregnancy loss.

Participation Details
Inclusion criteria for the study include:

At least two unexplained, consecutive miscarriages of less than 12 weeks with the same partner
Normal chromosome test result for most recent miscarriage
Other reasons for recurrent early pregnancy loss have been ruled out
Both parents able to undergo testing

Study Director: Mary D. Stephenson, MD, MSc
Department: Obstetrics and Gynecology
For more information, contact:
Patricia A. Schultz, RN, MHA
Recurrent Pregnancy Loss Research Office
University of Chicago – Dept. of OBGYN
5841 S. Maryland Ave. (MC 2050)
Chicago, IL 60637
Phone (773) 834-2106

Environmental Factors Associated with Recurrent Pregnancy Loss: IRB #14119B

Recurrent pregnancy loss is a prevalent health problem that affects many couples trying to establish a family. Preliminary evidence suggests that exposure to environmental factors may impact the outcome of pregnancy. Some of the suspected environmental factors include: exposure to heavy metals such as lead and mercury, organic solvents, alcohol, radiation, and possibly caffeine, cigarette smoke, pesticides, and fever. Further evidence is needed to determine whether such exposures are significant in respect to pregnancy loss.

The purpose of this study is to examine the possible associations between various environmental factors in patients with a history of pregnancy loss.

Women who have been evaluated by Dr. Stephenson at the University of Chicago’s Recurrent Pregnancy Loss Program for a history of recurrent pregnancy loss, will be asked to complete a survey with questions about exposure to environmental factors for each pregnancy.

The benefits of participating in this trial include contributing to medical research designed to answer some very important questions about environmental factors and recurrent pregnancy loss.

Participation Details
Inclusion criteria for the study include:

Women ages 18 and 44 years of age
History of at least two or more miscarriages

Study Director: Mary D. Stephenson, MD, MSc
Department: Obstetrics and Gynecology, Reproductive Endocrinology & Infertility

For more information, contact:
University of Chicago – Dept. of OBGYN
Section of Reproductive Endocrinology & Infertility
5841 S. Maryland Ave. (MC 2050)
Chicago, IL 60637
Phone (773) 702-6642

The PROMISSE Study: IRB 14037A
(Predictors of pRegnancy Outcome: bioMarkers In antiphospholipid Syndrome and Systemic lupus Erthematosus)
This trial is supported by the National Institute s of Health and the University of Chicago’s National Institute of Health ( NIH ) General Clinical Research Center (GCRC)
Study Summary
The antiphospholipid syndrome (APS) and systemic lupus erythematosus (SLE) are associated with problems in pregnancy. It is not known why these problems occur or how they can be prevented. The University of Chicago and Dr. Mary Stephenson, as well as other investigators at seven other major clinical centers around the U.S. and Canada, are conducting a clinical study to find out whether increased amounts of certain proteins in the blood that can injure healthy organs can be used to predict whether or not pregnant women with APS and/or SLE will have a healthy pregnancy.

If you decide to participate you will be involved in the study from approximately 6 weeks of pregnancy until approximately 3 months post partum. If it is determined that you are eligible, you would

Have research blood and urine tests done every 4-6 weeks in pregnancy
If you have SLE, you would have a research assessment for disease activity 3 times during pregnancy and once post partum

There will be no charge for the study-related procedures. The cost of routine care prior to, during, and after pregnancy will be the participant’s responsibility.

The benefits of participating in this trial include the possibility of helping Dr. Stephenson and her colleagues better understand how problems in pregnant women with APS and/or SLE occur. If the investigators find that inflammatory proteins in blood predict problems in pregnancy, then such blood tests may be used to predict complications in other pregnant patients with APS and SLE. The result of this study may also lead to better treatments for pregnancy loss in such women .

Participation Details
Initial selection criteria for the study include:

18 - 45 years of age
Less than 3 months pregnant
Presence of antiphospholipid antibodies and/or systemic lupus erythematosus

Study Director: Mary D. Stephenson, MD, MSc
Department: Obstetrics and Gynecology, Reproductive Endocrinology & Infertility

For more information, contact:
Patricia A. Schultz, RN, MHA
University of Chicago – Dept. of OBGYN
Section of Reproductive Endocrinology and Infertility
5841 S. Maryland Ave. (MC 2050)
Chicago, IL 60637

Intravenous Immunoglobulin for Secondary Recurrent Miscarriage: A Randomized Controlled Trial IRB: #13157A
This trial is supported by the University of Chicago’s National Institute of Health (NIH) General Clinical Research Center (GCRC).

Study Summary
Recurrent miscarriage is a prevalent reproductive problem that affects many couples who are trying to establish a family. The University of Chicago and Dr. Mary Stephenson are conducting a clinical study to evaluate the effectiveness of intravenous immunoglobulin (IVIG) in improving the live birth rate in couples who suffer from secondary recurrent miscarriage. IVIG is not a new medication, it is used for many immune disorders. While IVIG has not received approval for use in treating recurrent miscarriage, recent evidence suggests it may be helpful in improving the mother’s immune response to pregnancy. This study will help in providing an answer to the question of whether IVIG is helpful in secondary recurrent miscarriage.

Participants will be assigned by chance to receive either intravenous IVIG or salt water (an inactive substance). The intravenous (IV) solutions are given once monthly during the first half of the menstrual cycle until pregnancy is achieved, and then every 4 weeks until 5 months of pregnancy. If pregnancy does not occur within 6 cycles, participation in the study will stop. Each IV solution requires up to 6 hours to administer. Participants will also be asked to return weekly for blood draws 3 times during the study.

Dr. Stephenson and her research staff will monitor the pregnancy closely during the first trimester. The patient will then be transferred back to the referring physician for the remainder of the pregnancy.

There will be no charge for the study-related procedures, study-related care or study drug. The cost of routine care prior to and during pregnancy will be the participant’s responsibility. The study procedures and study follow-up will all be performed at the University of Chicago Hospitals.

The benefits of participating in this trial include the possibility of improving the chance of having a successful pregnancy. In addition, participants would contribute to the advancement of recurrent miscarriage research, in particular with respect to some important questions about the maternal immune responses to pregnancy.

Participation Details

Initial selection criteria for the study include:

Women between 18 and 44 years of age
History of a successful pregnancy followed by at least three miscarriages, all conceived with the same partner.
Genetic, endocrine, anatomical and autoimmune factors associated with recurrent miscarriage have been ruled out.

Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy
IRB: #13677B
This trial is supported by the University of Chicago’s Women’s Board and the University of Chicago’s National Institute of Health (NIH) General Clinical Research Center (GCRC)
Study Summary
Some women with a history of pregnancy loss are also at risk for developing blood clots in pregnancy (a condition called thrombophilia). A thrombophilia can be acquired, specifically antiphospholipid syndrome (APS), or inherited. The standard treatment in pregnancy is heparin and low dose aspirin, in some cases. The University of Chicago and Dr. Mary Stephenson are conducting a clinical study to further clarify the best doses of heparin that are advisable for use in treating this problem in pregnancy. While heparin has been shown to improve pregnancy success in such women, there has been limited research on how heparins are handled by the body during pregnancy. The evaluation of the body’s handling of a drug is called pharmacokinetics.

Participants will be allowed to choose whether they wish to be treated with unfractionated heparin (UFH) or low molecular weight heparin (LMWH). The only study procedure beyond the care that is routinely provided includes 12-13 hour visits to the University of Chicago’s General Clinical Research Center once prior to pregnancy, once during each trimester and once after delivery. During these study visits, a small amount of blood will be drawn at specific times to measure the effect of the heparin over time.

There will be no charge for the study-related procedures. The cost of routine care prior to, during and after pregnancy will be the participant’s responsibility. The study procedures will all be performed at the University of Chicago Hospitals.

The benefits of participating in this trial include the possibility of helping Dr. Stephenson better understand how a participant’s body handles heparin. This understanding is especially important if/when heparin is given with another pregnancy. Additionally, Dr. Stephenson and her research team will use the data from this study to determine the best dosing for heparin use in pregnancy. This may benefit many other women who require heparin in pregnancy.

Participation Details

Initial selection criteria for the study include:
Women between 18 and 44 years of age

Diagnosis of antiphopholipd syndrome or an inherited thrombophilia.
Able to safely undergo treatment with heparin.

Study Director: Mary D. Stephenson, MD, MSc
Department: Obstetrics and Gynecology

For more information, contact:
Recurrent Pregnancy Loss Nurse
University of Chicago – Dept. of OBGYN
Section of Reproductive Endocrinology and Infertility
5841 S. Maryland Ave. (MC 2050)
Chicago , IL 60637
Phone (773) 702-6642