Obstetrics & Gynecology

Study Title: Thrombophilia and Intrauterine Growth Restriction

IRB# 4698-05-4R2ER

The purpose(s) of the study are:

To assess the role of the maternal hemostatic system and maternal coagulation genes in intrauterine growth restriction (IUGR)
To assess the role of fetal coagulation genes in IUGR
To correlate thrombophilic risk factors from the maternal and fetal side with placental pathology

This is a case-control study conducted at three medical center sites over a period of three years. The sites are collaborating with the Hematologic Diseases Branch of the Centers for Disease Control and Prevention, which provides laboratory and epidemiological support by performing the hemostatic laboratory studies including DNA analysis, data entry, data management and statistical analysis.

Mothers age 18 or older and their infants who meet the case definition of IUGR are eligible for the study. IUGR cases will be defined as fetuses, male or female, between 24 and 40 weeks gestational age with weight less than or equal to the tenth percentile for gestational age using the Hadlock growth curves . Mothers age 18 or older and their infants who do not meet the definition of an IUGR case and who are presenting for prenatal care without any known obstetrical complications and are of the same race and at the same point in gestation (+ 2 weeks) as a case will be enrolled as controls. Inclusion is contingent upon a term live birth, i.e., greater then 37 weeks.

Study Title: A Prospective Randomized Trial of Unfractionated Heparin Versus Low Molecular Weight Heparin for Thromboprophylaxis in Pregnant Women

IRB# 1178-05-7R7

The purpose of this study is to compare the frequency of complications, recurrent thrombosis, bleeding, thrombocytopenia, osteoporosis and subcutaneous complications (bruising, hematomas, and infection) in pregnant women receiving unfractionated heparin versus those receiving enoxaparin sodium, a low molecular weight heparin. Our hypothesis is that compared with unfractionated heparin, enoxaparin sodium will provide equally effective thromboprophylaxis and cause less bone loss with no increase in complications.

The design of our study is a multi-center randomized controlled trial. Any pregnant patient less than 24 weeks gestation with an indication for heparin prophylaxis (i.e., with a prior thrombotic event and no underlying hypercoagulable state) will be eligible. Those patients with a hypercoagulable state requiring full anticoagulation would not be candidates for this study. The decision regarding the need for heparin prophylaxis will be made by the patient’s primary physician prior to the patient’s recruitment into the study. Upon enrollment, patients will be randomized 1:1 to treatment with enoxaparin sodium or standard unfractionated heparin.

Study Title: An International Registry of Pregnancies Among Women with Mechanical Heart Valves

IRB# 7291-05-5R0DB

The purpose of this registry will be to store information for future research on pregnancies among women with mechanical heart valves. Anticipated research will include studies of both the fetal and maternal outcomes of these pregnancies. No specimens will be collected. While data will be submitted from around the world, the database will be housed at Duke University Medical Center.

Women with mechanical valves are generally counseled against attempting pregnancy. If they do become pregnant, termination of pregnancy is usually offered. If they choose to pursue a pregnancy despite the risks to themselves and their fetuses, the options for anticoagulation are limited. Randomized controlled trials are unlikely to be funded due to the uncommon and high-risk nature of the problem. At a minimum, a multi-center registry of pregnant women with mechanical heart valves would provide better guidance for the management of this challenging situation.

In recognition of the need for a multi-center registry, the Women’s Issues Scientific Subcommittee of the International Society of Hemostasis and Thrombosis (ISTH) has endorsed the development of such a registry with housing here at Duke.

Study Title: Treatment and Management of Menorrhagia in Women with Bleeding Disorders

IRB# 4342-05-7R2

The purposes of this study are: (1) to estimate the prevalence of underlying bleeding disorders among women with menorrhagia presenting to academic medical centers; and (2) to collect preliminary data on the effectiveness of three different treatments for menorrhagia in women with underlying bleeding disorders in terms of changes in menstrual blood loss and quality-of-life using standard instruments.

All women with a diagnosis of menorrhagia will be screened for study eligibility. Women who consent will be officially enrolled into the study by assignment of a unique study identification number. A prospective pictorial blood assessment chart (PBAC) will be completed for the next menses after enrollment. If the PBAC score is greater than 100, then the woman will return to Dr. Lukes’ clinic for baseline quality of life instruments, bleeding history questionnaire, and diagnostic blood work for bleeding disorders.

Initially, a telephone interview will be done to see if the subject is qualified for enrollment. Next, the intervention phase begins. The initial phase involves detecting the bleeding disorder. Only women with detectable bleeding disorders, defined as any abnormality on the coagulation or platelet lab tests, will be eligible to continue with the intervention phase. There are 2 arms to the interventions:

A self-selected non-randomized arm (who will use oral contraceptives for 3 months). This involves 3 menstrual cycles with oral contraceptives followed by a washout time involving 2 cycles (no contraceptives during those 2 periods), then the woman may choose to go into the randomized arm.
A randomized arm in which women will have a 50/50 chance of receiving either tranexamic acid or desmopressin acetate. A woman will receive one of these medications for 2 menstrual cycles, then will switch over to the other arm for 2 cycles.

As outlined in the study design flow chart, several quality of life scales are used (SF36, Health Related Quality of Life, Ruta’s Menorrhagia Severity Scale, Center for Epidemiologic Studies Depression Scale). Data analysis and monitoring will be done by the CDC.

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