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RESEARCH PROJECTS
  1. Contraceptive Efficacy and Disposition in Obese and Non-obese Women and Adolescents
    Oral contraceptives are known to fail more often in obese women. The reasons why are not clearly understood. This study will compare measures of efficacy and disposition of an oral contraceptive between women of healthy weight and obese weight as measured by Body Mass Index. Women will take their contraceptive for at least 2 cycles and will then be evaluated during the third cycle on the pills. They will have ultrasound measurements of ovarian follicle development early in the cycle. Around cycle day 21, subjects will be admitted for an overnight stay at the GCRC for blood work to be drawn to measure levels of the medication and its breakdown products in the blood. Comparisons of follicle development and blood hormone levels will be made between the two groups with 20 women in each group.

  2. A retrospective study of depression and antidepressant use in an inner-city obstetric population
    The Department of Obstetrics and Gynecology and the Division of Clinical Pharmacology at Indiana University plan to conduct a retrospective chart review to study the prevalence of depression and antidepressant use in the obstetric population at Wishard Hospital. In addition, we will investigate for correlations between maternal and fetal outcomes with depression and antidepressant use in this population. To date there is little information in the literature characterizing the epidemiology of depression and antidepressant use in an inner city obstetric population. The data from this study will provide a useful foundation for further investigation of depression in pregnancy.

  3. A study of the pharmacogenetics of nausea and vomiting of pregnancy
    The objective of this study is to demonstrate that response to antiemetic medications in the treatment of nausea and vomiting of pregnancy (NVP) is related to genetic changes related to how individual women's bodies handle the medications. Pregnant women who have newly diagnosed NVP and are starting medication for treatment of NVP will be recruited into the study from clinics affiliated with Indiana University and Clarian Health Partners. Subjects will have DNA collected for analysis of potential genetic changes related to how they handle the medications upon study entry. In addition, severity of the NVP based on symptoms will be calculated at baseline and one week after starting the medications. Serum will also be collected for other tests that may help us to get a better understanding of how well the medications work. One-hundred subjects will be recruited to this study.

  4. The pharmacokinetics of nifedipine for preterm labor tocolysis
    The objective of this project is to characterize the blood concentrations or levels of nifedipine in pregnant women when used to help stop preterm labor. Pregnant women who are admitted and treated for preterm labor with nifedipine will have blood samples obtained to allow description of the absorption, distribution and elimination of the drug. In addition, we will test for association between known genetic changes in the enzymes that metabolize nifedipine and other enzymes and transporters potentially involved in how women handle nifedipine and its efficacy during pregnancy.

  5. Study of the pharmacokinetics and pharmacogenetics of selective serotonin reuptake inhibitors during pregnancy
    The amount or levels of some antidepressant medications in the blood (e.g. selective serotonin reuptake inhibitors or SSRIs) seems to be decreased during pregnancy. If the levels of SSRIs in the blood are low, the medication may not be adequately treating depression. The objective of our study is to evaluate whether pregnant women have decreased levels of SSRIs and a resultant decreased improvement of depression with SSRIs. We also want to evaluate whether variations in the genes related to how the body eliminates the SSRIs or how the SSRIs work influence the improvement in depression pregnant women get from these drugs. We will conduct a study in 75 pregnant women who are receiving fluoxetine (n = 25) or citalopram (n = 25) for the treatment of depression, or who are not receiving any medication for depression (n = 25). Participants will be enrolled any time before 26 weeks of pregnancy. Blood samples will be collected for drug level measurements and genetic analysis. In addition, the scores of a rating scale to measure the severity of depression and two rating scales to measure the undesirable effects of the treatment will be obtained on enrollment and monthly for up to 12 weeks after delivery. Maternal and umbilical cord blood samples will be obtained at delivery for determination of SSRI levels, platelet serotonin levels (a marker that SSRIs are working) and for collection of neonatal DNA. Clinical data related to pregnancy and neonatal health will be obtained from the prenatal and neonatal charts.

  6. Pharmacogenetics of antenatal corticosteroids in preterm birth
    This 3-part project examines genetic variation in pregnant women and newborns as a source of differences in neonatal response to steroids given to pregnant women to help mature the baby's lung more rapidly. This project also examines physician practice patterns and will form the basis for an interventional study to utilize genetic information to determine the optimal dose and timing of this beneficial therapy.

  7. Genetic polymorphisms in the angiogenic pathway and preeclampsia
    The importance of the angiogenesis pathway is becoming evident in the etiology of preeclampsia. Genetic variation in the genes of that pathway may play a key role in determining not only which women develop preeclampsia, but how severe their disease becomes. Unlocking the key genetic variants in the pathophysiology of preeclampsia may lead to developing more targeted prevention and treatment strategies.

  8. Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized Controlled Trial
    This project will examine the effect of vaginal cleansing before cesarean delivery on the postoperative infection and wound complication rate. This randomized controlled trial will involve 1000 women at University Hospital, Wishard Hospital, and Methodist Hospital in Indianapolis.