Specific Aims/Hypothesis(es) to be tested
Bacterial Vaginosis (BV) is the most common cause of vaginal symptoms among women of reproductive age, ages 15-44 years. The number of lactobacilli in the vagina of women with BV is significantly lower than that in healthy women. While some women may be asymptomatic, most experience thin, white or yellow abnormal vaginal discharge and malodor, especially after intercourse. Women with BV have an increased risk of many gynecological complications. Bacterial infections have been linked to increased risk factors for many sexually transmitted infections (STIs), including human immunodeficiency virus (HIV) infection. Women may also de-velop increase risk of second trimester miscarriage, preterm birth,
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Specific Aim 2: Document and compare adverse effects of the proposed probiotic IUD with that of metronida-zole.
Hypothesis 2: Fewer adverse events will be documented with the use of a probiotic-eluting IUD than with the typical BV treatment of metronidazole.
Specific Aim 3: Cost Analysis: Compare the costs (device, treatments and ob/gyn visits) associated with the new probiotic-eluting IUD versus typical treatment for bacterial vaginosis.
Hypothesis 3: The long term cost of treating bacterial infections in hormonal IUD users will be lower in those using the proposed probiotic housed intrauterine device.
Expected outcomes are that a hormonal intrauterine device containing Lactobacillus acidophilus will be more effective, and more cost effective than traditional treatment of metronidazole for treatment of bacterial vagi-nosis (BV) in IUD users. A steady intrauterine absorption of probiotics during early use of an IUD may reduce the incidence of a bacterial infection as well as prevent recurrence. In the long-term, this may reduce risk fac-tors for gynecological complications, viral transmission, and complications during
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BV is a condition characterized by vaginal flora imbalance, in which normally plen-tiful peroxidase-producing bacteria (Lactobacillus) are scarce and other anaerobic bacteria abundant. Among women presenting for care, BV is the most prevalent cause of vaginal discharge or malodor; however, in a nationally representative survey, most women with BV were asymptomatic. [1] BV is as-sociated with an increased risk of acquisition of sexually transmitted infections (STIs), HIV, and with ad-verse pregnancy outcomes. Although BV is associated with an increased risk of acquisition of STIs, da-ta from a 2007 study support the conclusion that bacterial vaginosis is not exclusively a sexually trans-mitted condition. [2] The prevalence in the United States is estimated to be 21.2 million (29.2%) among women ages 14–49, corresponding to 21.4 million women with BV. [1] Risk factors for acquiring BV in-clude black race, sexual activity, douching, and cigarette smoking.