Family Planning & Preventive Services
Prenatal Blood Test for Fetal Aneuploidy Detection
The majority of the 6.4 million women in the U.S. who become pregnant each year have maternal serum screening and /or an ultrasound examination to determine risk for common birth defects, such Down syndrome, Edwards syndrome, and sex chromosomal abnormalities. However, the current screening tests have false positive rates between 5-20% and false negative rates up to 30%, leading to a significant number of invasive diagnostic testing procedures and heightened maternal anxiety and stress. Given that prenatal diagnosis is critical in guiding medical care for both the mother and fetus, a more accurate noninvasive test is needed. This study aims to help develop and evaluate a prenatal blood test using cell-free fetal DNA, which is present in maternal blood at significantly higher amounts than fetal cells, and therefore has the potential to be utilized for detection of fetal chromosomal abnormalities.
Epilepsy LNG IUS
Medical guidelines recommend effective birth control for the 500,000 women with epilepsy (WWE) in the U.S. who are of childbearing age, to prevent exposure to epilepsy medicines that cause birth defects and control seizures before pregnancy. Birth control for WWE is challenging, as some epilepsy medicines make hormonal birth control less effective. The levonorgestrel intrauterine system (LNG IUS) is an IUD that secretes the hormone progestin into the uterus, providing effective, low-maintenance, reversible birth control for healthy women. However, this birth control has not been studied in WWE; their epilepsy medications may alter how the LNG IUS works and menstrual bleeding, thus potentially affecting its safety and effectiveness for this population. This exploratory study of 20 WWE starting the LNG IUS will measure hormones, seizures, menstrual bleeding, ovulation and acceptability.
Intrauterine devices or systems (IUDs) are considered to be a highly effective, long-term, reversible contraception which is effective immediately after insertion, providing contraceptive benefits for several years; when removed, the return to fertility is rapid. However, based on the latest estimates from 2002, IUDs are used by only 2% of women (approximately 800,000) in the United States practicing contraception. Some barriers to greater use of IUDs in the U.S. include out-of-pocket costs, provider biases, and lack of information (or misinformation) about the safety and effectiveness of current IUDs. This is a Phase 3, randomized, open-label, multi-center evaluation of the efficacy of a levonorgestrel-releasing intrauterine device system (LNG20), the goal of which is to develop and obtain U.S. regulatory approval for LNG20, and to secure sustainable access for the public at an affordable price. In the United States, LNG20 is expected to provide safe and effective contraception for five or more years.
Nestorone® /Estradiol Releasing Vaginal Ring
Until recently, all hormonal contraceptives contained ethinyl estradiol (EE), a potent synthetic estrogen. EE is known to induce metabolic changes, including stimulating the synthesis of hepatic proteins such as low and high-density lipoproteins, and hemostatic or clotting factors. A need exists to offer women a new contraceptive system that is user-controlled, easy to use, and associated with high rates of contraceptive efficacy, safety, and adherence. A new vaginal delivery system made of silicone rubber containing Nestorone®, a 19 nor progesterone derivative, and three doses of estradiol is being tested for safety, efficacy, and bleeding profile in normal cycling women. The aim is to offer a contraceptive that does not require daily action by users and has an acceptable safety profile. A contraceptive vaginal ring (CVR) containing two steroids that are equal or very comparable to the physiologic ovarian hormones estradiol and progesterone, respectively, may be safer than a hormonal method using EE. This study will test three parallel CVR groups to demonstrate bleeding patterns, ovulation suppression, absorption and safety.