Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Increase in Patient Knowledge
研究概览
简要总结
There is currently limited research that addresses the unique medication safety and family planning needs among women of reproductive age with psychiatric conditions. The study will research the feasibility of a novel individualized 1-on-1 counseling session at the Gifford Clinic in the Department of Psychiatry at UCSD that will help women in this population better understand: 1) which of their medications are safe to use in pregnancy, 2) provide education regarding the importance of using contraception and which contraceptive choices are available to them, and 3) raise awareness of any drug-drug interactions that may exist between their medications and their chosen method of contraception. Patients will be given questionnaire to assess their contraceptive utilization. They will also be given a before and after quiz to allow for an objective measure of the patient's increase in knowledge regarding medication safety and contraceptive choices as a result of the investigators intervention.
详细描述
Nearly half of all pregnancies in the general population in 2006-2010 were unintended. In addition, data from the National Survey of Family Growth shows that in 2006-2010, only 62.2% of women aged 15-44 in the United States are using some form of contraception. These statistics inherently suggest a need for additional education in the general population regarding contraceptive options. It is unknown how these statistics for the general population apply to women with psychiatric conditions. In addition, reproductive age women with psychiatric diagnoses have several unique family planning considerations, some of which are outlined below:
TERATOGENICITY OF PSYCHIATRIC MEDICATIONS:
Some women with psychiatric conditions may be on medications that are not safe for use in pregnancy and therefore may require counseling on their highly effective contraceptive options. These women may also have other environmental exposures to alcohol, tobacco and illicit drugs, so this may be an additional need for counseling about risk to a potential pregnancy. Other women in this population may become pregnant and stop using their psychiatric medications because they are unaware that their medications are safe to use in pregnancy. The United States Food and Drug Administration uses the following categories to rate the safety of using various pharmaceutical agents in pregnancy: A, controlled studies in humans fail to demonstrate a risk to the fetus in pregnancy; B, no evidence of risk to fetus in animal studies but no controlled studies for use in pregnant women; C, animal studies demonstrate an adverse effect on the fetus, but no controlled studies in humans; D, positive evidence of risk to fetus in human studies; and X, agent contraindicated in pregnancy because risks to fetus clearly outweigh potential benefits. Most psychotropic drugs used to treat bipolar disorder are category C or D. For example, lithium, a commonly prescribed mood stabilizer used as a first-line treatment for bipolar disorder, is associated with an increased risk of congenital cardiac abnormalities and is FDA category D for use in pregnancy. Also, valproate and carbamazapine, which are commonly used as mood stabilizers, have been associated with neural tube defects in the fetus and thus are also FDA category D for use in pregnancy.
CONTRACEPTION:
Women in this population may also wish to delay or avoid pregnancy due to the current state of their psychiatric condition and thus should be encouraged to use effective contraception. It has been shown that women with psychiatric diagnoses may interrupt their use of contraception due a variety of factors including: drug-drug interactions with their psychiatric medication, psychiatric hospitalization, loss of personal control over their medication administration, and preconceived notions of how contraception may impact their psychiatric condition or vice versa. Long-acting reversible contraceptive options, such as intrauterine devices (IUDs), requiring no patient compliance to achieve maximal efficacy may therefore be particularly well-suited options for these women. For these reasons, there may be a role for focused counseling in this population regarding options for safe, effective and reversible forms of contraception.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presenting for follow up psychiatric visit
- •Ethnic Background: will include only english speaking participants (MotherToBaby counselors are only able to speak English)
- •Level of Education: No limitation
- •Health Status: at least one psychiatric condition for which they are taking medication
- •Sexually active with Men
排除标准
- •Planning to become pregnant
- •Not sexually active with men
- •History of hysterectomy, bilateral oophorectomy, or surgical sterilization
- •Decisionally impaired - using post-consent instrument to assess decisional capacity. If a potential participant does not score 100% on post-consent instrument, then she will be excluded from participation.
结局指标
主要结局
Increase in Patient Knowledge
时间窗: 1 year
Assessed with score delta between Pre-counseling and Post-counseling Quizzes
次要结局
- Contraceptive Plans(1 year)
- Baseline Medication Safety Knowledge(1 year)
- Utilization of Contraception(1 year)
研究者
Sheila Mody
Faculty
University of California, San Diego
