Term
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Definition
| a delivery system; first point of entry into the health care system. Delivers holistic care in a collaborative manner; the activity of the health care provider |
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Term
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Definition
| accessibility and fairness; relevance to the needs of the population. Essential health care based on EBR, sound and socially acceptable methods, and technology made universally accessible to all |
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Term
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Definition
| Proportion of population that is initially free of disease but develops over time |
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Term
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Definition
| Proportion of population possessing a clinical condition at a point in time |
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Term
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Definition
| prevents the onset of a targeted condition; health promotion, implement lifestyle changes |
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Term
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Definition
| identify & treat asymptomatic ppl who have the risk factors, but the condition is not readily apparent |
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Term
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Definition
| care of established disease “maintenance” |
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Term
| Strongest Predictor of Health Status |
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Definition
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Term
| HbA1C, medications, INR/PT/PTT, med levels (theophylline, digoxin) |
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Definition
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Term
| Screening: BSE, mammography, colonoscopy, PAP, FOBT |
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Definition
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Term
| Immunizations, Health protecting education: seat belts, helmets, etc |
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Definition
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Term
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Definition
| Negative predictor: the probability that the test will be negative among pts who do not have the disease |
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Term
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Definition
| Positive predictor; the probability that the test is positive when given to a group of pts who have the disease |
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Term
| Positive Predictive Value |
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Definition
| the probability that the pt who tested positive for the disease actually has the disease |
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Term
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Definition
| Add 1 week to the 1st day of the LMP and subtract 3 months |
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Term
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Definition
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Term
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Definition
| bluish discoloration of vaginal mucosa |
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Definition
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Definition
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Term
| Height increases at basal rate: 5-6 cm/year Breast: Papilla elevation only Pubic Hair: Villus hair only No coarse, pigmented hair |
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Definition
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Term
| Height increases at accelerated rate: 7-8 cm/year Breast: Breast buds palpable and areolae enlarge Age 10.9 years (8.9-12.9 years) Pubic Hair: Minimal coarse, pigmented hair mainly on labia Age 11.2 years (9.0-13.4 years) |
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Definition
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Term
| Height increases at peak rate: 8 cm/year (age 12.5) Breast: Elevation of Breast contour; areolae enlarge Age 11.9 years (9.9-13.9 years) Pubic Hair: Dark, coarse, curly hair spreads over mons pubis Age 11.9 years (9.6-14.1 years) Other changes Axillary hair develops (13.1 years) Acne Vulgaris develops (13.2 years) |
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Definition
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Term
| Height increases at 7 cm/year Breast: Areolae forms secondary mound on the Breast Age: 12.9 years (10.5-15.3 years) Pubic Hair: Hair of adult quality No spread to junction of medial thigh with perineum Age: 12.6 years (10.4-14.8 years) |
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Definition
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Term
| No further height increases after age 16 years Breast: Adult Breast contour Areola recesses to general contour of Breast Pubic hair: Adult distribution of hair Pubic hair spreads to medial thigh Pubic hair does not extend up linea alba |
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Definition
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Term
| Height increases at basal rate: 5-6 cm/year Testes: Smaller than 4 ml or long axis <2.5 cm Pubic Hair: No coarse, pigmented hair Penis Stage: No growth |
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Definition
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Term
| Height increases at basal rate: 5-6 cm/year Testes Size: 4 ml or long axis 2.5 to 3.2 cm Age 11.5 years (age 9.5 to 13.5 years) Pubic: Hair Minimal coarse, pigmented hair at base of penis Age 12.0 years (age 9.9 to 14.0 years) Penis Stage: Earliest increased length and width Age 11.5 years (age 10.5-14.5 years) |
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Definition
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Term
| Height increases at accelerated rate: 7-8 cm/year Testes Size: 12 ml or long axis 3.6 cm Age 14.0 years (11.5-16.5 years) Pubic Hair: Coarse, dark curly hair spread over the pubis Age 13.1 years (11.2-15.0 years) Penis Stage: Increased length and width Age 12.4 years (10.1-14.6 years) Other Changes Gynecomastia may occur (age 13.2 years) Voice breaks (age 13.5 years) Muscle mass increases |
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Definition
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Term
| Height increases at peak rate: 10 cm/year (age 13.8) Pubic Hair: Hair of adult quality Not spread to junction of medial thigh with perineum Age 13.9 years (12.0-15.8 years) Penis: Continued growth in length and width Age 13.2 years (11.2-15.3 years) Testes: Length 4.1 to 4.5 cm Other Changes Axillary hair (age 14.0 years) Voice changes (age 14.1 years) Acne Vulgaris (age 14.3 years) |
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Definition
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Term
| No further height increases after age 17 years Pubic Hair: Adult pubic hair distribution (15.3 years) Pubic hair spreads to medial thigh No hair spread to linea alba Penis: Mature genital size by 16.5 years Testes: Length >4.5 cm Secondary sexual characteristics Facial hair present on sides Mature male physique Gynecomastia disappears |
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Definition
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Term
| True or False: BPH is a normal age variant? |
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Definition
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Term
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Definition
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Term
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Definition
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Term
| Women should not be pelvic screened regardless of the age of sexual initiation or other risk factors? |
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Definition
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Term
| Recommends at what ages screening with cytology every 3 years. |
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Definition
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Term
| Recommends screening with cytology every 3 years or for women who want to lengthen the screening interval, screening with a combination of cytology and HPV testing every 5 years. |
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Definition
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Term
| Recommends against screening women who have had adequate prior screening and are not otherwise at high risk for cervical cancer. |
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Definition
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Term
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Definition
| Recommends against screening in women who have had a hysterectomy with removal of the cervix and who do not have a history of a high-grade precancerous lesion (ie, CIN 2 or 3) or cervical cancer. |
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Term
| Should women who have had the HPV vaccine continue to be screened? |
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Definition
| Yes: Women who have been vaccinated should continue to be screened |
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Term
| Visits should include personal history, blood pressure, body mass index (BMI), physical exam, preventive screening, and counseling how often |
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Definition
| ages 18–21 Every 1–3 years, depending on risk factors 50+ Annually |
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Term
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Definition
Colonoscopy at age 50 and then every 10 years, or annual fecal occult blood test (FOBT) plus sigmoidoscopy every 5 years, or sigmoidoscopy every 5 years, or double-contrast barium enema every 5 years
Unless high risk and then begin age 45 |
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Term
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Definition
| 18-40:Annual clinical breast exam and monthly self-exam 40+ Annual mammography at discretion of clinician |
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Term
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Definition
| age 21 every 1–3 years, depending on risk factors |
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Term
| Testicular and Prostate Cancer |
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Definition
| 18-40: Clinical testicular exam at each health maintenance visit and monthly self-exam 40+ PSA at risk only until age 50. Digital rectal annually. |
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Term
| You have pap results what do you do now? |
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Definition
| If no endo-cervical cells noted If previous Pap smears normal and woman is at low risk. May wait and repeat in one year If hx of abnormal pap smear, at risk or previous pap did not show endo-cervical cells, repeat in 3 months and pay attention to technique If organisms noted, treat appropriately. |
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Term
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Definition
| Epithelial cell abnormality: atypical squamous cells of undetermined significance |
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Term
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Definition
| Epithelial cell abnormality: atypical squamous cells, can’t rule out HSIL |
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Term
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Definition
| Epithelial cell abnormality: glandular cells, atypical glandular cells |
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Term
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Definition
| Epithelial cell abnormality: low grade squamous intraepithelial |
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Term
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Definition
| Epithelial cell abnormality: high grade squamous intraepithelial lesion |
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Term
| What do you do as the Np if you get the following result on a pap: ASC-US |
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Definition
| HPV or Repeat in 6-12 months or Colpo |
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Term
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Definition
| Colpo in 21 and older in postmenopausal HPV or Repeat in 6-12 months or colpo |
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Term
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Definition
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Term
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Definition
| Colpo without endocerv sampling in pregnant women. |
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Term
| Result: AGC all subcategories |
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Definition
| HPV, colpo and endoserv sampling |
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Term
| When teaching about BC pills your pt tells you that she has forgotten to take 2 days worth of pills how do you advise her? |
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Definition
| Continue taking pills as prescribed, but use additional form of birth control for the remainder of the cycle |
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Term
| What time of the day do you teach patients to take OCP? |
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Definition
| Take OCP at the same time every day to ensure efficacy |
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Term
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Definition
| Begin screening high risk persons at age 20, men at 30 and women at 45 |
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Term
| What to do with elevated PSA? |
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Definition
| Repeat and know what to tell patient when they come back for repeat labs (no intercourse, bike riding, anything that would cause trauma) always draw PSA prior to DRE |
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Term
| What is the difference between monophasic, biphasic and triphasic OCP? |
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Definition
| Monophasic is one with steady rate of hormones, biphasic and triphasic mimics normal cycle (triphasic more closely mimics normal phase) |
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Term
| A patient comes in with c/o breast tenderness after beginning an OCP what should you do? |
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Definition
| Wait 12 weeks as these symptoms may resolve. |
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Term
| When teaching a pt about what to do after taking osteoporosis medications you would teach...? |
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Definition
| Maintain upright for at least 30 minutes, full glass of water, reflux and nausea are common side effects |
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Term
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Definition
| A standardized scale for the estimation of newborn gestational age by neurological examination. The full exam is very extensive and scores 33 specific responses in four major areas: habituation (response to repetitive light and sound stimuli), movement and tone, reflexes, and neurobehavioral items. |
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Term
| Spiritual interventions... |
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Definition
| touch of hand, nod of affirmation, look of full/complete attn. (exuding presence). Does not allow for provision of spiritual practices. |
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Term
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Definition
| • Precontemplation (Not Ready)-"People are not intending to take action in the foreseeable future, and can be unaware that their behavior is problematic" • Contemplation (Getting Ready)-"People are beginning to recognize that their behavior is problematic, and start to look at the pros and cons of their continued actions" • Preparation (Ready)-"People are intending to take action in the immediate future, and may begin taking small steps toward behavior change” i.e.: Concrete steps of cutting down on smoking • Action – "People have made specific overt modifications in modifying their problem behavior or in acquiring new healthy behaviors" • Maintenance – "People have been able to sustain action for awhile and are working to prevent relapse" • Termination – "Individuals have zero temptation and they are sure they will not return to their old unhealthy habit as a way of coping Preparation stage (Identify what patient actions represent stage) |
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Term
| When teaching a pregnant woman about Mercury, what fish should she avoid? |
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Definition
| Avoid: Fish/shellfish: shark, swordfish, king mackerel, or tilefish, & albacore tuna |
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Term
| Patterns of relating tend to repeat themselves; focus is on various actions of the family |
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Definition
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Term
| A more simplified maturity rating scale for estimating newborn gestational age. It consists of six evaluation areas for neuromuscular maturity and seven items of observed physical maturity. It is the scale probably most often used in the nursery. |
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Definition
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Term
| Ability of a test to distinguish who has a disease and who does not. |
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Definition
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Term
| Study of the distribution and determinants of health-related states or events in specified populations and the application of this study to the control of health problems. |
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Definition
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Term
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Definition
| Number of new cases of “D” disease divided by the total population at risk |
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Term
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Definition
| Number of deaths from “E” disease divided by the total population at risk |
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Term
| 3 Key Elements of Environmental Exposure |
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Definition
| 1.PHYSICAL: physical characteristics equate to biomarkers, blood test, and chemicals that are screened through blood testing. Sometimes s/s are a result of an envm exposure & not necessarily family history. 2.BIOLOGICAL ELEMENTS: exposure to a chemical in the envm. (lead/pesticides) 3.SOCIOECONOMIC STATUS: evidence that indicates ppl living in lower level of socioeconomic statuses are more likely to exposures & are more likely to have chronic diseases & to die as a result of these envm exposures |
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Term
| APN responsibility in regards to environment |
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Definition
| assess & identify the risk and prevent exposures |
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Term
| Emphasizes the organization or structure of the family and how this structure facilitates family functioning. Examines the relationship btwn family members as they relate to carrying out family functions. |
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Definition
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Term
| Emphasis on the identification of actual and potential problems & delineation of intervention strategies that maximize efficient and effective system operation. Systems can be OPEN or CLOSED. |
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Definition
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Term
| Focuses on present interactions; to modify the present not focus on the past. |
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Definition
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Term
| Longitudinal; emphasizes growth, development, & maturation. Focus on: identification of actual and potential developmental problems & delineation of intervention strategies to foster maximum growth & development. Major thrust is change; and the change is directional |
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Definition
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Term
| Duvall’s Family Life Cycle 8 STAGES: |
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Definition
| 1. Beginning Family 2. Childbearing Family 3. Family w/ preschool children 4. Family w/ school age children 5. Family w/ teens 6. Family launching young adults 7. Family w/ middle-age parents 8. Family in retirement & old age |
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Term
| Limitations of developmental theory |
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Definition
| Doesn’t address situational stressors or unusual events. Assumes the family is homogenous, middle class, & stable in each stage. Doesn’t describe the processes in between stages that allow the family to change. |
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Term
| The stage of change when the patient is not considering change. |
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Definition
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Term
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Definition
| Patient shows awareness of a problem. |
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Term
| Stage when the patient says, “I've got to do something.” |
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Definition
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Term
| Stage when patient stops smoking. |
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Definition
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Term
| Stage at which patient sustains change. |
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Definition
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Term
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Definition
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Term
| 4 A's of Smoking Assessment |
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Definition
| Ask about smoking at every visit. Advise patients of the health benefits of quitting smoking (e.g., “As your health care provider, I must advise you to stop smoking now”). Assist the patient in stopping. Identify and remove any barriers to treatment. Arrange a follow-up visit. |
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Term
| defined as a set of “patterns, explicit and implicit, of and for behavior.” It is “acquired and transmitted by symbols” and is based on “traditional (i.e., historically derived and selected) ideas |
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Definition
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Term
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Definition
| Swelling of the scalp in a newborn. It is most often brought on by pressure from the uterus or vaginal wall during a head-first (vertex) delivery. Can cross suture lines. |
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Term
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Definition
| This is a collection of blood from broken blood vessels that builds up under the scalp. Does not cross suture lines. |
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Term
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Definition
| • Birthweight less than 2500g or greater than 4000g • Birth before 37 or after 42 weeks GA • Small or large for GA • Hypoglycemia • Tachypnea, cyanosis • Congenital malformations • Pallor, Plethora, Petechiae |
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Term
| Parents of a 3 months old child come into the office stating that child has a bulge on her bellybutton. You assess and note that the child has an umbilical hernia, what would be appropriate teaching of these parents in regards to umbilical hernias? |
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Definition
| • Most umbilical hernias resolve spontaneously by 1 year old, but can take up to 4-5 years. • Counsel parents to avoid taping coins or placing bellybands over the umbilicus because these efforts do not help and can contribute to infection. |
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Term
| A mother brings her 3 year old son into the office and you notice that the child has multiple bruises in various stages of healing to shins and even a large bruise to forhead, what do you suspect about this child? |
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Definition
| These are normal bruising patterns for this developmental age group. |
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Term
| When would you screen a child for anemia? |
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Definition
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Term
| Components of the HEADSS exam |
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Definition
| • H: Home • E: Education • A: Activities • D/D: Drugs/drinking • S: Sex and sexuality • S: Suicide and mental health thoughts |
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Term
| Anticipatory Guidance: Adolescents |
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Definition
| Accident prevention: Correct and consistent use of helmets, seat belts, and proper sports equipment should be taught and encouraged. Weapons: Access to guns and other weapons should be restricted, with emphasis on safety and responsibility. |
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Term
| A 16 year old female comes into the office for a well exam upon looking through her chart what is one of the things that you would recommend for this age group for primary prevention. |
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Definition
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Term
| The 3 main causes of death in young adulthood are |
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Definition
| unintentional injury (MVA death is #1 & greater in men than women), homicide (highest in men & African Americans), suicide (5 times higher in men than women). |
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Term
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Definition
| reliable, easy to use, easily available, not related to intercourse, safe, reversible and cost effective. |
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Term
| A couple come into your clinic after the husband has undergone a vasectomy. You would provide what teaching in regards to birth control immediately following this procedure? |
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Definition
| Use barrier/alternative method for a few months after as it takes awhile for the sperm to be ejaculated or reabsorbed. Must have sperm analysis with sperm count of zero before discontinuing use of alternative method |
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Term
| An 18 year old female presents to the clinic for her depo shot stating that she had to miss her follow up injection 3 weeks ago because she was out of town. What would be the most appropriate action of the NP? |
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Definition
| Perform a pregnancy exam, if negative give injection. |
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Term
| A 19 year old female patient presents to the clinic after obtaining the Depo shot 4 weeks ago stating she has been gaining weight, having irregular periods and depression. How would you advise this pt? |
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Definition
| Nothing can be done to reverse but should wear off in 12-14 weeks |
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Term
| Contraindications of OCP? |
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Definition
| • Known or suspected pregnancy • Undiagnosed abnormal vaginal bleeding • Migraine with aura • Uncontrolled/poorly controlled HTN • Gallbladder disease • Hyperlipidemia (very high triglycerides and cholesterol can be worsened by estrogen) • Smokers over the age of 35 • Impaired liver function/hepatic disease • Clotting disorders, including a close family history • Known or suspected breast cancer |
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Term
| Warning signals to watch for while on pill |
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Definition
| A: abdominal pain (severe) Blood clot in pelvis or liver, benign liver tumor/gallbladder disease C: Chest pain (severe) Blood clot in lungs, heart attack, angina, breast lump H: Headaches (severe) Stroke, migraine with aura, high BP E: Eye problems (severe) Stroke, blurred vision, migraine with aura, blood clot in eye S: Leg pain (severe) Calf or thigh, inflammation or blood clots in vein of leg |
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Term
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Definition
| Causes endometrium to thin and cervical mucus to thicken. Must be taken daily at exact same time every day. Immediate return to fertility May take while breast feeding. Okay in pts with migraine/aura, clot history, smoker |
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Term
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Definition
| Annual Fecal Occult blood test (FOBT) • Flexible sigmoidoscopy (every 5 years) • Annual FOBT (fecal occult blood test) and sigmoidoscopy (every 5y – ACS) • Double contrast barium enema (every 5 yr) • Colonoscopy (every 10 years) |
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Term
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Definition
| Cigarette smoking/sedentary lifestyle/obesity Lifestyle modifications Hypertension (BP > 140/90mmHg or on antiHTN medication) (increased risk) Low HDL cholesterol (<40mg/dl) Diabetes Mellitus Increased prevalence of lipid abnormalities Postmenopausal women w/ Type 2 DM 3xs more likely to develop CVD/stroke & 4xs more likely to die from MI |
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Term
| Testing for DM in asymptomatic adults |
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Definition
| Begin testing at 45 y.o. for all Test younger if BMI >24kg/m2 & have one or more of the following factors: Sedentary lifestyle Family hx High risk heritage (ie: native American, Hispanic) Hx of gestational DM or delivery of baby >9lbs HTN (>140/90) Dyslipidemia (HDL <35mg/dL; TGL >250mg/dL) Presence of polycystic ovary syndrome (PCOS) Presence of ancanthosis nigricans Hx of cardiovascular dx Previous HbA1c ≥5.7% or hx of pre-DM |
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Term
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Definition
| Rhogam given at 28 weeks and within 72 hours of delivery. |
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Term
| Folic Acid Recommendations |
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Definition
| The recommended dosage for primary prevention is 0.4 mg per day. For secondary prevention in women with a previous fetus or child with a neural tube defect, the dosage is 4 mg per day |
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Term
| Gestation Diabetes Screening |
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Definition
| recommend that all pregnant women be screened for gestational diabetes at 24 to 28 weeks' gestation, |
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Term
| When would a clinician be concerned if lactation has not occurred in a new mother? |
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Definition
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Term
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Definition
• Maternal pain
• Trauma to the breast or nipple tissue
• Infant’s nose touching the breast
• Frequent moving of the infant’s head
• Indentation of the infant’s cheeks
• Infant’s lips are not flanged |
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Term
| What would be appropriate teaching for a breastfeeding mother in regards to bowel movements in the infant? |
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Definition
| Colostrum is a natural laxative that helps the infant pass the first stool. Meconium is the first stool after birth. This stool is black, thick and tarry. Within 2-3 days the stools will look greenish in color and within 4-5 days after birth the stool should be yellow or golden in color as in the image below. These stools will appear "seedy" in texture. There may be small bowel movements after each feed or 1-2 large bowel movements in 24 hours. |
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Term
| What are the 3 criteria for LAM? Lactational Amenorrhea Method. |
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Definition
1. Less than 6 months postpartum
2. Amenorrhea
3. Exclusively breastfeeding |
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Term
| What are the best choice BC methods in lactating women? |
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Definition
| Barrier methods, IUDs and Progestin only |
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Term
| A breastfeeding mother comes into the clinic reporting redness, swelling and severe pain to left breast with flu-like symptoms you determine that she has Mastitis. What would you teach the mother in regards to nursing? |
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Definition
| Nurse frequently on the affected side. |
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Term
| Contraindications to breastfeeding |
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Definition
• The infant has been diagnosed with galactosemia*
• The breastfeeding mother:
- Has been infected with the human immunodeficiency virus (HIV)
- Is taking antiretroviral medications
- Has untreated, active tuberculosis infected with human T-cell lymphotropic virus (HTLV), Type I or Type II
- Is using or are dependent upon an illicit drug
- Is taking prescribed cancer chemotherapy agents, such as antimetabolites that interfere with DNA replication and cell division
- Is undergoing radiation therapies; however, such nuclear medicine therapies require only a temporary interruption in breastfeeding. |
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Term
| Conditions in which a mother can breastfeed |
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Definition
• Hepatitis B surface antigen-positive.
• Infected with Hepatitis C
• Febrile (unless related to contraindications lists in previous CDC information)
• Exposed to low-level environmental chemical agents.
• Seropositive carriers of cytomegalovirus (CMV)(not recent converters if the infant is term).
• Additionally, breastfed newborns with jaundice or hyperbilirubinemia should breastfeed often (except in atypical circumstances). |
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Term
| What may be limitations to the use of NPs in practice? |
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Definition
| insurance reimbursement issues, state law discrepancies and professional tensions. |
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Term
| What is a disadvantage of recommending CAM therapies to pts? |
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Definition
| Many herbal and biologic preparations offer promise, but they are largely unregulated by government agencies, making it problematic to recommend these and to safely guide patients on their use |
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Term
Pregnancy Sign?
Missed period, Unusual or abnormal period, Just "feeling" pregnant, Nausea and Vomiting, Changes in libido, Soreness of the Breasts
Enlargement of the Breasts, Frequent Urination, Strange Cravings, Fatigue
Montgomery's Tubercules
Skin Changes
Stretch Marks
Enlarging Uterus
Movement
Colostrum from Breasts |
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Definition
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Term
Pregnancy Sign?
Enlarged Abdomen
Change in uterine shape
Braxton Hicks Contractions
Palpation of the Baby |
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Definition
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Term
Pregnancy Sign?
Fetal Heart Tones
Ultrasound Detection
X-ray Detection |
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Definition
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Term
| Labs at first prenatal visit |
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Definition
| Lab: blood type, Rh, antibody direct coombs test, hgb, hematocrite, rubella titer, syphilis, dipstick, culture/sensitivity, pap test, Chlamydia, gonorrhea, wet mouth of vag discharge (bact vaginosis), hep B, HIV. |
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Term
| When teaching a pregnant woman things to avoid to decrease risk of Toxoplasmosis a Np would advise what? |
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Definition
| not handling kitty litter, eating well-cooked meat, wearing gloves in garden |
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Term
• Screening and dating ultrasound
• Chorionic villus sampling
• Amniocentesis |
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Definition
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Term
| Maternal serum alpha-fetoprotein (MSAFP) |
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Definition
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Term
• 1-hour glucose tolerance (as indicated)
• Repeat hemoglobin (Hgb) or hematocrit (Hct)
• Repeat antibody test and prophylactic administration of RhoGam for unsensitized Rh-negative women
• Repeat HIV testing |
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Definition
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Term
• Testing for sexually transmitted diseases as indicated
• Repeat Hgb or Hct
• Presenting part |
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Definition
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Term
• Presenting part or station
• Group B streptococci culture |
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Definition
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Term
| What is the routine screening recommendation for BV in pregnant women? |
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Definition
| No routine screening recommended |
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Term
| When should labor induction be offered to the pregnant woman? |
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Definition
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Term
| A pregnant mother comes into the clinic complaining of discoloration to her face with a dark streak moving up her abdomen, how would the NP advise this patient. |
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Definition
| These are normal variations in pregnancy and are not a cause for alarm. |
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Term
| A 34 week pregnant woman comes into the office with complaints of not being able to get a deep breath. What maneuver would the NP teach the pt to help with this symptom? |
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Definition
| Suggest that she raise arms above head and take a deep breath. |
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Term
| Risk factors for preterm labor |
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Definition
Multiple gestation
Diethylstilbestrol (DES) exposure
Hydramnios
Uterine anomaly
Cervix dilated more than 1 cm at 32 weeks’ gestation
2 second-trimester abortions, More than 2 first-trimester abortions
Previous preterm labor or delivery
Abdominal surgery during pregnancy
History of cone biopsy
Cervical shortening of less than 1 cm at 32 weeks’ gestation
Uterine irritability
Cocaine abuse
Febrile illness
Bleeding after 12 weeks’ gestation
History of pyelonephritis
Cigarette smoking—more than 10 per day |
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Term
| Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). |
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Definition
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Term
| Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. |
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Definition
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Term
| Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. |
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Definition
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Term
| There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. |
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Definition
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Term
| Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. |
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Definition
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