listened Comprehensive Notes on Non Self-Administered, Nonhormonal Contraception, and Pregnancy Termination
Digital Health and Contraceptive Mobile Applications
FDA Oversight of Mobile Medical Applications: * The FDA maintains oversight of software functions that meet the definition of a medical device. * The primary concern is functionality that could pose a risk to patient safety if it fails to function as intended. * Policy was last updated in September $2022$.
Natural Cycles (Cycle App): * FDA-approved for users $18$ years of age and older. * Requires an annual subscription and the use of a basal body temperature thermometer. * Efficacy Rates: * Typical Use: effective. * Perfect Use: effective. * Data Entry: Users record basal body temperature every morning. * Wearable Compatibility: NC Band, Oura Ring, Garmin Watch, and Apple Watch. * Output: Provides a daily fertility status.
Clue Birth Control (Cycle App): * Received FDA clearance in $2021$ but has not yet fully launched as of the lecture data (Clue cycle tracking app is available). * Efficacy Rates: * Typical Use: effective. * Perfect Use: effective. * Criteria for Use: Users aged $18-45$ with cycles between days in length, with a variance of $9$ days or less. * Mechanism: Uses documentation of "cycle day $1$" and does not appear to require basal body temperature monitoring.
Other Available Tracking Apps: * Ovia Health, Flo, MyFlo, MagicGirl (specifically designed for teens), Cycles, Eve by Glow, Glow, Apple Cycle Tracking, Spot On, and Period Tracker.
Lactic Acid, Citric Acid, and Potassium Bitartrate Vaginal Gel (Phexxi)
Overview: * Approved for on-demand pregnancy prevention in females of reproductive potential. * Product Content: Each single-dose ($5$ grams) pre-filled applicator contains: * of lactic acid. * of citric acid. * of potassium bitartrate. * Administration: Administer one $5$-gram dose immediately before or up to $1$ hour before each act of vaginal intercourse. * Mechanism of Action: Lowers vaginal pH to reduce sperm motility.
Efficacy and Safety: * Efficacy: Estimated Pearl Index (failures per women-years) is , which is approximately effective. * Compatibility: * Avoid use with vaginal rings. * Safe for use with condoms, diaphragms, and vaginal infection treatments. * Adverse Effects: Vaginal burning, itching, discomfort, hypersensitivity, and vaginal mycotic infections. * Serious Reports: Instances of cystitis and pyelonephritis have been reported.
Depot Medroxyprogesterone Acetate (DMPA) - Contraceptive Injection
Product Formulations: * Subcutaneous (SQ): administered every $3$ months ( weeks). * Intramuscular (IM): administered every $3$ months ($13$ weeks). * CDC call in $2021$ recommended making self-administered SQ options available.
Adverse Effects: * Menstrual Irregularities: Frequent breakthrough bleeding; of users become amenorrheic within $1$ year. * Weight Gain: Average of at $1$ year and at $5$ years. * General: Headache (), bloating, breast tenderness, mood changes, and decreased libido. * VTE Risk: Increased risk of Venous Thromboembolism () compared to Progestin-only Pills ().
Fertility Return: Delayed; median time to conception is months after the last injection (range of months).
Bone Health Warning: * Black Box Warning: Potential for decreased Bone Mineral Density (). * Loss of over $5$ years; loss increases with duration. * May not be completely reversible. * Recommendation: Not recommended for use longer than $2$ years unless necessary; supplement with Calcium and Vitamin D. * ACOG Position: Supports use $>2$ years and states measurements are not necessary, as mostly recovers (though recovery at the hip/femoral neck in adolescents is a concern).
Non-Contraceptive Benefits: * Decreased risk of endometrial cancer. * reduction in seizures for women with epilepsy. * reduction in acute sickle cell crises (caution regarding possible risk). * Improved iron-deficiency anemia due to reduced menstrual cycles. * Effective regardless of weight or drug interactions.
Initiation Protocols: * Start if "reasonably certain" not pregnant. * Within 7 days of menses start: No backup needed. * After 7 days of menses start (or amenorrhea): Use backup for $7$ days. * Postpartum: Can start any time. No backup if < $6$ months, amenorrheic, and fully breastfeeding. Otherwise, backup for $7$ days if > $21$ days postpartum.
Dosing Windows: * Early: No limit. * Late: Up to $2$ weeks late ( weeks from last dose) requires no backup. * Over $2$ weeks late ($>15$ weeks): Requires backup for $7$ days and possible emergency contraception ().
Bleeding Management: * Rule out other causes first. * Treatment: for days during bleeding; low-dose or estrogen for days for heavy bleeding.
Long-Acting Reversible Contraceptives (LARCs) - Intrauterine Devices (IUDs)
Levonorgestrel (LNG) IUDs: * Skyla: LNG; lasts $3$ years. * Kyleena: LNG; lasts $5$ years. * Mirena: LNG; lasts $8$ years. * Liletta: LNG; lasts $8$ years.
Copper IUDs (Nonhormonal): * ParaGard: Copper T; lasts $10$ years. * Miudella: Copper T; lasts $3$ years.
Mechanisms of Action (MOA): * Inhibits fertilization via thickened cervical mucus and inhibited sperm function. * Endometrium suppression and weak foreign body reaction induction. * Ovulation is generally not inhibited (most cycles are ovulatory), though Mirena may inhibit some.
Efficacy: Highly efficacious with failure rates $< 0.9\%$.
Placement and Timing: * Insert any time patient is reasonably certain not pregnant. * Copper IUD: No backup needed. * LNG IUD: Backup for first $7$ days if inserted $>7$ days since menses began. * STD Screening: Do not delay for screening unless infection is highly likely. If an STD occurs while the IUD is in place, treat the STD; IUD removal is only considered if symptoms don't resolve in hours (CDC MEC Category $2$).
Adverse Effects: * Mild bleeding/cramping ($1-2$ days); irregular breakthrough bleeding for $6$ months. * amenorrhea rate at $1$ year. * Expulsion risk: within days ; after day .
Long-Acting Reversible Contraceptives (LARCs) - Etonogestrel Implant
Nexplanon: * Etonogestrel single rod (matchstick-sized). * Implanted subdermally; effective for up to $5$ years. * Requires specific training for provider insertion and removal.
Initiation: * Within $5$ days of menses start: No backup. * After $5$ days (or amenorrhea): Backup for $7$ days. * Postpartum: Same rules as DMPA (fully breastfeeding/amenorrheic vs. $7$-day backup).
Adverse Effects: * Irregular Bleeding: Most common side effect; requires proactive counseling. * General: Headaches, acne, emotional lability, weight increase, depression, site reactions.
Bleeding Management: * Hormonal Treatment: Low-dose or estrogen ( days). * Antifibrinolytic: Tranexamic acid for $5$ days. * : days during bleeding episodes. * : Tamoxifen for days.
Emergency Contraception (EC)
Levonorgestrel (LNG) - Plan B One-Step / Next Choice: * Dose: tablet once. * Timing: Use ASAP within $5$ days (120 hours). * Efficacy: if within $72$ hours; between days $4-5$. * Repeat Dosing: Repeat if vomited within $2$ hours. * Weight Consideration: May lose efficacy in women $> 165\,lb$ and lose it completely in women $> 175\,lb$.
Ulipristal Acetate (UPA) - Ella: * Dose: tablet once ( only). * Timing: Maintains high efficacy for the full $5$ days. * Repeat Dosing: Repeat if vomited within $3$ hours. * Warning: Could harm a fetus; do not use if pregnancy from a previous act is suspected.
Copper IUD (ParaGard): * $> 99\% effective. * Can be inserted up to $5$ days after intercourse.
LNG IUD for EC: * Non-inferior to Copper IUD for EC (Research shows $1$ pregnancy in $317$ for LNG vs. $0$ in $321$ for Copper).
Mechanisms of EC: * Inhibits or delays ovulation (UPA delays for $5$ days). * Implantation inhibition is probable with UPA, improbable with LNG.
Drug Interactions: * Both are major 3A4 substrates. Strong inducers (e.g., Carbamazepine, Phenytoin, Rifampin, St. John\'s wort) decrease effectiveness. * UPA efficacy decreased by medications increasing gastric pH (PPIsH_2 blockers, antacids).
EC Follow-Up and Contraception Initiation: * Starting regular BC after LNG: Immediately. * Starting regular BC after UPA: Wait $5$ days before starting hormonal methods. * Backup required: $7$ days or abstain. * Pregnancy test if menses is $> 1$ week late or no menses in $3$ weeks.
Special Patient Populations and Contraception
Age and Menopause: * Median menopause age is 5140-60 range). * FSH tests are not accurate determinants of infertility. * Can use contraceptives until age 50-55.
Perimenopausal Considerations: * LNG IUDs help with heavy menses and protect against endometrial hyperplasia (off-label). * COCsVTE risk via the patch.
Overweight and Obese Women: * No change in efficacy for DMPA, LNG IUD, or Etonogestrel implant. * COCsBMI > 3535.
Transgender Men: * Testosterone use does not prevent pregnancy; contraceptive counseling is essential for those with a uterus.
Pregnancy Loss and Elective Termination
Definitions: * Spontaneous Abortion: Miscarriage (non-preventable). Confirmed by ultrasound (empty sac or no fetal heart activity). * Risk Factors: Increases with maternal age (17\% at age $30$; 80\% at age $45$).
Misoprostol (Prostaglandin E1 Analog): * MOA: Causes cervical softening and dilation. * Dosing for Early Loss: 800\,mcg vaginally once (repeat as needed). * Other Uses: GI ulcer prevention, IUD insertion pre-treatment (400\,mcg $2-3$ hours prior).
Mifepristone (Mifeprex - Progesterone Antagonist): * Approved for termination through $10$ weeks (70 days gestation). * REMS Program (Mod. 1/3/23): Requires certified prescribers and pharmacies. Prescriber/Patient agreement forms required. * Regimen: 200\,mg800\,mcg24-48 hours.
Safety and Warnings: * Risk of serious bacterial infection/sepsis and prolonged heavy bleeding. * Expected bleeding: 9-168\% experience $> 30$ days). * Contraindication: Ectopic pregnancy. * Side Effects: Nausea (75\%$$), weakness, fever, vomiting, headache, diarrhea, and dizziness.