Teratogenesis, Pregnancy and Postpartum Issues Exam 3 Flashcards
Pre-embryonic stage teratogenic effects
- 0-14 days after fertilization
- exposure to a teratogen during this time usually produces an all or nothing effect.
Embryonic stage teratogenic effects
- 14 – 56 days after fertilization and period when organogenesis occurs.
- the embryo is most susceptible to the effects of teratogens.
- exposure may result in major structural anomalies.
Fetal stage teratogenic effects
- 57 days post-fertilization until term. Histogenesis and functional maturation occur.
- minor structural changes are possible during this time, but anomalies are more likely to involve growth and functional aspects.
Pregnancy Risk Categories: A
- Controlled studies show no risk.
- Adequate, well-controlled studies in pregnant women fail to demonstrate risk.
Pregnancy Risk Categories: B
- No evidence of risk in humans.
- Either animal-reproduction studies have not shown a fetal risk but there are no controlled studies in pregnant women OR animal reproduction studies have shown risk that was not confirmed in well-controlled
Pregnancy Risk Categories: C
- Risk cannot be ruled out.
- Either animal studies have shown harm to fetus and there are no controlled studies in women OR no human or animal studies are available.
Pregnancy Risk Categories: D
- Positive evidence of risk.
- Positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk.
Pregnancy Risk Categories: X
- Contraindicated in pregnancy.
- Studies in animals or humans have demonstrated fetal abnormalities, OR there is evidence of fetal risk based on human experience OR both
- the risk of use of the drug in pregnant women clearly outweighs any possible benefit.
System for Thalidomide Education and Prescribing Safety (STEPS)
- Mandatory risk management program to reduce risk of pregnancy in those taking thalidomide
- Registration of all prescribers, patients, and pharmacies who prescribe, receive, and dispense thalidomide
- Patients must sign informed consent and complete a telephone survey
- Prescription must be filled within 7 days of the date written and no more than a 4-week supply can be dispensed at one time
- All patients are required to use contraceptive measures. Men must wear condoms because thalidomide may be present in sperm.
- Females must have a negative pregnancy test within 24 hours prior to starting therapy and monthly during treatment
iPLEDGE Program
- Mandatory computer-based risk management program for all isotretinoin products
- Requires all patients, prescribers, pharmacists, and wholesale distributors to register
- Patients must complete informed consent, pick up within (30 days for men and women who cannot get pregnant; 7 days for women of childbearing potential), not donate blood for one month after discontinuing, and not share medication with anyone
- Females of childbearing potential must have 2 negative preg tests before starting, negative preg test every month during treatment, receive counseling every month, use 2 forms of contraception, and fill prescription within 7 days of office visit
- Pharmacy must register with iPLEDGE, receive authorization from iPLEDGE for each prescription prior dispensing, write on prescription bag “Do not dispense after (expiration date)”, give medication guide with each prescription, and dispense only a 30day supply
What is the prenatal recommendation for multivitamin?
- should be taken daily
* to ensure proper nutritional requirements for fetal growth
What is the prenatal recommendation for iron?
- Requirements increase during pregnancy
* 27 mg/day
What can happen without sufficient amount of iron?
- anemia during infancy
- spontaneous abortion
- premature delivery
- delivery of a low-birth weight infant
What kind of supplements should a patient be on during pregnancy?
- multivitamin
- iron
- foalte
- calcium
- VitD
What is the prenatal recommendation for folate?
- all women of childbearing age should consume 0.4-0.9 mg of folic acid daily
- during pregnancy: recommendation is 0.6 mg/day
What can happen without sufficient amount of folate?
infant neural tube defects (NTDs)
What is the prenatal recommendation for Calcium / VitD?
1000 mg of calcium and 600 IU of vitamin D daily
What can happen without sufficient amount of calcium?
increase risk of hypertensive complications, including pre-eclampsia
What can happen without sufficient amount of calcium and vitD?
improper fetal skeletal development and organization
What are nonpharmacologic actions that a pt can take to decrease N/V?
- Eating small, frequent, bland meals; keep stomach from completely emptying
- Eating light snacks 15-20 minutes before getting out of bed
- Avoid fatty and spicy foods
- Foods higher in protein have been found to be helpful
- Rest
- Avoid sensory stimuli that aggravate N/V
- Accupuncture
Pharmacological considerations in pregnant women with N/V
- Because of teratogenicity, drugs used during 1st trimester should be restricted to those of major importance to life and health
- Complete suppression of symptoms typically not achieved with oral therapy
- Pyridoxine ± doxylamine is treatment of choice (after lifestyle) per American College of Obstetricians and Gynecologists (ACOG)
What are prescription pharmacologic actions that a pt can take to decrease N/V?
- Pyridoxine 10mg / Doxylamine 10mg (Diclegis)
- Ondansetron
- Metoclopramide
- Prochlorperazine
- Promethazine
What are non-prescription pharmacologic actions that a pt can take to decrease N/V?
- Diphenhydramine
- Doxylamine
- Ginger
- Meclizine (Dramamine)
- Pyridoxine (vit B6)
Pharmacological considerations in pregnant women with pain
- OTC APAP (B) is preferred
- avoid NSAIDs (C)
- opioids are not recommended
Pharmacological considerations in pregnant women with constipation
- All OTC and category C
- Bulk laxatives (psyllium) – first-line drug therapy option
- Stool softeners (Docusate) - first-line drug therapy option
- Osmotic laxative (polyethylene glycol) - first-line drug therapy option
- Stimulant laxative (Senna) – for occasional use only
- Avoid castor and mineral oil
Nonpharmacological considerations in pregnant women with constipation
Lifestyle and dietary changes (e.g., increase water and dietary fiber intake, moderate exercise)
Nonpharmacological considerations in pregnant women with GERD
- Eat small, frequent meals
- Avoid tobacco and alcohol
- Avoid food close to bedtime
- Elevate head of bed
- Avoid foods and beverages that can trigger symptoms
Pharmacological considerations in pregnant women with GERD
- Antacids (OTC): Aluminum, calcium, magnesium antacid, calcium carbonate is antacid drug of choice
- Sucralfate (Rx)
- H2 receptor antagonists: ranitidine, cimetidine, famotidine
- metoclopramide
- Proton pump inhibitors
Pharmacological considerations in pregnant women with VTE
- Heparin
- Enoxaparin (LMWH)
Chronic hypertension
- BP ≥ 140/90 prior to pregnancy or before 20 weeks gestation
- Hypertension that is diagnosed for the 1st time during pregnancy and persists ≥ 12 weeks postpartum
Gestational hypertension
- Hypertension without proteinuria occurring after 20 weeks gestation
- Transient if preeclampsia is not present at time of delivery and does not last > 12 weeks
Preeclampsia
- BP ≥ 140/90 after 20 weeks gestation in a women with previously normal BPs and with proteinuria (>300 mg/24 hours or protein/creatinine ratio ≥ 3).
- Can progress to eclampsia (seizures)
Chronic hypertension with superimposed preeclampsia
- New onset proteinuria after 20 weeks in a woman with chronic hypertension
- In a woman with hypertension and proteinuria prior to 20 weeks gestation any of the following are seen: Sudden 2-3 fold increase in proteinuria, Sudden increase in BP, Thrombocytopenia (platelets < 100,000 cells/mm3), Increase in liver enzymes (ALT/AST)
When should HTN be treated in a pregnant woman?
when SBP ≥ 160 or DBP ≥ 110
Treatment for Mild to Moderate Gestational and Chronic Hypertension
- mild to moderate: SBP 140-159 or DBP 90-109
- Treatment does not benefit the fetus or prevent preeclampsia
- nonpharmacologic therapy indicated
- if pt on therapy before pregnancy, decrease their dose or d/c it
Treatment for Severe Gestational and Chronic Hypertension
- severe: SBP ≥ 160 or DBP ≥ 110
- Pharmacological treatment is recommended: Methyldopa, Labetolol, Nifedipine
- Nonpharmacological: Bed rest, limited activity, salt and protein restriction, stress reduction
- ACEI/ARB are should be avoided
Management of Mild to Moderate Preeclampsia
- Measure BP twice weekly
- Obtain CBC, platelet count, liver function tests, LDH, uric acid, and creatinine weekly
- Assess for proteinuria
- Obtain a fetal non-stress test twice weekly
- Measure amniotic fluid index once or twice weekly
- Ultrasonography for fetal growth every three-four weeks
- Delivery of baby
- Bed rest
Management of Severe Preeclampsia
- BP can be managed with IV labetolol and hydralazine
- Delivery decisions will be more aggressive depending on fetal age
- Magnesium sulfate for seizure prevention
- bed rest inpt and carefully monitored
Management of Eclampsia
- Patient will be intubated to protect the airway
- Magnesium is the drug of choice for treatment of seizures
- Once the patient has stabilized from the seizure, plans will be made for delivery
Pharmacological considerations in pregnant women with asthma
- monitor asthma control monthly to ensure adequate oxygenation of the fetus
- Avoid environmental triggers
- Albuterol preferred for SABA
- Inhaled corticosteroid (ICS): Budesonide preferred unless pt is already on an ICS
- LABA is (C)
Pharmacological considerations in pregnant women with epilepsy
- try to use lowest doses use use monotherapy
- Folic acid supplementation at 4-5 mg/day
- Phenytoin
- Carbamazepine
- Valproic Acid
- Phenobarbital
- Gabapentin
- Pregabalin
- Lamotrigine
- Topiramate
- Levetiracetam
- Felbamate
- Oxcarbazepine
Pharmacological considerations in pregnant women with anxiety and depression
- SSRIs commonly used in pregnancies and considered drugs of first line
- Chlorpromazine
- haloperidol
- perphenazine
Which medications are recommended for of Tocolytic Therapy to prolong pregnancy?
- Terbutaline (Beta2-agonists)
- Magnesium Sulfate
- Nifedipine (Calcium channel blockers)
- Indomethacin (NSAIDs)
Which medications are recommended for stimulating fetal lung maturation?
- Corticosteroids
- Betamethasone
- Dexamethasone
Which medications are recommended for cervical ripening
- Prostaglandin E2 analogs (Prepidil, Cervidil)
- Prostaglandin E1 analog (Misoprostol)
Which medications are recommended for labor induction?
Oxytocin
What are the 7 drugs/classes that are contraindicated or should be avoided during lactation?
- Bromocriptine
- Chemotherapy
- Codeine
- Cyclophosphamide
- Cyclosporine
- Iodine
- Lithium carbonate
- Methotrexate
Which medications are recommended for postpartum depression?
- Sertraline – first-line
* Paroxetine and nortriptyline – second-line
