Medications
For women with epilepsy, chronic hypertension, psy- choses, malaria, and other diseases treated with drugs that are teratogenic to the fetus, the midwife’s pre-
conception care should include collaboration with the physician who is treating the disease regarding the risk to the fetus and whether other nonteratogenic drugs exist for treatment [13]. In addition, the possi- ble teratogenic effect of any medications taken during pregnancy is always a concern [14]. Both prescription and over-the-counter medications a woman may be taking should be evaluated for potential teratogenic effects, and the continuing need for the medication should be assessed. It is very important that women do not just stop taking medication because they are pregnant as this may negatively effect their medical or mental health [15]. Many medications are safe during pregnancy. For others, the risk/benefit ratio of med- ication use and pregnancy should be discussed prior to conception whenever possible. Therefore, a plan must be in place for use of any specific medication in the preconception period and during the early stages of organogenesis [16]. The Food and Drug Administration (FDA) has identified five labeling cat- egories for use in pregnancy (Table 5-1) that assist in determining the risk of harm from specific medica- tions. Table 5-2 identifies medications that are known teratogens that should be avoided during pregnancy.
Diabetes
When blood glucose levels are consistently elevated at the time of conception and early organogenesis, there is a significantly increased risk for develop- ment of major congenital anomalies. Therefore,
women with Type I or Type II diabetes mellitus are prime candidates for preconception counseling [17, 18]. Their plan of care should focus on achieving and maintaining good control of their glucose levels in order to reduce the incidence of congenital mal- formations and low birth weight babies. If the woman is currently diet controlled or using an oral hypoglycemic agent, she should anticipate using in- sulin during pregnancy [18]. The woman with dia- betes should have her preconception visit with a high-risk obstetrician or endocrinologist who will manage the diabetes during her pregnancy.
In addition to stabilizing blood sugar levels, the preconception period is an optimal time to have a full health assessment in order to identify any high- risk factors that may be related to diabetes. This usually includes physical assessment for diabetic retinopathy, nephropathy, coronary artery disease, and hypertension [18].
Women with a history of gestational diabetes should be informed that they are at increased risk for abnormal carbohydrate metabolism during fu- ture pregnancies. Adherence to a balanced diet and a moderate plan of exercise prior to and throughout the pregnancy may minimize the risk of gestational diabetes or at least decrease the complications [18].
Cardiac Disease
The woman with known or suspected cardiac dis- ease should be strongly counseled to plan the timing of pregnancy with a cardiologist and obstetrician.
Cardiac disease may represent a minimal risk such as with mitral valve prolapse, or may be a life- threatening risk, such as that caused by pulmonary hypertension. During the preconception period, the woman’s cardiac status must be assessed and she and her family appraised of the implications that pregnancy may carry. Risk is based on three main factors: (1) the cardiac lesion, (2) the baseline func- tional compromise, and (3) the possibility of com- plications during pregnancy [19]. For a few cardiac lesions, the risk of maternal mortality is so high that termination of the pregnancy would be recom- mended for the mother’s sake. Pulmonary hyperten- sion, dilated cardiomyopathy, Marfan’s syndrome, and any uncorrectable cardiac lesion in functional classes III or IV refractory to medical management are examples of cardiac diseases that have a serious risk of maternal mortality during pregnancy.
Certainly, advance planning to avoid pregnancy would be preferable to facing the dilemma of risking both the mother’s and the baby’s life.
For many women with cardiac disease, the pos- sibility of multiple office and hospital visits as well FDA Labeling Criteria for Drugs During
Pregnancy TABLE 5-1
A Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester, and the possibility of fetal harm appears remote.
B Animal studies do not indicate a risk to the fetus;
there are no controlled human studies, or animal stud- ies do show an adverse effect on the fetus, but well- controlled studies in pregnant women have failed to demonstrate a risk to the fetus.
C Studies have shown the drug to have animal terato- genic or embryocidal effects, but no controlled studies are available in women, or no studies are available in either animals or women.
D Positive evidence of human fetal risk exists, but bene- fits in certain situations (e.g., life-threatening situa- tions or serious diseases for which safer drugs cannot be used or are ineffective) may make use of the drug acceptable despite its risks.
X Studies in animals or humans have demonstrated fetal abnormalities, or evidence demonstrates fetal risk based on human experience, or both, and the risk clearly outweighs any possible benefit.
Medications That Have Moderate to High Teratogenicity TABLE 5-2
FDA Trimester
Generic Pregnancy When Most
Drug (Class) (Trade) Names Category Teratogenic Fetal/Infant Effects
Androgen Danazol (Danocrine) X 2nd, 3rd
Angiotensin- Captopril (Capoten) C All
converting enzyme Enalapril (Vasotec) (ACE) inhibitors
Angiotensin II Candesartan D 2nd, 3rd
receptor blockers Cilexetil (Atacand) Irbesartan (Avapro)
Antibiotics Aminoglycosides: D All
Spectinomycin Gentamicin Streptomycin
Tetracycline D
Anticoagulants Warfarin (Coumadin) X All
Anticonvulsant Carbamazepine C 1st
Phenytoin D
Trimethadione D
Valproic acid D
Anti-infective Iodine D All
Antineoplastic Aminopterin X 1st
Busulfan D 1st
Cyclophosphamide D 1st
Cytarabine D 1st
Methotrexate D All
Tamoxifen D All
Antituberculosis therapy Isoniazid C All
Rifamycin C All
Antiviral (HIV) Efavirenz (Sustiva) C All
Benzodiazepine Lorazepam (Ativan) D 3rd
Clonazepam (Klonopin) C Chlordiazepoxide (Librium) D
Oxazepam (Serax) D
Diazepam (Valium) D
Chelating agent Penicillamine D 1st
Dermatologic preparation Minoxidil C 2nd, 3rd
Hallucinogen Phencyclidine X All
Hypoglycemic agents Chlorpropamide C All
Virilization of females and ambigu- ous genitalia
Fetal hypotension syndrome, fetal kidney hypoperfusion, anuria, oligo- hydramnios, pulmonary hypoplasia Fetal and neonatal hypotension, skull hypoplasia, anuria, renal failure and death
8th nerve toxicity, discoloration of teeth, altered bone growth
Bone and teeth staining
Hypoplastic nasal bridge (1st trimester) CNS malformations (2nd trimester) Risk of bleeding (3rd trimester) Neural tube defects
Hydantoin syndrome
Congenital goiter, transient hypothy- roidism
Multiple unspecified malformations and low birth weight
Shown to have an embryocidal ef- fect in rats and rabbits when given in pregnancy; no well-controlled studies in pregnant women CNS abnormalities with chronic use Teratogenic in primate lab animals;
no well-controlled human data Neonatal dependence with chronic use
Cutis laxa, other congenital anom- alies
Newborn hirsutism
Abnormal neurologic exam, including poor suck reflex and poor feeding Prolonged neonatal hypoglycemia
as close medical scrutiny should be anticipated.
Therefore, advance planning for workplace issues, health insurance, child care for other children as well as for medical care will help to optimize the outcome of pregnancy for both mother and infant.
Genetic issues may also come into play for women with cardiac disease as some disorders may be the result of inherited heart disease [16].
Therefore, genetic counseling may be indicated as part of the preconception assessment.
Seizure Disorder
The preconception care of a woman with a seizure disorder includes detailed history taking regarding her frequency of seizures and the medications being used. This is another area where physician consul- tation is required to assess the woman’s risk for pregnancy complications and to evaluate medical therapy. The most commonly used medications for control of seizures are teratogenic to the fetus. If she has not had seizures in several years, there may be an opportunity to decrease the overall dose of med- ications, at least for the early pregnancy period.
Whenever possible, the use of a single medical ther- apy is advocated [20]. If seizures are frequent or not well controlled, however, there should be strong emphasis on seizure control prior to pregnancy as this may worsen during gestation. This is also a di- agnosis that requires detailed counseling of the par- ents-to-be regarding risks to mother and infant. In addition to evaluation of the seizure disorder, it is recommended that women with neurologic disor-
ders such as epilepsy increase their dose of folic acid to 1 mg daily [11].
Hypertension
Most women with chronic hypertension can antici- pate the birth of a normal, health baby. The pri- mary goals in the preconception period are avoiding use of ACE inhibitors and angiotensin II receptor antagonists (see Table 5-2). Women should also be educated about their risk for preeclampsia and fetal growth restriction.
Thyroid disorders
Because hyperthyroidism is known to be associated with congenital malformations, adequate treatment must be undertaken prior to conception. Similarly, hypothyroidism is associated with dwarfism and other anomalies. For both hypothyroidism and hy- perthyroidism, the goal is for the woman to be eu- thyroid prior to pregnancy. Medical consultation and follow-up is indicated in order to establish a plan for assessment of thyroid levels and potential medications during pregnancy. If a woman is taking propylthiouracil or methimazole prior to preg- nancy, medication changes are recommended as both drugs are rated as Category D (see Table 5-2).
For most women with thyroid disorders, midwifery care is quite appropriate with consultation.
Infectious Diseases
The preconception period is an ideal time to assess women for infectious diseases (see Chapters 8, 15 Medications That Have Moderate to High Teratogenicity(continued)
TABLE 5-2
FDA Trimester
Generic Pregnancy When Most
Drug (Class) (Trade) Names Category Teratogenic Fetal/Infant Effects Prostaglandin analog Misoprostol (Cytotec) X All
Retinoid, systemic Isotretinoin (Accutane) X All
Retinoid, topical Tretinoin (Retin-A) C All
Sedative Thalidomide X 1st, 2nd
Thyroid drugs Propylthiouracil D All
Methimazole D All
Embryocidal in early pregnancy; may cause preterm labor and birth CNS, cardioaortic, ear, and clefting defects; microtia, anotia, thymic aplasia, brachial arch and aortic arch abnormalities; certain congenital heart malformations
Very unlikely to attain therapeutic topical exposure to retinoids Phocomelia, limb reduction Goiter
Aplastic cutis
Source:Adapted from Reynolds, H. D. Preconception care: an integral part of primary care for women. J. Nurse-Midwifery43(6):452.
and 24). For rubella and varicella, a nonimmune lab result can easily be handled with vaccine prior to pregnancy, thereby eliminating any risk during pregnancy (and thoughout life). Toxoplasmosis and cytomegalovirus can be screened for. In this case, a positive titer, indicating previous exposure, allows for reassurance of minimal risk, and a negative titer gives the opportunity to give appropriate warnings.
Hepatitis B vaccine can be offered. HIV screening and other STD testing can also be completed. If a woman becomes pregnant within 3 months follow- ing this testing, there may not be a need to repeat the STD screens at the first prenatal visit.
For women with a history of genital herpes, counseling can be done regarding the approach to this infection during pregnancy. Women at risk for tuberculosis may be screened with PPD. If they have previously had a positive PPD, or BCG vaccine, a chest x-ray can be done if indicated.
Phenylketonuria
For a woman with phenylketonuria (PKU), the best chance of protecting her child from the effects of her disease (over 90 percent of such children exhibit mental retardation and over 70 percent exhibit mi- crocephaly) lies in going back on dietary therapy before conception and continuing on the diet throughout pregnancy [21]. Many of these women have abandoned or are not in strict compliance with their dietary plan. Nutritional assistance as well as a comprehensive medical evaluation is ad- visable.
Previous Obstetric Complications
A woman who has been pregnant before may have concerns about the potential for recurrence of com- plications associated with a previous pregnancy. The best predictor for preterm birth is a previous preterm birth. Other risk factors that may repeat in subsequent pregnancies include gestational diabetes, hypertensive disorders, placenta previa, dysfunc- tional labor, and low birth weight. Complications such as an incompetent cervix, large uterine fibroids, or a previous eclampsia may indicate a need to plan for appropriate intervention in another pregnancy to help ensure the best outcome.
In addition to medical/obstetric risk factors, women may have concerns from previous birth ex- periences regarding vaginal versus cesarean birth, use of analgesia, positions for giving birth, support of care providers, and many other issues regarding the birthing process. It is important to question the woman and help her determine if there are ways to
increase her satisfaction with the birth process.
Conversely, she may have had an excellent experi- ence and want assistance in ensuring a similarly positive outcome in future pregnancies.
Advanced Maternal Age
A woman who has delayed childbearing or who is having additional children after age 35 may have age-related concerns. The preconception period is the best time to answer questions and address con- cerns. The issues after age 35 certainly include an increased risk of genetic disorders [22]. In addition, as women age, their risk for gestational diabetes, hypertension, and other chronic diseases increases.
Therefore, genetic counseling and a comprehensive medical assessment are important.
For the woman planning her first pregnancy after the age of 35, infertility may be a greater con- cern. Major changes in an established lifestyle also occur for couples of advanced age, a topic that may need to be addressed by the midwife.