Recommendations For the Monitoring of Women and Their Infants

Pregnant Woman and Fetus
HIV-1-infected pregnant women should be monitored according to the same stand-ards for monitoring HIV-infected persons who are not pregnant. This monitoring should include measurement of CD4+ T-lymphocyte counts and HIV-1 RNA levels approximately every trimester (i.e., every three to four months) to determine a) the need for antiretroviral therapy of maternal HIV-1 disease, b) whether such therapy should be altered, and c) whether prophylaxis against Pneumocystis carinii pneumonia should be initiated. Changes in absolute CD4+ count during pregnancy may reflect the physiologic changes of pregnancy on hemodynamic parameters and blood volume as opposed to a long-term influence of pregnancy on CD4+ count; CD4+ percentage is likely more stable and may be a more accurate reflection of immune status during pregnancy (158, 159). Long-range plans should be developed with the woman regarding continuity of medical care and antiretroviral therapy for her own health after the birth of her infant.

Monitoring for potential complications of the administration of antiretrovirals during pregnancy should be based on what is known about the side effects of the drugs the woman is receiving. For example, routine hematologic and liver enzyme monitoring is recommended for women receiving ZDV, and women receiving protease inhibitors should be monitored for the development of hyperglycemia. Because combination antiretroviral regimens have been used less extensively during pregnancy, more intensive monitoring may be warranted for women receiving drugs other than or in addition to ZDV.

Antepartum fetal monitoring for women who receive only ZDV chemoprophylaxis should be performed as clinically indicated, because data do not indicate that ZDV use in pregnancy is associated with increased risk for fetal complications. Less is known about the effect of combination antiretroviral therapy on the fetus during pregnancy. Thus, more intensive fetal monitoring should be considered for mothers receiving such therapy, including assessment of fetal anatomy with a level II ultrasound and continued assessment of fetal growth and well being during the third trimester.

Neonate
A complete blood count and differential should be performed on the newborn as a baseline evaluation before administration of ZDV. Anemia has been the primary complication of the 6-week ZDV regimen in the neonate; thus, repeat measurement of hemoglobin is required at a minimum after the completion of the 6-week ZDV regimen. Repeat measurement should be performed at 12 weeks of age, by which time any ZDV-related hematologic toxicity should be resolved. Infants who have anemia at birth or who are born prematurely warrant more intensive monitoring.

Data are limited concerning potential toxicities in infants whose mothers have received combination antiretroviral therapy. More intensive monitoring of hematologic and serum chemistry measurements during the first few weeks of life is advised in these infants. However, it should be noted that the clinical relevance of lactate levels in the neonatal period to assess potential for mitochondrial toxicity has not been adequately evaluated.

To prevent P. carinii pneumonia, all infants born to women with HIV infection should begin prophylaxis at 6 weeks of age, following completion of the ZDV prophylaxis regimen (160). Monitoring and diagnostic evaluation of HIV-1-exposed infants should follow current standards of care (161). Data do not indicate any delay in HIV-1 diagnosis in infants who have received the ZDV regimen (1,162). However, the effect of combination antiretroviral therapy in the mother and/or newborn on the sensitivity of infant virologic diagnostic testing is unknown. Infants with negative virologic tests during the first 6 weeks of life should have diagnostic evaluation repeated after completion of the neonatal antiretroviral prophylaxis regimen.

Postpartum Follow-Up of Women
Comprehensive care and support services are required for women with HIV infection and their families. Components of comprehensive care include the following medical and supportive

• Primary, obstetric, pediatric and HIV specialty care;
• Family planning services;
• Mental health services;
• Substance-abuse treatment; and
• Coordination of care through case management for the woman, her children, and other family members.

Support services may include case management, childcare, respite care, assistance with basic life needs (e.g., housing, food, and transportation), and legal and advocacy services. This care should begin before pregnancy and should be continued throughout pregnancy and postpartum.

Maternal medical services during the postpartum period must be coordinated between Obstetric Care Providers and HIV specialists. Continuity of antiretroviral treatment when such treatment is required for the woman's HIV infection is especially critical and must be ensured. Concerns havebeen raised about adherence to antiretrovirals during the post-partum period. Women should be counseled that the physical changes of the postpartum period, as well as the stresses and demands of caring for a new baby, may make adherence more difficult and additional support may be needed to maintain good adherence to their therapeutic antiretroviral regimen during this period (163, 164). The health care provider should be vigilant for signs of depression, which may require assessment and treatment and which may interfere with adherence. Poor adherence has been shown to be associated with decreased viral control, development of resistance, and decreased long-term effectiveness (165-170) The efforts to keep good adherence during the postpartum period might prolong the effectiveness of therapy. See the Adherence section in the Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents, available at the HIV/AIDS Treatment Information Service (ATIS) website (http://www.hivatis.org).

All women should receive comprehensive health-care services that continue after pregnancy for their own medical care and for assistance with family planning and contraception. In addition, this is also a good time to review immunization status and update vaccines, assess the need for prophylaxis against opportunistic infections, and re-emphasize safer sex practices.

Data from PACTG Protocols 076 and 288 do not indicate adverse effects through 18 months postpartum among women who received ZDV during pregnancy; however, continued clinical, immunologic, and virologic follow-up of these women is ongoing. Women who have received only ZDV chemoprophylaxis during pregnancy should receive appropriate evaluation to determine the need for antiretroviral therapy during the postpartum period.

Long-Term Follow-Up of Infants

Data remain insufficient to address the effect that exposure to ZDV or other antiretroviral agents in utero might have on long-term risk for neoplasia or organ-system toxicities in children. Data from follow-up of PACTG 076 infants through age 6 years do not indicate any differences in immunologic, neurologic, and growth parameters between infants who were exposed to the ZDV regimen and those who received placebo and no malignancies have been seen (54, 55). Continued evaluation of early and late effects of in utero antiretroviral exposure is ongoing through a number of mechanisms, including a long-term follow-up study in the Pediatric AIDS Clinical Trials Group (PACTG 219C), natural history studies, and HIV/AIDS Surveillance conducted by states and the Centers for Disease Control and Prevention. Since most of the available follow-up data relate to in utero exposure to antenatal ZDV alone and most pregnant women with HIV infection currently receive combination therapy, it is critical that studies to evaluate potential adverse effects of in utero drug exposure continue to be supported in an ongoing fashion.

Innovative methods are needed to provide follow-up of infants with in utero exposure to antiretroviral drugs. Information regarding such exposure should be part of the ongoing permanent medical record of the child - particularly for uninfected children. Children with in utero antiretroviral exposure who develop significant organ system abnormalities of unknown etiology, particularly of the nervous system or heart, should be evaluated for potential mitochondrial dysfunction (41). Follow-up of children with antiretroviral exposure should continue into adulthood because of the theoretical concerns regarding potential for carcinogenicity of the nucleoside analogue antiretroviral drugs. Long-term follow-up should include yearly physical examinations of all children exposed to antiretrovirals and for adolescent females, gynecologic evaluation with pap smears.

On a population basis, HIV-1 surveillance databases from states that require HIV-1 reporting provide an opportunity to collect information concerning in utero antiretroviral exposure. To the extent permitted by federal law and regulations, data from these confidential registries can be used to compare with information from birth defect and cancer registries to identify potential adverse outcomes.

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