A survey of zidovudine use in pregnant women with human immunodeficiency virus infection

Rhoda S. Sperling, Pamela Stratton, Mary Jo O'Sullivan, Pamela Boyer, D. Heather Watts, John S. Lambert, Hunter Hammill, Elizabeth G. Livingston, D. Jay Gloeb, Howard Minkoff, Harold E. Fox

Research output: Contribution to journalArticle

Abstract

Background and Methods. The expanding indications for zidovudine treatment make it important to elucidate the safety and toxicity of this drug for pregnant women and their fetuses. We asked pediatricians and obstetricians at the AIDS (acquired immunodeficiency syndrome) Clinical Trials Units to report information about pregnant women infected with the human immunodeficiency virus who were continuing their pregnancies and had received, or were receiving, zidovudine during gestation. Results. Reports of 43 women were received from 17 institutions. Doses of zidovudine ranged from 300 to 1200 mg per day, and 24 women took the drug for at least two trimesters. There were two reported instances of maternal toxicity (one gastrointestinal and one hematologic). No teratogenic abnormalities occurred in the 12 infants with first-trimester exposure to zidovudine. All the infants, including two sets of twins, were born alive. The 38 singleton infants born at term for whom birth weights were reported had a mean birth weight of 3287±670 g; two cases of intrauterine growth retardation were reported among the infants delivered at term. Hemoglobin values, which were available for 31 newborns, ranged from 7.0 to 12.4 mmol per liter (11.2 to 20 g per deciliter); 3 of the 7 newborns with hemoglobin values of less than 8.4 mmol per liter (13.5 g per deciliter) were born prematurely. Conclusions. Zidovudine was well tolerated by the pregnant women and was apparently not associated with malformations in the newborns, premature birth, or fetal distress. No pattern of hematologic toxicity was observed in the newborns, but the anemia and growth retardation seen in a minority of the infants could, in part, have resulted from their mothers' treatment with zidovudine.

Original languageEnglish (US)
Pages (from-to)857-861
Number of pages5
JournalNew England Journal of Medicine
Volume326
Issue number13
StatePublished - Mar 26 1992
Externally publishedYes

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Zidovudine
Virus Diseases
Pregnant Women
HIV
Newborn Infant
Birth Weight
Hemoglobins
Mothers
Term Birth
Pregnancy
Fetal Distress
Fetal Growth Retardation
Premature Birth
First Pregnancy Trimester
Drug-Related Side Effects and Adverse Reactions
Surveys and Questionnaires
Anemia
Acquired Immunodeficiency Syndrome
Fetus
Clinical Trials

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Sperling, R. S., Stratton, P., O'Sullivan, M. J., Boyer, P., Watts, D. H., Lambert, J. S., ... Fox, H. E. (1992). A survey of zidovudine use in pregnant women with human immunodeficiency virus infection. New England Journal of Medicine, 326(13), 857-861.

A survey of zidovudine use in pregnant women with human immunodeficiency virus infection. / Sperling, Rhoda S.; Stratton, Pamela; O'Sullivan, Mary Jo; Boyer, Pamela; Watts, D. Heather; Lambert, John S.; Hammill, Hunter; Livingston, Elizabeth G.; Gloeb, D. Jay; Minkoff, Howard; Fox, Harold E.

In: New England Journal of Medicine, Vol. 326, No. 13, 26.03.1992, p. 857-861.

Research output: Contribution to journalArticle

Sperling, RS, Stratton, P, O'Sullivan, MJ, Boyer, P, Watts, DH, Lambert, JS, Hammill, H, Livingston, EG, Gloeb, DJ, Minkoff, H & Fox, HE 1992, 'A survey of zidovudine use in pregnant women with human immunodeficiency virus infection', New England Journal of Medicine, vol. 326, no. 13, pp. 857-861.
Sperling RS, Stratton P, O'Sullivan MJ, Boyer P, Watts DH, Lambert JS et al. A survey of zidovudine use in pregnant women with human immunodeficiency virus infection. New England Journal of Medicine. 1992 Mar 26;326(13):857-861.
Sperling, Rhoda S. ; Stratton, Pamela ; O'Sullivan, Mary Jo ; Boyer, Pamela ; Watts, D. Heather ; Lambert, John S. ; Hammill, Hunter ; Livingston, Elizabeth G. ; Gloeb, D. Jay ; Minkoff, Howard ; Fox, Harold E. / A survey of zidovudine use in pregnant women with human immunodeficiency virus infection. In: New England Journal of Medicine. 1992 ; Vol. 326, No. 13. pp. 857-861.
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AU - Watts, D. Heather

AU - Lambert, John S.

AU - Hammill, Hunter

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AU - Fox, Harold E.

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N2 - Background and Methods. The expanding indications for zidovudine treatment make it important to elucidate the safety and toxicity of this drug for pregnant women and their fetuses. We asked pediatricians and obstetricians at the AIDS (acquired immunodeficiency syndrome) Clinical Trials Units to report information about pregnant women infected with the human immunodeficiency virus who were continuing their pregnancies and had received, or were receiving, zidovudine during gestation. Results. Reports of 43 women were received from 17 institutions. Doses of zidovudine ranged from 300 to 1200 mg per day, and 24 women took the drug for at least two trimesters. There were two reported instances of maternal toxicity (one gastrointestinal and one hematologic). No teratogenic abnormalities occurred in the 12 infants with first-trimester exposure to zidovudine. All the infants, including two sets of twins, were born alive. The 38 singleton infants born at term for whom birth weights were reported had a mean birth weight of 3287±670 g; two cases of intrauterine growth retardation were reported among the infants delivered at term. Hemoglobin values, which were available for 31 newborns, ranged from 7.0 to 12.4 mmol per liter (11.2 to 20 g per deciliter); 3 of the 7 newborns with hemoglobin values of less than 8.4 mmol per liter (13.5 g per deciliter) were born prematurely. Conclusions. Zidovudine was well tolerated by the pregnant women and was apparently not associated with malformations in the newborns, premature birth, or fetal distress. No pattern of hematologic toxicity was observed in the newborns, but the anemia and growth retardation seen in a minority of the infants could, in part, have resulted from their mothers' treatment with zidovudine.

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