Selected hematologic and biochemical measurements in African HIV-infected and uninfected pregnant women and their infants: the HIV Prevention Trials Network 024 protocol

BMC Pediatr. 2009 Aug 7:9:49. doi: 10.1186/1471-2431-9-49.

Abstract

Background: Reference values for hematological and biochemical assays in pregnant women and in newborn infants are based primarily on Caucasian populations. Normative data are limited for populations in sub-Saharan Africa, especially comparing women with and without HIV infection, and comparing infants with and without HIV infection or HIV exposure.

Methods: We determined HIV status and selected hematological and biochemical measurements in women at 20-24 weeks and at 36 weeks gestation, and in infants at birth and 4-6 weeks of age. All were recruited within a randomized clinical trial of antibiotics to prevent chorioamnionitis-associated mother-to-child transmission of HIV (HPTN024). We report nearly complete laboratory data on 2,292 HIV-infected and 367 HIV-uninfected pregnant African women who were representative of the public clinics from which the women were recruited. Nearly all the HIV-infected mothers received nevirapine prophylaxis at the time of labor, as did their infants after birth (always within 72 hours of birth, but typically within just a few hours at the four study sites in Malawi (2 sites), Tanzania, and Zambia.

Results: HIV-infected pregnant women had lower red blood cell counts, hemoglobin, hematocrit, and white blood cell counts than HIV-uninfected women. Platelet and monocyte counts were higher among HIV-infected women at both time points. At the 4-6-week visit, HIV-infected infants had lower hemoglobin, hematocrit and white blood cell counts than uninfected infants. Platelet counts were lower in HIV-infected infants than HIV-uninfected infants, both at birth and at 4-6 weeks of age. At 4-6 weeks, HIV-infected infants had higher alanine aminotransferase measures than uninfected infants.

Conclusion: Normative data in pregnant African women and their newborn infants are needed to guide the large-scale HIV care and treatment programs being scaled up throughout the continent. These laboratory measures will help interpret clinical data and assist in patient monitoring in a sub-Saharan Africa context.

Trial registration: ClinicalTrials.gov NCT00021671.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents / therapeutic use*
  • Blood Cell Count
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Gestational Age
  • HIV / genetics
  • HIV Infections / blood*
  • HIV Infections / epidemiology
  • HIV Infections / prevention & control
  • Hematocrit
  • Hemoglobins / metabolism*
  • Humans
  • Incidence
  • Infant
  • Infant, Newborn
  • Malawi / epidemiology
  • Nevirapine / therapeutic use*
  • Pregnancy
  • Pregnancy Complications, Infectious / blood
  • Pregnancy Complications, Infectious / prevention & control*
  • RNA, Viral / analysis
  • Retrospective Studies
  • Tanzania / epidemiology
  • Treatment Outcome
  • Young Adult
  • Zambia / epidemiology

Substances

  • Anti-HIV Agents
  • Hemoglobins
  • RNA, Viral
  • Nevirapine

Associated data

  • ClinicalTrials.gov/NCT00021671