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Detecting congenital malformations - Lessons learned from the Mpepu study, Botswana.

Gbolahan Ajibola1, Rebecca Zash1,2,3, Roger L Shapiro1,3

  • 1Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.

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|March 25, 2017
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Summary

Monitoring congenital malformations in infants born to HIV-infected women on antiretroviral treatment (ART) is crucial. This study highlights the need for enhanced surveillance and geneticist involvement to ensure ART safety during pregnancy.

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Area of Science:

  • Obstetrics and Gynecology
  • Pediatrics
  • Infectious Diseases

Background:

  • Increasing numbers of HIV-infected women are conceiving while on antiretroviral treatment (ART).
  • While most ARTs are considered safe in pregnancy, monitoring for rare adverse outcomes in infants is necessary.
  • Resource-limited settings often lack robust surveillance systems for monitoring ART safety during pregnancy.

Purpose of the Study:

  • To describe congenital malformations identified in infants born to HIV-infected women receiving ART in Botswana.
  • To evaluate the effectiveness of current malformation identification and classification processes.
  • To highlight opportunities for strengthening congenital malformation surveillance in resource-limited settings.

Main Methods:

  • Retrospective secondary analysis of data from the Mpepu Study (ClinicalTrials.gov NCT01229761) in Botswana.
  • Infants were examined at birth and every 3 months up to 18 months; malformations were documented.
  • A geneticist classified malformations, distinguishing between major and minor structural abnormalities.

Main Results:

  • 2,971 live-born infants were included; 1,088 (38%) mothers were on ART at conception, and 1,147 (40%) started ART during pregnancy.
  • Of 33 reported anomalies, 25 (76%) met congenital malformation criteria.
  • 10 (30%) were classified as major malformations, with 4 identified after the initial newborn exam.

Conclusions:

  • Enhanced staff training for malformation identification is essential.
  • Programmatic monitoring should extend beyond the birth examination.
  • Geneticist involvement is valuable for accurate malformation classification, particularly in resource-limited settings to ensure ART safety in pregnancy.