Page 364 - SAHCS HIVMed Journal Vol 20 No 1 2019

Page 3 of 12 Original Research

chromosomal tests, and the assessment of the clinician at As these outcomes could be linked to a broader range of
the time of the event. The panel classified CMs as major exposure timings than just T1, we compared any ART exposure
(i.e. structural changes that have significant medical, social during pregnancy to a comparator group with no HIV/ART
or cosmetic consequences for the affected individual, and exposure (i.e. HIV-uninfected women).
typically require medical intervention), or minor, and advised
on inclusion in the risk factor analyses. We were guided by Exclusions from analyses
the example of Holmes; in that single minor anomalies, Maternal deaths whose medical records were not accessible
31
normal variations, birth marks, chromosomal or genetic for review or where there was no delivery of a foetus
anomalies/disorders, positional deformities, features of were excluded from the analysis. Maternal deaths are
prematurity and physiological abnormalities were excluded systematically reviewed for causes through other national
from the analysis of teratogenic potential.
procedures. A central register of deliveries housed at the
1
hospital was used to establish the rate of capture of deliveries
Neonates born in surrounding clinics or other health facilities
but admitted to PMMH were not included in this analysis. through the surveillance system. Women who switched from
Babies born at home, in the community or en-route to the a NVP-based regimen to an EFV-based regimen or vice
PMMH who were brought directly to the hospital without versa, were excluded from all drug-specific and time-period-
first attending any other health facility were included. CMs specific (‘entire first trimester’ vs. ‘any part of pregnancy’)
diagnosed after discharge were not identified or reported in analyses. Pregnancies were excluded from all risk analyses
this analysis. (though not from the overall demographic and ART exposure
breakdown) if:
Miscarriages and terminations of pregnancy (TOPs) were not • HIV status was unknown.
systematically captured, as they are not managed in the • HIV status was recorded as positive but there was no
maternity wards. Complicated congenital anomalies detected record of ART (as this constitutes sub-standard care in the
on ultrasound may sometimes have been referred to Inkosi local context and is associated with substantially worse
Albert Luthuli Central Hospital and delivered there, outcomes).
especially if neonatal surgery was anticipated. Early medical • Birth outcomes were unknown (alive or dead).
or curettage-based TOPs that did not require foeticide of the • Multiple births were recorded (as multiple births are
baby (i.e. before 24 weeks gestational age or a lethal foetal known to have higher complication rates and higher rates
anomaly) would have been conducted at PMMH but might of CMs).
not have been captured in the maternity registers depending
on the gestation. Figure 1 below provides a breakdown of the cohort of
pregnant women (deliveries) and their birth outcomes
A concurrent prospective pregnancy exposure registry project primarily by HIV exposure and ART exposure.
involving the recruitment of pregnant women at their first
antenatal visit was implemented at 3 midwife-run obstetric Antiretroviral therapy exposures
units (MOUs) within the PMMH catchment area. However,
as the data for this cohort were not available at the time of the The present analysis is based on 1 year of data from an
analysis, we are unable to report on this prospective cohort. ongoing surveillance system – approximately 18 months
after first-line therapy was being changed from TDF/
Risk analyses lamivudine (3TC)/NVP to TDF/emtricitabine (FTC)/EFV.
Exposures to (second-line) PIs, as well as non-standard
We conducted two separate risk analyses for ART exposure: regimens, were limited. Given the a priori concern about non-
• Analysis A (see 2.3.4.): Risk factors for major CM detected nucleoside reverse transcriptase inhibitors (NNRTIs), risk
at birth. As the critical exposures are likely to be during factor analysis was confined to assessing the effects of (1) any
organogenesis (T1), we compared exposure ‘during the ART regimen, (2) EFV-based regimens and (3) NVP-based
entire first trimester’ with no exposure during any part of regimens.
the first trimester. Women for whom the timing of ART
was uncertain in relation to the first trimester were To verify the timings of exposures reported in the MCR,
excluded from this analysis. women were also explicitly asked, after delivery, whether
• Analysis B (see 2.3.5.): Risk factors for a composite of ART had been initiated ‘before’ or ‘during’ the pregnancy.
other ABOs, which included:
ß Pregnancy losses: Birth of a dead foetus. Risk analysis A – Major congenital malformations
ß Neonatal deaths (included deaths before 28 days post- detected at birth
delivery which occurred prior to hospital discharge). For consideration of major CM, risk factor timing is critical
ß Small for gestational age (live births with birth weight because the period of pregnancy when maternal drug
below the 10th percentile using WHO criteria). exposure has the greatest teratogenic potential is the
ß Preterm delivery (live births born at gestational age less embryonic phase during which organ differentiation is
than 37 weeks). completed. In addition, this analysis of 1 year of data was
ß Low birth weight (live births born at weight < 2500 g) not adequately powered to conduct finely differentiated

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