Table 16 Impact of PMTCT on stillbirth and perinatal mortality

Suksomboon et al. 2007 [167]

USA, France, Côte d'Ivoire, Burkina Faso, Thailand, Bahamas, Brazil.

Meta-analysis (Cochrane). 15 trials, 5 reporting SBR.

Assessed a variety of regimens and dosing schedules for PMTCT for efficacy in preventing vertical transmission, infant death, and adverse pregnancy outcomes.

Zidovudine vs. placebo:

Vertical transmission: Pooled RR = 0.57 (95% CI: 0.45–0.71)

LBW: Pooled RR = 0.75 (95% CI: 0.57–0.99, P = 0.039)

SBR: [NS]

Pre-term: [NS]

2-dose maternal+infant nevirapine therapy vs. nevirapine placebo (both given zidovudine)[1 RCT]:

Infant death: RR = 0.20 (95% CI: 0.05–0.90)

SBR: RR = 1.11 (95% CI: 0.48–2.56) [NS]

[10/826 vs.9/835 in intervention vs. control groups, respectively (pooled)].

Volmink et al. 2007 [166]

Thailand, Côte d'Ivoire, Burkina Faso, Uganda, Kenya, USA, France, Brazil, Bahamas, Tanzania, Zimbabwe.

Meta-analysis (Cochrane). 13 RCTs included that reported stillbirth rates.

Assessed the impact of zidovudine alone (intervention #1), nevirapine alone (intervention #2), and combination zidovudine-nevirapine therapy (intervention #3) vs. placebo (controls) on MTCT. Subgroups also analyzed according to breastfeeding.

Pooled analysis not given for SBR.

ARV vs. placebo:

Vertical transmission: RR = 0.46 (95% CI: 0.35–0.60)

SBR: RR = 0.14 (95% CI: 0.02–1.17); RR = 0.33 (95% CI: 0.01–8.11); RR = 0.40 (95% CI: 0.07–2.15); RR = 0.80 (95% CI: 0.20–3.18); RR = 3.02 (95% CI: 0.12–73.57); RR = 3.50 (95% CI: 0.74–16.55) for the 6 trials, respectively.

Long vs. short-course zidovudine:

SBR: RR = 0.25, 95% CI: 0.05–1.17; RR = 0.33, 95% CI: 0.11–1.01; RR = 0.55, 95% CI: 0.23–1.33, for the 3 trials, respectively

Wiysonge et al. 2005 [173]

Tanzania, Zimbabwe, South Africa, and Malawi.

Meta-analysis (Cochrane). 4 RCTs included (N = 2855 participants).

Assessed the impact of vitamin A supplementation (intervention) vs. placebo (controls) on MTCT.

SBR: OR = 0.99 (95% CI: 0.67–1.46) [NS]

Intervention studies

Bussmann et al. 2007 [169]

Botswana.

RCT.

Assessed the impact of 6 HAART regimens, 3 of which contained efavirenz (intervention), vs. non-efavirenz regimens (controls).

SBR: No difference between efavirenz and non-efavirenz-exposed pregnancies (P = 0.7).

Sharma et al. 2007 [172]

USA (New York).

Prospective cohort study (before-after design). Women's Interagency HIV study, data collected pre-HAART (1994–95) and during HAART (2001–02).

Assessed the impact of HAART on live birth rates among HIV-positive women (intervention) compared to HIV-negative women (comparison).

Live birth rate: 150% vs. 5% higher in intervention vs. comparison groups after introduction of HAART (P = 0.001).

Sperling et al. 1996 [204]

USA.

RCT. Mother-infant pairs (N = 402).

Compared the impact of maternal zidovudine treatment (intervention) vs. placebo (controls).

Rate of HIV-1 transmission: 7.6% (95% CI: 4.3–12.3%) vs. 22.6% (95% CI: 17.0–29.0%) in intervention vs. control groups, respectively (P < 0.001).

Transmission occurred at a wide range of maternal plasma HIV-1 RNA levels.

No SBR reported.

Stiehm et al. 1999 [205]

USA, Puerto Rico.

RCT. Women (N = 501) at 53 centers.

Assessed the impact of HIV immunoglobulin 200 mg/kg IV infusion every 4 wks beginning between 20 – 30 wks gestation and during delivery plus 200 mg/kg IV infusion to baby within 12 hours of birth, plus maternal+infant zidovudine standard course (intervention)

vs. standard polyvalent HIV antibody-negative IVIG to mother and baby as above, plus maternal+infant zidovudine standard course (controls).

SBR: RR = 0.33 (95% CI: 0.01–8.03) [NS]

[0/231 vs. 1/228 in intervention vs. control groups, respectively.]

Tonwe-Gold et al. 2007 [171]

Cote d'Ivoire (Abidjan).

Observational cohort study.

Assessed the impact of HAART vs. short-course anti-retroviral (scARV) PMTCT regimens to which women were allocated according to their clinical and immunological status.

SBR: [NS]

[4 (3.9%) vs. 6 (4.3%) in HAART vs. scARV for PMTCT groups, respectively (P = 1.00)].

Townsend et al. 2007 [170]

UK, Ireland.

Retrospective study. Pregnancies in women notified to the National Study of HIV in Pregnancy and Childhood (NSHPC).

Compared women on HAART (intervention) to women on mono/dual therapy (controls).

SBR: adj. OR = 2.27 (95% CI: 0.96–5.41; P = 0.063) [NS]

[12.7/1000 births (43/3384) vs. 5.7/1000 (6/1061) in HAART vs. mono/dual therapy groups].

Tuomala et al. 2002 [168]

USA (Miami, Florida & Southern California).

Case control study. 2 multisite studies + 3 single site studies.

Compared impact of combination ART (cases) vs. no ART (controls)

SBR: 12/2123 (1%) vs.7/1143 (1%) in intervention vs. control groups, respectively. Adjusted rate (for CD4, tobacco, alcohol, illicit drug use): 1% (P = 0.92) [NS]

Onah et al. 2007 [206]

Nigeria (Enugu).

Retrospective case-control study. Pregnant women (N = 162; N = 62 HIV-positive women, N = 100 HIV-negative controls) delivering in the University of Nigeria Teaching Hospital from 2002–2004.

Compared incidence of stillbirth in untreated HIV-positive women (cases) vs. HIV-negative women (controls).

SBR: No difference (P > 0.05).

4.8/1000 vs. 1.0/1000 in cases vs. controls, respectively.

Maternal and fetal morbidities: higher in HIV-positive group.