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Table 2 Obstetric outcomes per study arm for HSV-2 positive pregnant participants in Mulago Hospital between January 2014 and February 2015

From: Effect of suppressive acyclovir administered to HSV-2 positive mothers from week 28 to 36 weeks of pregnancy on adverse obstetric outcomes: a double-blind randomised placebo-controlled trial

Obstetric out comes

Acyclovir

N =100(%)

Placebo

N =100(%)

Relative Risk (RR) (95%CI)

P values

Total

 PROM by 36 weeks

  No

96 (96.0)

90 (90.0)

  

  Occurred

4 (4.0)

10 (10.0)

0.35 (0.11–1.10)

0.073

 Preterm delivery (<37 weeks)a

  No

88 (88.9)

75 (76.5)

  

  Occurred

11 (11.1)

23 (23.5)

0.41 (0.20–0.85)

0.016

 Low birth weighta

  No

91 (92.0)

83 (85.0)

  

  Yes

8 (8.0)

15 (15.0)

0.43 (0.18–1.02)

0.056

 Admission in special care unita

  No

90 (91.0)

81 (82.7)

  

  Yes

9 (9.0)

17 (17.3)

0.43 (0.19–0.96)

0.040

 Evidence of shedding at termb

  No

70 (89.7)

73 (88.0)

  

  Occurred

8 (10.3)

10 (12.0)

0.55 (0.22–1.42)

0.215

  1. All the 200 participants had PROM by 36 weeks assessed. Ninety-nine and ninety-eight participants in the acyclovir arm and placebo arms respectively had the delivery outcomes assessed. We were unable to trace the outcomes for the 3 remaining participants. Thirty-nine participants missed the 38 week visit (17 in the placebo and 22 in the acyclovir arm) and delivered elsewhere. As stated above, we were able to get delivery outcomes for all except three. Unfortunately, we were unable to have cervical swabs taken at delivery for those 39 participants and thus had no results for genital shedding for them. Acyclovir between 28 and 36 weeks did not reduce the incidence of preterm PROM by 36 weeks HSV-2 shedding by delivery time and low birth. However, acyclovir administered between 28 and 36 weeks reduced the incidence of preterm delivery and admission to special care unit
  2. aHere the numbers do not add up to 100; Acyclovir arm has 99 and placebo arm 98
  3. bHere the numbers do not add up to 100; Acyclovir arm has 78 and placebo arm 83