Skip to main content

Table 3 Trial outcomes for women randomized to clotrimazole and usual care

From: Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial

Trial outcomes

Clotrimazole

N = 50

n (%)

Usual care

N = 49*

n (%)

RR (95% CI)

Preterm birth

   

   Spontaneous/PPROM

1 (2)

3 (6)

0.33 (0.04, 3.03)

   Any preterm birth

2 (4)

3 (6)

0.65 (0.11, 3.74)

Pregnancy complications

   

   Gestational diabetes

6 (12)

5 (10)

1.18 (0.38, 3.60)

   Antepartum haemorrhage/abruption

2 (4)

4 (8)

0.49 (0.09, 2.55)

Induction of labor

Mode of delivery

16 (32)

11 (22)

1.43 (0.74, 2.75)

   Spontaneous vaginal

21 (42)

20 (41)

1.03 (0.64, 1.64)

   Instrumental

9 (18)

10 (20)

0.88 (0.39, 1.98)

   Caesarean section

20 (40)

18 (37)

1.09 (0.66, 1.80)

Birthweight (grams)

   

   < 2500

2 (4)

2 (4)

0.98 (0.14, 6.68)

   2500-3999

42 (84)

42 (86)

0.98 (0.83, 1.16)

   ≥4000 gms

6 (12)

4 (8)

1.47(0.44, 4.89)

Nursery admission

4 (8)

3 (6)

1.31 (0.31, 5.54)

  1. Relative risk (RR) and 95% confidence interval ((95% CI) of the outcomes in the clotrimazole versus usual care group
  2. PPROM - preterm prelabor rupture of the membranes
  3. * One woman who was lost to follow-up is included in the denominator