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Table 2 Clinical and haematological findings of enrolled women, by intervention arm

From: Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother-to-child transmission: a randomized trial in three African countries

Characteristic

Cohort 1:

Cohort 2:

RCT arm A:

RCT arm B:

P-valuei

ART (CD4 < 200)

ZDV plus sdNVP (CD4 > 500)

Triple ARV (CD4 200–500)

ZDV plus sdNVP (CD4 200–500)

(n visits = 1514)

(n visits = 1371)

(n visits = 4467)

(n visits = 4381)

Median weeks of antiretroviral use (IQR)

112.8

5.9

22.1

6.7

NA

 

(85.1-117.7)

(4.7-6.8)

(10.6-32.4)

(4.6-8.9)

 

Number of women who never initiated breastfeeding (formula only), n (%)

46 (38.9)

31 (24.2)

104 (25.2)

104 (25.2)

0.899*

Median weeks of breastfeeding if initiated (IQR)

19.1

17.9

20.9

19.6

0.898

(11.9-23.2)

(12.1-24.7)

(11.9-24.9)

(11.3-25.0)

 

Breastfeeding duration if initiated, n (%)

     

 <3 months

28 (43.8)

42 (46.1)

120 (41.2)

133 (44.8)

 

 ≥3 months

36 (56.2)

49 (53.9)

171 (58.8)

164 (55.2)

0.385

Median CD4 count [cells/mm3] (IQR)

     

 At enrolment

134.5 (91–170)

621.5 (559–810)

335.5 (282–408)

338.5 (267–408)

0.428*

 At delivery

184 (129–277)

742 (602.5-910)

462.5 (383–603)

415 (331–527)

<0.001*

 At 6 months postpartum

274 (207–364)

731 (616–870)

479 (369–597)

374 (292–471)

<0.001*

 At 12 months postpartum

304 (228–419)

683.5 (543–889)

401 (319.5-518)

378 (287–469)

0.509*

Median Hb [g/dL] (IQR)

     

 At enrolment

9.9 (8.9-11.0)

10.9 (9.9-12.7)

10.2 (9.2-11.1)

10.2 (9.1-11.1)

0.440*

 At delivery

10.0 (8.9-11.8)

11.3 (10.2-13.3)

10.6 (9.6-11.6)

10.6 (9.4-11.8)

0.948*

 At 6 months postpartum

11.8 (11.1-13.0)

13.1 (11.8-14.3)

11.9 (11.1-12.8)

11.7 (10.9-12.6)

0.075*

 At 12 months postpartum

11.9 (11.0-12.9)

12.5 (11.4-13.6)

11.5 (10.7-12.5)

11.3 (10.3-12.2)

0.078*

Median MCV [fL] (IQR)

     

 At enrolment

86 (78–91)

85 (78–91)

87 (81–93)

88.5 (82–94)

0.866*

 At delivery

91 (84–98)

88 (80–93)

91 (83–99)

93 (85–101)

0.325*

 At 6 months postpartum

103 (96–110)

82 (77–90)

91 (83–100)

85 (79–90)

<0.001*

 At 12 months postpartum

102 (95–110)

82 (75–89)

83 (77–89)

84 (78–90)

0.118*

Proportion with macrocytosis (95% CI)

     

 At enrolment

0.03 (0.01-0.08)

0.05 (0.02-0.10)

0.10 (0.07-0.13)

0.07 (0.05-0.10)

0.259**

 At delivery

0.21 (0.14-0.30)

0.08 (0.04-0.15)

0.23 (0.18-0.27)

0.28 (0.24-0.33)

0.112*

 At 6 months postpartum

0.63 (0.53-0.71)

0.01 (0.00-0.07)

0.26 (0.21-0.30)

0.03 (0.02-0.06)

<0.001*

 At 12 months postpartum

0.61 (0.51-0.70)

0.01 (0.00-0.07)

0.06 (0.03-0.10)

0.09 (0.06-0.14)

0.144*

Proportion with any anaemia (Hb < 11 g/dL) (95% CI)

     

 At enrolment

0.74 (0.65-0.82)

0.55 (0.46-0.64)

0.71 (0.66-0.75)

0.72 (0.68-0.76)

0.627*

 At delivery

0.71 (0.61-0.79)

0.43 (0.33-0.52)

0.61 (0.56-0.66)

0.59 (0.54-0.64)

0.561*

 At 6 months postpartum

0.25 (0.18-0.34)

0.12 (0.06-0.2)

0.23 (0.19-0.28)

0.26 (0.21-0.30)

0.398

 At 12 months postpartum

0.21 (0.14-0.30)

0.16 (0.09-0.25)

0.32 (0.26-0.38)

0.39 (0.34-0.45)

0.228*

Proportion with severe anaemia (Hb < 8 g/dL) (95% CI)

     

 At enrolment

0.09 (0.05-0.16)

0.04 (0.01-0.09)

0.06 (0.04-0.09)

0.07 (0.04-0.09)

0.671

 At delivery

0.15 (0.09-0.23)

0.06 (0.02-0.12)

0.06 (0.04-0.09)

0.10 (0.07-0.13)

0.144*

 At 6 months postpartum

0.02 (0–0.06)

0.01 (0.00-0.06)

0.01 (0.00-0.03)

0.02 (0.01-0.04)

0.255

 At 12 months postpartum

0.01 (0–0.04)

0.00 (0.00-0.04)

0.02 (0.00-0.08)

0.03 (0.01-0.09)

0.678

Cumulative incidence of severe anaemia (Hb < 8 g/dL) (95% CI)

     

 At delivery

0.14 (0.09-0.22)

0.05 (0.03-0.11)

0.09 (0.06-0.12)

0.08 (0.06-0.11)

0.512*

 At 6 months postpartum

0.30 (0.23-0.39)

0.10 (0.06-0.16)

0.16 (0.13-0.20)

0.17 (0.14-0.21)

0.436*

 At 12 months postpartum

0.33 (0.26-0.41)

0.11 (0.06-0.17)

0.18 (0.14-0.21)

0.19 (0.16-0.23)

0.712*

 At 18 months postpartum

0.34 (0.27-0.42)

0.11 (0.06-0.17)

0.18 (0.15-0.22)

0.21 (0.17-0.25)

0.356*

Overall incidence of severe anaemia per person year (Hb < 8 g/dL) (95% CI)

0.21

0.06

0.12

0.14

0.317*

(0.16-0.27)

(0.04-0.10)

(0.10-0.15)

(0.12-0.18)

 

Number of single failures only (Hb < 8 g/dL), n (%)

28 (23.7)

11 (8.6)

49 (11.9)

65 (15.8)

0.129*

Number of individuals with repeat failures (Hb < 8 g/dL), n (%)

11 (9.3)

2 (1.6)

14 (3.6)

14 (3.3)

0.708*

Summed ii number of repeat failures, n

24

4

35

32

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  1. CI = confidence interval; IQR inter-quartile range; SD = standard deviation; Hb = haemoglobin; ART = antiretroviral therapy; triple ARV = triple-antiretroviral prophylaxis; ZDV plus sdNVP = zidovudine plus single-dose nevirapine; i: comparing RCT arms only: χ2 (or Fishers Exact) test for categorical variables, Student's t test for comparison of two means or ANOVA for comparison of multiple means, Rank Sum test if data were highly skewed, and log-rank test for equality of survivor functions; ii: individuals x number of failures; *P-value <0.05 based on comparison of all 4 groups; **p-value between 0.05 and 0.10 in comparison of all 4 groups.