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Future Journal of Pharmaceutical Sciences

Table 2 Intention-to-treat analysis results of the primary and secondary outcomes (N = 206)

From: Superiority trial of intermittent treatment with dihydroartemisinin–piperaquine versus sulfadoxine–pyrimethamine for the prevention of malaria during pregnancy

Outcomes

Gravidity

Trial groups

Crude RR

(95% CI)†

Adjusted RR (95% CI)†

SP (n = 94)

n (%)

DP (n = 112)

n (%)

Mean gestational age at delivery (weeks)

All gravidae

38.7 ± 2.4

38.85 ± 2.46

–

–

 

Primigravidae

38.6 ± 3.5

39.3 ± 1.4

–

–

 

Multigravidae

38.8 ± 1.6

38.6 ± 2.8

–

–

Rogerson placental malaria category

     

None

All gravidae

46 (48.9)

41 (36.9)

1.30 (0.97–1.75)

-

Acute

All gravidae

0 (0.0)

6 (5.4)

-

-

Chronic

All gravidae

20 (21.3)

27 (24.3)

1.10 (0.76–1.60)

-

Past

All gravidae

28 (29.8)

37 (33.4)

1.09 (0.79–1.52)

-

Placental malariaa

All gravidae

48 (51.1)

70 (62.5)

1.29 (0.96–1.73)

1.27 (0.94–1.71)

 

Primigravidae

13 (39.4)

27 (71.1)

1.99 (1.18–3.33)*

1.89 (1.13–3.16)*

 

Multigravidae

35 (57.4)

43 (58.9)

1.02(0.70–1.48)

0.97 (0.67–1.41)

Spontaneous abortion

All gravidae

2 (2.1)

1 (0.9)

0.68 (0.30–1.54)

-

 

Primigravidae

2 (6.1)

0 (0.0)

0.45 (0.35–0.58)*

-

 

Multigravidae

0 (0.0)

1 (1.4)

-

-

Stillbirth

All gravidae

0 (0.0)

0 (0.0)

-

-

 

Primigravidae

0 (0.0)

0 (0.0)

-

-

 

Multigravidae

0 (0.0)

0 (0.0)

-

-

Low birth weightb

All gravidae

15 (16.0)

11 (9.8)

0.76 (0.53–1.10)

0.75 (0.51–1.09)

 

Primigravidae

5 (15.2)

2 (5.3)

0.61 (0.36–1.06)

-

 

Multigravidae

10 (16.4)

9 (12.2)

0.84 (0.52–1.34)

0.62 (0.34–1.14)

Preterm delivery

All gravidae

5 (5.4)

6 (5.4)

1.01 (0.52–1.95)

-

 

Primigravidae

0 (0.0)

0 (0.0)

-

-

 

Multigravidae

5 (8.2)

6 (8.2)

0.99 (0.51–1.95)

-

Small for gestational ageb

All gravidae

3 (3.3)

4 (3.6)

1.07 (0.45–2.54)

1.12 (0.46–2.71)

 

Primigravidae

0 (0.0)

1 (2.6)

-

-

 

Multigravidae

3 (4.9)

3 (4.1)

0.90 (0.40–2.05)

0.98 (0.42–2.29)

Congenital malformation

All gravidae

0 (0.0)

0 (0.0)

-

-

 

Primigravidae

0 (0.0)

0 (0.0)

-

-

 

Multigravidae

0 (0.0)

0 (0.0)

-

-

Low APGAR score

All gravidae

5 (5.3)

0 (0.0)

0.45 (0.38–0.52)*

-

 

Primigravidae

2 (6.1)

0 (0.0)

0.45 (0.35–0.58)*

-

 

Multigravidae

3 (4.9)

0 (0.0)

0.44 (0.37–0.54)*

-

#Composite adverse birth outcomeb

All gravidae

15 (16.0)

13 (11.6)

0.83 (0.57–1.21)

0.82 (0.55–1.21)

 

Primigravidae

5 (15.2)

2 (5.3)

0.61 (0.36–1.06)

-

 

Multigravidae

10 (16.4)

11 (14.9)

0.94 (0.57–1.54)

0.97 (0.59–1.61)

  1. APGAR Appearance, Pulse, Grimace, Activity, and Respiration
  2. aAdjusted for gravidity, baseline maternal anemia, and age-group
  3. bAdjusted for gravidity, baseline maternal anemia, age-group and BMI category
  4. #Any adverse birth outcome (spontaneous abortion, low birth weight, preterm delivery, and small for gestational age) is included
  5. †SP group is the reference group for Relative Risk (RR) calculations
  6. *Significant at P < 0.05
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