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Table 2 LBW, preterm delivery, and mean birthweight, by treatment group

From: Sulphadoxine-pyrimethamine plus azithromycin for the prevention of low birthweight in Papua New Guinea: a randomised controlled trial

Outcome

ITT analysis

 

PP analysis

 
 

Control (SPCQ and placebo)

Intervention

(SPAZ)

Risk ratio or ∆ mean (95% CI)

P

Control (SPCQ and placebo)

Intervention

(SPAZ)

Risk ratio or ∆ mean (95% CI)

P

LBW (Birthweight < 2,500 g), unadjusted

175/1,008 (17.4)

130/1,013 (12.8)

0.74 (0.60–0.91)

0.005

159/952 (16.7)

122/967 (12.6)

0.76 (0.61–0.94)

0.011

LBW (Birthweight < 2,500 g), adjusteda

–

–

0.72 (0.59–0.89)

0.002

–

–

0.72 (0.58–0.89)

0.003

Birthweight (g)

2,921.6

2,963.5

41.9

0.049

2,928.7

2,967.9

39.2

0.068

unadjusted

[2,890.1–2,953.1]

[2,936.0–2,991.0]

(0.2–83.6)

 

[2,986.9–2,960.4]

[2,940.3–2,995.4]

(−2.8–81.2)

 

Birthweight (g)

2,916.6

2,969.0

52.4

0.009

2922.9

2974.1

51.2

0.011

adjustedb

[2,888.8–2944.3]

[2,941.4–2,996.6]

(13.2–91.6)

 

[2,895.0–2,950.9]

[2,946.4–3,001.8]

(11.7–90.6)

 

PTD (<37 GWs), n (%), unadjusted, best available dating ultrasound

69/652 (10.6)

44/668 (6.6)

0.62 (0.43–0.89)

0.010

63/622 (10.1)

40/651 (6.1)

0.61 (0.41–0.89)

0.009

  1. Data are number (%) or mean [95% CI], unless stated otherwise; ITT, Intention-to-treat; PP, Per-protocol; GW, Gestational weeks; CI, Confidence interval. P <0.05 marked in bold.
  2. aAdjusted for infant gender, gravidity, no. of treatment courses (ITT only), clinic location, season of delivery, bed net use, mid-upper arm circumference, height, maternal highlander heritage.
  3. bAdjusted for infant gender, gravidity, no. of treatment courses (ITT only), clinic location, mid-upper arm circumference, height, maternal highlander heritage.