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Table 5 Sensitivity analysis of pregnancy outcomes of 936 women with gestational diabetes mellitus by assignment

From: A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes

 

UC (n = 470)

SC (n = 466)

 

SC vs. UC

Outcomes

Mean (SD) or n(%)

Mean (SD) or n(%)

P value

Unadjusted RR (95% CI)

Delivery at a tertiary hospital

314(66.8%)

334(71.7%)

0.107

 

Gestational weeks at delivery

39.1(2.1)

39.4(2.5)

0.063

 

Primary outcome

    

Birth weight ≥4.0 kg

73(15.6%)

58(12.5%)

0.170

0.80(0.58-1.10)

Secondary outcome

    

Pregnancy-induced hypertension

22(4.7%)

33(7.1%)

0.118

1.51(0.90-2.56)

Other infant outcomes

    

Birth weight, g

3445(587)

3415(527)

0.412

 

Body stature of neonates, cm

50.2(2.0)

50.2(1.8)

0.694

 

Infant male gender

244(51.9%)

271(58.2%)

0.055

 

Large for gestational age†

89(18.9%)

65(14.0%)

0.040

0.74(0.55-0.99)

Birth weight ≥4.5 kg

12(2.6%)

14(3.0%)

0.679

1.17(0.55-2.51)

Birth weight < 2.5 kg

22(4.7%)

15(3.2%)

0.251

0.68(0.36-1.31)

Apgar score at 1 min <7

14(3.0%)

3(0.6%)

0.008

0.22(0.06-0.75)

Neonatal hypoglycemia†

4(0.9%)

2(0.4%)

0.418

0.50(0.09-2.74)

Birth trauma or shoulder dystocia

0

0

-

-

Bone fracture

0

0

-

-

Stillbirth or neonatal death

5(1.1%)

5(1.1%)

0.989

1.01(0.29-3.46)

Other maternal or delivery outcomes

    

Induced labor

2(0.4%)

0

0.500

 

Preterm birth

37(7.9%)

22(4.7%)

0.047

0.60(0.36-1.00)

Premature rupture of membrane

83(17.7%)

74(15.9%)

0.466

0.90(0.68-1.20)

Caesarean delivery

302(64.3%)

333(71.5%)

0.018

1.11(1.02-1.22)

Preeclampsia

12(2.6%)

21(4.5%)

0.105

1.76(0.88-3.55)

Gestational hypertension

10(2.1%)

12(2.6%)

0.651

1.21(0.53-2.77)

  1. Abbreviations: SC shared intensive care, UC usual care.
  2. †Large for gestational age was defined by gender and gestational age specific 90th percentiles.
  3. †Defined as capillary blood glucose <1.7 mmol/L.