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Table 4 Tacrolimus-aspirin combination therapy and its effect on adverse pregnancy outcomes

From: A retrospective analysis of the safety of tacrolimus use and its optimal cut-off concentration during pregnancy in women with systemic lupus erythematosus: study from two Japanese tertiary referral centers

 

Tacrolimus + aspirin combination therapy

logistic regression analysis

Factor

Tacrolimus only

Tacrolimus + aspirin

p value

OR

95% CI

p value

n

13

16

    

Overall APO (%)

7 (53.8)

9 (56.2)

1.00

1.10

0.25–4.8

0.90

Maternal APO (%)

5 (38.5)

8 (50.0)

0.80

1.60

0.36–7.07

0.54

Neonatal APO (%)

8 (61.5)

7 (43.8)

0.56

0.49

0.11–2.16

0.34

PROMISSE APO (%)

2 (15.4)

3 (18.8)

1.00

1.27

0.18–9.02

0.81

Flare during pregnancy (%)

3 (23.1)

5 (31.2)

0.70

1.52

0.29–8.03

0.63

flare after delivery (%)

1 (10.0)

1 (7.7)

1.0

0.75

0.04–13.7

0.85

Hypertensive Disorders of Pregnancy (%)

4 (30.8)

3 (18.8)

0.67

0.52

0.93–2.90

0.46

Preeclampsia (%)

2 (15.4)

1 (6.2)

0.57

0.37

0.03–4.57

0.44

Eclampsia (%)

0 (0.0)

0 (0.0)

NA

NA

NA

NA

HELLP syndrome (%)

0 (0.0)

0 (0.0)

1.00

NA

NA

NA

Gestational DM (%)

2 (15.4)

4 (25.0)

0.66

1.83

0.28–12.1

0.53

Oligohydramnios (%)

1 (7.7)

0 (0.0)

0.45

NA

NA

NA

Maternal death (%)

0 (0.0)

0 (0.0)

NA

NA

NA

NA

Total duration of gestation (days)

263 [166, 273]

266 [245.8, 272]

0.71

NA

NA

NA

Preterm birth (%)

3 (27.3)

2 (14.3)

0.62

0.44

0.06–3.29

0.43

Spontaneous abortion (%)

1 (8.3)

1 (6.7)

1.00

0.79

0.04–14

0.87

Missed abortion (%)

1 (7.7)

0 (0.0)

0.48

NA

NA

NA

Iatrogenic abortion (%)

1 (7.7)

2 (12.5)

1.00

1.70

0.14–21.3

0.68

Still birth (%)

0 (0.0)

0 (0.0)

NA

NA

NA

NA

Planned C section (%)

1 (10.0)

2 (15.4)

1.00

1.64

0.13–21.1

0.71

Emergency C section (%)

6 (60.0)

7 (53.8)

1.00

0.78

0.15–4.13

0.77

Height at birth (cm)

46.3 [43.8, 49.9]

48.0 [44.0, 50.0]

0.64

NA

NA

NA

Weight at birth (g)

2577 [2123, 2889]

2882 [2532, 3025]

0.17

NA

NA

NA

Low birth weight (%)

5 (50.0)

3 (23.1)

0.22

0.30

0.05–1.80

0.19

SGA (%)

2 (20.0)

2 (15.4)

1.00

0.73

0.08–6.31

0.77

Apgar score > 7 (1 min)

8 (80.0)

13 (100.0)

0.35

NA

NA

NA

Apgar score > 7 (5 min)

9 (90.0)

13 (100.0)

0.89

NA

NA

NA

Major malformation (%)

0 (0.0)

1 (7.7)

1.00

NA

NA

NA

Death of the neonate (%)

1 (10.0)

0 (0.0)

0.44

NA

NA

NA

  1. APO adverse pregnancy outcome, DM diabetes mellitus, HELLP hemolysis, elevated liver enzymes and low platelets, NA not available, OR odds ratio, PROMISSE Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus, PROM Premature rupture of membranes, SGA small for gestational age