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Table 2 Frequency of endpoints by trimester of diagnosis

From: Fetal adverse effects following NSAID or metamizole exposure in the 2nd and 3rd trimester: an evaluation of the German Embryotox cohort

 

Study cohort, pregnancies (n, 1092), exposure: 2nd and/or 3rd trimester,

n (%)

Comparison cohort, pregnancies (n, 1154), exposure: 1st trimester,

n (%)

Risk ratio, RR (95% CI)

Constriction of ductus arteriosus

5/1092 (0.5)

0/1154 (0.0)

 

  •2nd trimester

1/904 (0.1)

0/1154 (0.0)

 

  •3rd trimester

2/1092 (0.2)

0/1154 (0.0)

 

  •Not clearly assignable to trimester

2/1092 (0.2)

0/1154 (0.0)

 

Oligohydramnios

41/1092 (3.8)

29/1154 (2.5)

1.5 (0.9–2.4)

  •2nd trimester

8/904 (0.9)

2/1154 (0.2)

5.1 (1.1–24.0)

  •3rd trimester

23/1092 (2.1)

20/1154 (1.7)

 

  •Not clearly assignable to trimester

10/1092 (0.9)

7/1154 (0.6)

 

Late SAB/fetal death

14/1092 (1.3)

17/1154 (1.5)

 

  •2nd trimester

11/904 (1.2)

12/1154 (1.0)

 

  •3rd trimester

3/1092 (0.3)

5/1154 (0.4)

 

ETOP (after 1st trimester)

10/1092 (0.9)

16/1154 (1.4)

 
 

Live-born infants

(n, 1098)

Live-born infants

(n, 1133)

 

Patent ductus arteriosus

15/1098 (1.4)

10/1133 (0.9)

1.6 (0.7–3.4)

  •term-born (≥ 37 + 0 GW)

4/933a (0.4)

5/1010a (0.5)

0.9 (0.2–3.2)

  •preterm-born (<  37 + 0 GW)

11/162a (6.8)

5/117a (4.3)

1.6 (0.6–4.5)

PPHT and other cardiac anomaliesb

5/1098 (0.5)

2/1133 (0.2)

2.6 (0.5–13.3)

Renal disorder

1/1098 (0.1)

1/1133 (0.1)

1.0 (0.1–16.5)

  1. Multiple endpoints in one pregnancy are listed and counted separately. a Number of live-born infants with information on gestational week (GW) at birth. b Other cardiac anomalies include tricuspid insufficiency and right ventricular load. Only those pregnancies definitely exposed in the 2nd trimester were considered to calculate the frequency in the 2nd trimester. ETOP Elective termination of pregnancy, PPHT Primary pulmonary hypertension, SAB Spontaneous abortion