Table 3.

Systematically assessed, self-reported, aspirin-related selected symptoms and emergency care visits by pregnancy status and treatment arm: the Effects of Aspirin in Gestation and Reproduction trial.

Symptoms and emergency care visits	Low-dose aspirin N=615 n (%)	Placebo N=613 n (%)	RD	95% CI	P
Not pregnant at time of interview (n= 1211)	n=605	n=606
Symptom
Any symptom	319 (53)	307 (51)	2.1	−3.6 – 7.7	0.49
Any gastrointestinal discomfort	219 (36)	217 (36)	0.4	−5.0 – 5.8	0.91
Any nausea or vomiting *	116 (19)	122 (20)	−1.0	−5.4 – 3.5	0.72
Any unusual or excessive bleeding	141 (23)	134 (22)	1.2	−3.5 – 5.9	0.63
Any vaginal bleeding *	78 (13)	74 (12)	0.7	−3.1 – 4.4	0.73
Any swelling	20 (3)	9 (2)	1.8	0.1 – 3.5	0.04
Any breathing difficulty	24 (4)	28 (5)	−0.7	−2.9 – 1.6	0.67
Any emergency care visit	30 (5)	33 (5)	−0.5	−3.0 – 2.0	0.80
Pregnant at time of interview (n= 684)†	n=347.1	n=336.9
Symptom
Any symptom	287.4 (83)	275.6 (82)	1.0	−5.0 – 7.0	0.73
Any gastrointestinal discomfort	268.2 (77)	254.8 (76)	1.6	−5.0 – 8.3	0.61
Any nausea or vomiting *	210.5 (60)	200.9 (62)	−1.1	−8.6 – 6.4	0.77
Any unusual or excessive bleeding	98.2 (28)	90.8 (27)	1.3	−5.6 – 8.3	0.69
Any vaginal bleeding *	57.1 (16)	59.2 (18)	−1.1	−7.0 – 4.8	0.70
Any swelling	59.1 (17)	49.2 (15)	2.4	−3.4 – 8.2	0.39
Any breathing difficulty	42.7 (12)	43.8 (13)	−0.7	−5.8 – 4.4	0.79
Any emergency care visit	77.3 (22)	77 (23)	−0.6	−7.1 – 5.9	0.85

Abbreviation: RD, risk difference; CI, confidence interval

P-value calculated using Fisher’s exact test (unweighted data) or Chi-squared test (weighted data). P<0.05 bolded.

^*Questions specifically assessing nausea/vomiting and vaginal bleeding were added to the interview approximately 15 months into recruitment.

^†For women pregnant at the time of the interview, inverse probability of conception weights were applied to control for selection bias introduced by stratifying on pregnancy status.