Table 3.

Pregnancy outcomes of those considered exposed to study drugs versus all reported pregnancies

Outcome	Pregnancies Exposed to Study Drugs			All Reported Pregnancies
	3HP (n = 31)	9H (n = 56)	Total (n = 87)	3HP (n = 54)	9H (n = 72)	Total (n = 126)
Pregnancy outcomes
Live birth, n (%)	20 (65)	41 (73)	61 (70)	37 (69)	56 (78)	93 (74)
Elective abortion, n (%)	7(23)	7(13)	14(16)	9 (17)	7 (10)	16 (13)
Fetal loss (all are spontaneous abortion <20 wk), n (%)	4 (13)*	8 (14)*	12 (14)†	8 (15)‡	9 (13)‡	17 (13)§
Fetal loss, n (%) 95% CI of individual proportion	4/31 (13) (4–30)	8/56 (14) (6–26)	12/87 (14) (7–23)	8/54 (15) (7–27)	9/72 (13) (6–22)	17/126 (13) (8–21)
Infant outcomes
Congenital anomalies, n (%)‖	0¶	2 (5)¶	2 (3)**	1 (3)††	2 (4)††	3 (3)‡‡
Congenital anomalies, n (%) 95% CI of individual proportion	0/20 (0) (0–17)	2/41 (5) (1–17)	2/61 (3) (0–11)	1/37 (3) (0–14)	2/56 (4) (0–12)	3/93 (3) (1–9)

Definition of abbreviations: 3HP= 12-dose once-weekly regimen of isoniazid (900 mg) plus rifapentine (900 mg); 9H = 9-month daily isoniazid (300 mg); CI = confidence interval.

The 95% CI of individual proportions (Fisher Exact [Clopper-Pearson]) of fetal loss and congenital anomalies for each regimen (e.g., number of fetal losses among pregnancies exposed to 3HP [numerator] divided by the number of pregnancies exposed to 3HP [denominator]); 95% CI (with continuity correction) for the difference of proportions between regimens for fetal loss and congenital anomalies (e.g., number of fetal losses among pregnancies exposed to 3HP [numerator] divided by number of pregnancies exposed to 3HP [denominator] minus number of fetal losses among pregnancies exposed to 9H [numerator] divided by number of pregnancies exposed to 9H [denominator]). Proportion of fetal loss in this study compared to the proportion estimated for the United States (e.g., total number of fetal losses [numerator] divided by number of pregnancies exposed to study drugs during the trial [denominator] minus the estimated U.S. proportion of fetal loss [1,118/6,578 (17%)]).

Fetal loss (all are spontaneous abortion <20 wk) among pregnancies exposed to study drugs (n = 87):

^*Fetal loss in 3HP (4/31 [13%]) and 9H (8/56 [14%]): difference, 13% – 14% = −1%; 95% CI= −17% to +18%.

^†Fetal loss (12/87 [14%]) and the estimated U.S. rates (1,118/6,578 [17%]) (21): difference, 14% – 17% = −3%; 95% CI = −9% to +6%.

Fetal loss (all are spontaneous abortion <20 wk) among all reported pregnancies (n = 126):

^‡Fetal loss in 3HP (8/54 [15%]) and 9H (9/72 [13%]): difference, 15% – 13% = 2%; 95% CI = −11% to +17%

^§Fetal loss (17/126 [13%]) and the estimated for United States (1,118/6,578 [17%]) (21): difference, 13% – 17% = −4%; 95% CI = −9% to +4%.

^‖Denominator is number of total births.

Congenital anomalies among pregnancies exposed to study drugs (n = 87):

^¶Congenital anomalies in 3HP (0/20 [0%]) and 9H (2/41 [5%]): difference, 0% – 5% = −5%; 95% CI = −18% to +16%

^**Congenital anomalies (2/61 [3%]) and the U.S. estimate (3%) (only the point estimate is provided in the reference) (22): difference, 3% – 3% = 0.

One infant with congenital heart anomaly, bilateral cleft lip, and palate (mother’s age = 29 yr, 80 9H doses received); one infant with pyloric stenosis (mother’s age = 26 yr, 26 9H doses received).

Congenital anomalies among all reported pregnancies (n = 126):

^††Congenital anomalies in 3HP (1/37 [3%]) and 9H (2/56 [4%]): difference, 3% – 4%= −0.9%; 95% CI= −11% to +13%.

^‡‡Congenital anomalies (3/93 [3%]) and the U.S. estimate (only the point estimate is provided in the reference) (3%) (22): difference, 3% – 3% = 0.

One infant with congenital heart anomaly, bilateral cleft lip and palate (mother’s age = 29, 80 9H doses received); one infant with pyloric stenosis (mother’s age = 26 yr, 26 9H doses received); one Turner syndrome (mother’s age = 35 yr, 12 3HP doses received), conception date was estimated as 53 days after the last study dose.