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. 2018 May;15(5):570–580. doi: 10.1513/AnnalsATS.201704-326OC

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 (%)ǁ 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%.

ǁDenominator 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.