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.