Table 2.
Calculation around EDC as Reported by the Site | LMP Reported | Interpretation | Method for Estimating/Adjusting EDC | 3HP (n = 31) n | 9H (n = 56) n | Total (n = 87) n (%) |
---|---|---|---|---|---|---|
EDD(r) − EDC(r) = 266 ± 1 d | Yes or No | EDC reported was consistent | Accepted as reported | 3 | 11 | 14 (16.1) |
EDC(r) − (LMP + 14) = n ± 55 d | Yes | EDC reported was not consistent, used LMP | EDC estimated as, EDC = LMP + 14 | 13 | 18 | 31 (36.5) |
1) EDD(r) − DOB(r) in live birth = n ± 44 d, or | No | EDC reported was not consistent, used EDD | EDC estimated as, EDC = EDD − 266 | 13 | 24 | 37 (42.5) |
2) 233 < = EDD(r) − EDC(r) in non-live birth ≤283 | ||||||
EDD(r) − DOB(r) = n + 48 d | No | EDC reported was not consistent, used reported gestational age at birth | EDC estimated as, EDC = DOB − (gestational age in weeks × 7) | 1 | 0 | 1 (1.1) |
EDD(r) − DOB(r) = n ≤93 or EDD(r) − EDC(r), n ≥300 | No | EDC reported was not consistent, used DOB | EDC estimated as, DOB − 266 | 1 | 3 | 4 (4.6) |
Definition of abbreviations: 3HP = 12-dose once-weekly regimen of isoniazid (900 mg) plus rifapentine (900 mg); 9H = 9-month daily isoniazid (300 mg); DOB = date of birth; DOB(r) = DOB reported by the site; EDC = estimated date of conception; EDC(r) = EDC reported by the site; EDD = estimated delivery date; EDD(r) = EDD reported by the site (e.g., if a child was born prematurely, the calculation of EDD − 266 is still considered accurate, as EDD was calculated by the clinician at enrollment, most likely using LMP; however, LMP was not reported); LMP = last menstrual period.