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ACR Appropriateness Criteria® First Trimester Bleeding EVIDENCE TABLE

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ACR Appropriateness Criteria® First Trimester Bleeding EVIDENCE TABLE ACR Appropriateness Criteria® First Trimester Bleeding EVIDENCE TABLE Patients/ Study Objective Study Reference Study Type Study Results Events (Purpose of Study) Quality 1. Hasan R, Baird DD, Herring AH, Olshan Review/Other 4,539 To characterize the patterns and predictors of Approximately one-fourth of participants 4 AF, Jonsson Funk ML, Hartmann KE. -Dx patients early pregnancy bleeding, setting aside (n=1,207) reported bleeding (n=1,656 Patterns and predictors of vaginal bleeding episodes that occur at the time of episodes), but only 8% of women with bleeding in the first trimester of miscarriage. bleeding, reported heavy bleeding. Of the pregnancy. Ann Epidemiol 2010; spotting and light bleeding episodes 20(7):524-531. (n=1,555), 28% were associated with pain. Among heavy episodes (n=100), 54% were associated with pain. Most episodes lasted less than 3 days, and most occurred between gestational weeks 5–8. 12% of women with bleeding and 13% of those without experienced miscarriage. Maternal characteristics associated with bleeding included fibroids and prior miscarriage. Consistent with the hypothesis that bleeding is a marker for placental dysfunction, bleeding is most likely to be seen around the time of the luteal-placental shift. 2. Bree RL, Edwards M, Bohm-Velez M, Review/Other 53 patients; Compare TVUS with -hCG level in the -hCG level of 1000 mIU/ml - gestational sac 4 Beyler S, Roberts J, Mendelson EB. -Dx 75 TVUS evaluation of embryo in early pregnancy. was seen sonographically in each patient. - Transvaginal sonography in the evaluation examinations hCG level of 7200 mIU/ml - yolk sac was of normal early pregnancy: correlation seen in every patient. 10/22 patients with - with HCG level. AJR 1989; 153(1):75-79. hCG between 1000 and 7200 mIU/ml had a visible yolk sac. Every patient with -hCG level >10,800 mIU/ml had a visible embryo with a heartbeat. Results support other studies that TVUS can define pregnancy as early as 32 days and at -hCG levels as low as 1000 mIU/ml. 3. Bradley WG, Fiske CE, Filly RA. The Review/Other 50 suspected Retrospective review of pelvic sonograms to Double sac appearance is a useful indicator 4 double sac sign of early intrauterine -Dx ectopic determine the usefulness of double sac sign in for differentiating an ectopic pregnancy from pregnancy: use in exclusion of ectopic pregnancy differentiating ectopic pregnancy from early an early normal IUP. pregnancy. Radiology 1982; 143(1):223- patients; 17 IUP. 226. proved ectopic cases 4. Parvey HR, Dubinsky TJ, Johnston DA, Observational 169 with Review sonograms to determine whether 126/238 patients had Doppler examination. 3 Maklad NF. The chorionic rim and low- -Dx early IUP; 69 sonographic imaging of an intrauterine Chorionic rim and double decidual sac had impedance intrauterine arterial flow in the with ectopic chorionic rim or arterial flow can help sensitivities of 80% and 64%, respectively, diagnosis of early intrauterine pregnancy: diagnose an early IUP. and specificities of 97% and 100%, evaluation of efficacy. AJR 1996; respectively. Intrauterine arterial flow with 167(6):1479-1485. either peak systolic velocity ≥15 cm/sec or resistive index ≤0.55 had a sensitivity of 70% and a specificity of 95%. * See Last Page for Key 2012 Review Lane/Wong Page 1 ACR Appropriateness Criteria® First Trimester Bleeding EVIDENCE TABLE Patients/ Study Objective Study Reference Study Type Study Results Events (Purpose of Study) Quality 5. Laing FC, Brown DL, Price JF, Teeger S, Observational 102 patients Retrospective study to determine if the Sensitivity for diagnosis of an IUP was 34%- 2 Wong ML. Intradecidual sign: is it -Dx 4 observers intradecidual sign at sonography is effective 66%, specificity was 55%-73%, accuracy was effective in diagnosis of an early in the diagnosis of early IUP. 38%-65%, PPV was 91%-93%, and NPV was intrauterine pregnancy? Radiology 1997; 12%-16%. 204(3):655-660. 6. Yeh HC, Goodman JD, Carr L, Observational 36 patients To determine the accuracy of the intradecidual Intradecidual sign was more sensitive (91.7% 4 Rabinowitz JG. Intradecidual sign: a US -Dx with IUP; 5 sign (a feature on sonograms) in the detection vs 63.9%) and specific (100% vs 60%) than criterion of early intrauterine pregnancy. patients with of early IUP. the double decidual sac sign in the detection Radiology 1986; 161(2):463-467. ectopic of early IUP. 7. Chiang G, Levine D, Swire M, McNamara Observational 153 patients Retrospective study to determine if Patients with IUP had sensitivity of 70%. 2 A, Mehta T. The intradecidual sign: is it -Dx with IUP; 34 intradecidual sign is accurate for the diagnosis Ectopic pregnancies had specificity of 100% reliable for diagnosis of early intrauterine patients with of IUP and the exclusion of ectopic for the intradecidual sign; the accuracy rate pregnancy? AJR 2004; 183(3):725-731. ectopic; 3 pregnancy. was 75%, PPV 100%, and NPV 43%. observers Sensitivity for diagnosis of an IUP increases when -hCG levels are ≥2,000 mIU/ml or the mean sac diameter ≥3 mm. 8. Mehta TS, Levine D, Beckwith B. Review/Other 676 patients Review medical records and US scans to 548 patients had evidence of a normal or 4 Treatment of ectopic pregnancy: is a -Dx determine whether hCG level of 2,000 abnormal IUP. 51 (40%) of the 128 patients human chorionic gonadotropin level of mIU/ml is a reasonable threshold for without evidence of an IUP had an hCG level 2,000 mIU/mL a reasonable threshold? diagnosing ectopic pregnancy in the absence >2,000 mIU/ml. Of 51 patients, 15 (29%) Radiology 1997; 205(2):569-573. of US findings of IUP in order to prevent were treated for ectopic pregnancy; 17 (33%) inappropriate treatment. were not immediately treated for ectopic pregnancy and had a normal IUP at follow-up US. hCG level of 2,000 mIU/ml without US findings of IUP is not diagnostic. 9. Nyberg DA, Filly RA, Mahony BS, Review/Other 49 patients Compare hCG levels with US findings in A gestational sac was always visible when the 4 Monroe S, Laing FC, Jeffrey RB, Jr. Early -Dx patients with normal early IUP to determine hCG level was 1800 mIU/ml in 36 cases and gestation: correlation of HCG levels and the discriminatory level of β-hCG. 357 mlU/ml in one case. Comparison of sonographic identification. AJR 1985; serum hCG levels with US detection is useful 144(5):951-954 for evaluating early pregnancy. * See Last Page for Key 2012 Review Lane/Wong Page 2 ACR Appropriateness Criteria® First Trimester Bleeding EVIDENCE TABLE Patients/ Study Objective Study Reference Study Type Study Results Events (Purpose of Study) Quality 10. Doubilet PM, Benson CB. Further Observational 202 patients To determine whether a woman with a β-hCG 162 (80.2%) women had β-hCG levels below 3 evidence against the reliability of the -Dx above 2000 mIU/mL and no intrauterine fluid 1000 mIU/mL on the day of the initial scan human chorionic gonadotropin collection on TVUS can subsequently be showing no intrauterine fluid collection, 19 discriminatory level. J Ultrasound Med found to have a live intrauterine gestation and, (9.4%) with levels of 1000 to 1499, 12 (5.9%) 2011; 30(12):1637-1642. if so, what the prognosis is for the pregnancy. 1500 to 1999, and 9 (4.5%) above 2000 mIU/mL. There was no significant relationship between initial β-hCG level and either first-trimester outcome or final pregnancy outcome (P>.05, logistic regression analysis and Fisher exact test). The highest β- hCG was 6567 mIU/mL, and the highest value that preceded a liveborn term baby was 4336 mIU/mL. The hCG discriminatory level should not be used to determine the management of a hemodynamically stable patient with suspected ectopic pregnancy, if sonography demonstrates no findings of intrauterine or ectopic pregnancy. 11. Levi CS, Lyons EA, Lindsay DJ. Early Observational 62 patients Retrospective analysis of prospectively 59 patients with gestation sacs ≥8 mm; 4 diagnosis of nonviable pregnancy with -Dx accumulated data to determine first trimester absence of a yolk sac predicted a nonviable endovaginal US. Radiology 1988; nonviability at endovaginal US on the basis of pregnancy with sensitivity of 67%, specificity 167(2):383-385. gestational sac size and the presence or of 100%. 35 patients with gestation sacs ≥16 absence of a yolk sac or embryo. mm; absence of embryo predicted a nonviable pregnancy with sensitivity of 50% and specificity of 100%. Combining gestation sac size; demonstration of yolk sac, embryo and/or cardiac pulsations) helped in the diagnosis of a nonviable pregnancy with endovaginal US. * See Last Page for Key 2012 Review Lane/Wong Page 3 ACR Appropriateness Criteria® First Trimester Bleeding EVIDENCE TABLE Patients/ Study Objective Study Reference Study Type Study Results Events (Purpose of Study) Quality 12. Abdallah Y, Daemen A, Kirk E, et al. Observational 1,060 Observational cross-sectional study to define Of the 1,060 women with a diagnosis of IUP 3 Limitations of current definitions of -Dx consecutive the false-positive rate for the diagnosis of of uncertain viability, 473 remained viable miscarriage using mean gestational sac women miscarriage associated with different CRL and and 587 were non-viable by the time of the diameter and crown-rump length MSD measurements with or without a yolk 11-14-week scan. In the absence of both measurements: a multicenter sac in a large study population of patients embryo and yolk sac, the false-positive rate observational study. Ultrasound Obstet attending early pregnancy clinics. The authors for miscarriage was 4.4% when an MSD cut- Gynecol 2011; 38(5):497-502.
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