Evaluating cut-off levels for progesterone, ß human chorionic gonadotropin and ß human chorionic gonadotropin ratio to exclude pregnancy viability in women with a pregnancy of unknown location: A prospective multicenter cohort study.

INTRODUCTION: There is no global agreement on how to best determine pregnancy of unknown location viability and location using biomarkers. Measurements of progesterone and ß human chorionic gonadotropin (ßhCG) are still used in clinical practice to exclude the possibility of a viable intrauterine pregnancy (VIUP). We evaluate the predictive value of progesterone, ßhCG, and ßhCG ratio cut-off levels to exclude a VIUP in women with a pregnancy of unknown location. MATERIAL AND METHODS: This was a secondary analysis of prospective multicenter study data of consecutive women with a pregnancy of unknown location between January 2015 and 2017 collected from dedicated early pregnancy assessment units of eight hospitals. Single progesterone and serial ßhCG measurements were taken. Women were followed up until final pregnancy outcome between 11 and 14 weeks of gestation was confirmed using transvaginal ultrasonography: (1) VIUP, (2) non-viable intrauterine pregnancy or failed pregnancy of unknown location, and (3) ectopic pregnancy or persisting pregnancy of unknown location. The predictive value of cut-off levels for ruling out VIUP were evaluated across a range of values likely to be encountered clinically for progesterone, ßhCG, and ßhCG ratio. RESULTS: Data from 2507 of 3272 (76.6%) women were suitable for analysis. All had data for ßhCG levels, 2248 (89.7%) had progesterone levels, and 1809 (72.2%) had ßhCG ratio. The likelihood of viability falls with the progesterone level. Although the median progesterone level associated with viability was 59 nmol/L, VIUP were identified with levels as low as 5 nmol/L. No single ßhCG cut-off reliably ruled out the presence of viability with certainty, even when the level was more than 3000 IU/L, there were 39/358 (11%) women who had a VIUP. The probability of viability decreases with the ßhCG ratio. Although the median ßhCG ratio associated with viability was 2.26, VIUP were identified with ratios as low as 1.02. A progesterone level below 2 nmol/L and ßhCG ratio below 0.87 were unlikely to be associated with viability but were not definitive when considering multiple imputation. CONCLUSIONS: Cut-off levels for ßhCG, ßhCG ratio, and progesterone are not safe to be used clinically to exclude viability in early pregnancy. Although ßhCG ratio and progesterone have slightly better performance in comparison, single ßhCG used in this manner is highly unreliable.

Tubo-ovarian abscess: A proposed new scoring system to guide clinical management.

OBJECTIVE: To create a risk scoring system comprised of clinical and radiological characteristics that can predict the likelihood of antibiotic treatment failure of tubo-ovarian abscesses. The score should guide clinicians in identifying patients to whom early intervention should be offered instead of a prolonged trial of antibiotics. METHODS: A multicenter, retrospective cohort study carried out between January 1, 2013 and September 30, 2019, identified consecutive patients with tubo-ovarian abscess. Using a chronological split, patients were allocated to two groups for the development and subsequent validation of the postulated scoring system. Univariate and bivariate analyses were performed to identify statistically significant variables for the failure of intravenous antibiotic treatment. RESULTS: In total, 214 consecutive patients with tubo-ovarian abscesses were identified. Data from the first 150 patients were used for the development of the postulated scoring system; data from the subsequent 64 patients were used for validation. Statistically significant clinical features between those having successful and unsuccessful management were: temperature (median = 37.1℃ vs 38.2℃, P = 0.0001), C-reactive protein (151 mg/L vs 243 mg/L, P = 0.0001), and tubo-ovarian abscess diameter (6.0 cm vs 8.0 cm, P = 0.0001). These parameters were used to create a risk prediction score. A score of four or more was predictive of requiring surgical/radiological intervention of tubo-ovarian abscess (P < 0.001). The score had a sensitivity of 69% and a specificity of 88%, with area under the curve (AUC) = 0.859. CONCLUSION: Currently, there is no guidance for clinicians on when to operate on a tubo-ovarian abscess. Our prediction score is simple, using only three easily obtained clinical characteristics.