Declaring a gestation nonviable: when 99% certainty is not enough

Barnhart, Kurt T.; Senapati, Suneeta; Sammel, Mary D.

doi:10.1016/j.ajog.2020.10.016

Cited by 5 publications

(4 citation statements)

References 6 publications

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“…2,3 However, a rise below these thresholds, which are based on probabilistic models using serial hCG measurements, does not define nonviability. 21 A live birth has been noted with hCG increase as low as 35% over 48 hours. 22 A decline in initial hCG values before a viable pregnancy was diagnosed has been noted in 3 women who conceived with IVF.…”

Section: Discussionmentioning

confidence: 99%

“…The American College of Obstetricians and Gynecologists and NICE defines an increase of hCG levels of more than 49% (for initial values <1500 mIU/mL) and more than 63% over 48 hours as potentially viable, respectively . However, a rise below these thresholds, which are based on probabilistic models using serial hCG measurements, does not define nonviability . A live birth has been noted with hCG increase as low as 35% over 48 hours …”

Section: Discussionmentioning

confidence: 99%

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Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location

Barnhart

Hansen

Stephenson

et al. 2021

JAMA

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IMPORTANCEWomen with an early nonviable pregnancy of unknown location are at high risk of ectopic pregnancy and its inherent morbidity and mortality. Successful and timely resolution of the gestation, while minimizing unscheduled interventions, are important priorities.OBJECTIVE To determine if active management is more effective in achieving pregnancy resolution than expectant management and whether the use of empirical methotrexate is noninferior to uterine evacuation followed by methotrexate if needed. DESIGN, SETTING, AND PARTICIPANTS This multicenter randomized clinical trial recruited 255 hemodynamically stable women with a diagnosed persisting pregnancy of unknown location between July 25, 2014, and June 4, 2019, in 12 medical centers in the United States (final follow up, August 19, 2019).INTERVENTIONS Eligible patients were randomized in a 1:1:1 ratio to expectant management (n = 86), active management with uterine evacuation followed by methotrexate if needed (n = 87), or active management with empirical methotrexate using a 2-dose protocol (n = 82). MAIN OUTCOMES AND MEASURESThe primary outcome was successful resolution of the pregnancy without change from initial strategy. The primary hypothesis tested for superiority of the active groups combined vs expectant management, and a secondary hypothesis tested for noninferiority of empirical methotrexate compared with uterine evacuation with methotrexate as needed using a noninferiority margin of −12%. RESULTS Among 255 patients who were randomized (median age, 31 years; interquartile range, 27-36 years), 253 (99.2%) completed the trial. Ninety-nine patients (39%) declined their randomized allocation (26.7% declined expectant management, 48.3% declined uterine evacuation, and 41.5% declined empirical methotrexate) and crossed over to a different group. Compared with patients randomized to receive expectant management (n = 86), women randomized to receive active management (n = 169) were significantly more likely to experience successful pregnancy resolution without change in their initial management strategy (51.5% vs 36.0%; difference, 15.4% [95% CI, 2.8% to 28.1%]; rate ratio, 1.43 [95% CI, 1.04 to 1.96]). Among active management strategies, empirical methotrexate was noninferior to uterine evacuation followed by methotrexate if needed with regard to successful pregnancy resolution without change in management strategy (54.9% vs 48.3%; difference, 6.6% [1-sided 97.5% CI, −8.4% to ϱ]). The most common adverse event was vaginal bleeding for all of the 3 management groups (44.2%-52.9%).CONCLUSIONS AND RELEVANCE Among patients with a persisting pregnancy of unknown location, patients randomized to receive active management, compared with those randomized to receive expectant management, more frequently achieved successful pregnancy resolution without change from the initial management strategy. The substantial crossover between groups should be considered when interpreting the results.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location

Barnhart

Hansen

Stephenson

et al. 2021

JAMA

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“…Interestingly, when the aforementioned β -hCG references were applied to a group of 1,249 patients considered at risk of EP, a minimal rise in hCG levels of 35% in 2 days (the lower bound from a 99.9% confidence interval for the rise of β -hCG among IUP) was the best to characterize a potentially viable gestation, and further minimize potential interruption of a desired pregnancy [ 10 ]. Although 99% of normal gestations will have at least this rise in hCG, this should not be interpreted as a threshold for viability and the diagnosis of a nonviable pregnancy should not be solely based on early β -hCG changes [ 11 ]. Table 2 summarizes the minimal expected increase in β -hCG levels in normal IUPs.…”

Section: Hcg: Biochemical and Laboratory Issuesmentioning

confidence: 99%

β‐Human Chorionic Gonadotropin Dynamics in Early Gestational Events: A Practical and Updated Reappraisal

Larraín,

Caradeux

2024

Obstetrics and Gynecology International

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In the last decade, the widespread use of transvaginal ultrasound and the availability of highly specific serum assays of human chorionic gonadotropin (hCG) have become mainstays in the evaluation of early pregnancy. These tests have revolutionized the management of pregnancies of unknown location and markedly reduced the morbidity and mortality associated with the misdiagnosis of ectopic pregnancy. However, despite several advances, their misuse and misinterpretations are still common, leading to an increased use of healthcare resources, patient misinformation, and anxiety. This narrative review aims to succinctly summarize the β-hCG dynamics in early gestation and provide general gynecologists a practical approach to patients with first-trimester symptomatic pregnancy.

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“…Indeed, incorrect use of these rates as a threshold can result in misdiagnosis of a viable intrauterine pregnancy. 9,12–14 However, in limiting the studied population only to individuals with later confirmed viable intrauterine pregnancies, the determined bounds of hCG rise do not inform the tradeoff rates of missed diagnoses of abnormal pregnancies such as early pregnancy loss and ectopic pregnancy. Although ectopic pregnancies represent only 2% of all pregnancies, they are the most common cause of maternal death in the first trimester.…”

mentioning

confidence: 99%

Evaluation of a New Model for Human Chorionic Gonadotropin Rise in Pregnancies of Unknown Viability

Bollig

Finlinson

Barnhart

et al. 2023

Obstetrics &Amp; Gynecology

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Declaring a gestation nonviable: when 99% certainty is not enough

Abstract: The authors report no conflict of interest.hCG, human chorionic gonadotropin.

Cited by 5 publications

References 6 publications

Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location

Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location

β‐Human Chorionic Gonadotropin Dynamics in Early Gestational Events: A Practical and Updated Reappraisal

Evaluation of a New Model for Human Chorionic Gonadotropin Rise in Pregnancies of Unknown Viability

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