Part 1 of 2: When a pregnancy fails early: EPF overdiagnosis can cause harm, so 100% specificity is the goal

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Authors: Lauren Hibler Carlos, Olga Grechukhina and Anna K. Sfakianaki
Date: Apr. 2017
From: Contemporary OB/GYN(Vol. 62, Issue 4)
Publisher: Intellisphere, LLC
Document Type: Medical condition overview; Report
Length: 1,872 words

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From the start, pregnancy poses significant risk to a woman's health, and differentiating normal from abnormal gestation may be challenging for a clinician. The time from a positive urine pregnancy test to a confirmed viable pregnancy can be a few weeks, during which time there can be cramping, spotting, and lack of early pregnancy signs, causing patient anxiety.

The main goal for the clinician is to confirm the location and viability of the pregnancy. Diagnosing normal intrauterine, abnormal intrauterine, or abnormally located pregnancy may be complicated and is integral for management of pregnancy. Certain conditions (eg, ectopic or molar pregnancy) can not only fail to result in a live birth but also impose significant maternal morbidity and mortality unless treated promptly. The term early pregnancy loss or failure (EPF) refers to a nonviable intrauterine pregnancy with either an empty gestational sac or a gestational sac containing an embryo or fetus without heart activity within the first 12 6/7 weeks of gestation. (1) At the same time premature assumption of the non-viability of a pregnancy can result in overdiagnosis of EPF and irreversible treatment measures of very early but potentially viable pregnancies. Since falsely diagnosing a pregnancy as failed carries potentially more harmful consequences than delay in diagnosing a failed pregnancy, the specificity goal for the criteria for diagnosis of non-viability is 100%. (2) Formation of this goal in the context of several large multicenter studies necessitated challenging the prior diagnostic cutoffs and timelines. The consequence was a recent change in guidelines for diagnosis of EPF, which made the criteria more strict and allowed for longer waiting time prior to making the final determination of nonviability. (3,4) Here we review the guidelines and literature on early pregnancy diagnosis (up to 12 6/7 weeks' gestation), localization, and identification of viability. Management, recovery, and recurrent loss will be covered in part 2 of this article, in the May issue.

Pregnancy diagnosis

In most cases, a pregnancy diagnosis is made with a positive pregnancy test | (urine or blood) in a reproductiveage women. This may be done when a woman is anticipating a pregnancy or she develops normal pregnancy-related symptoms (such as amenorrhea, nausea and vomiting, and breast tenderness) or abnormal symptoms (unusual vaginal bleeding, back or lower abdominal pain) or even signs of clinical instability (life-threatening vaginal bleeding, syncopal episode, etc.).

Human chorionic gonadotropin

The pregnancy test in current use is based on detection of human chorionic gonadotropin (hCG) in a woman's urine or blood. hCG is a 237 amino acid glycoprotein hormone produced largely by syncytiotrophoblast cells and composed of alpha and beta subunits. Its main function is to stimulate progesterone production by the corpus luteum until approximately 14 weeks' gestation. In normal singleton pregnancy, hCG starts to rise as early as 6-12 days after ovulation and reaches its peak...

Source Citation

Source Citation
Carlos, Lauren Hibler, et al. "Part 1 of 2: When a pregnancy fails early: EPF overdiagnosis can cause harm, so 100% specificity is the goal." Contemporary OB/GYN, vol. 62, no. 4, Apr. 2017, pp. 22+. Accessed 27 Jan. 2022.

Gale Document Number: GALE|A491848052