Accuracy of single progesterone test to predict early pregnancy outcome in women with pain or bleeding: meta-analysis of cohort studies

Abstract

Objective To determine the accuracy with which a single progesterone measurement in early pregnancy discriminates between viable and non-viable pregnancy.Design Systematic review and meta-analysis of diagnostic accuracy studies.Data sources Medline, Embase, CINAHL, Web of Science, ProQuest, Conference Proceedings Citation Index, and the Cochrane Library from inception until April 2012, plus reference lists of relevant studies.Study selection Studies were selected on the basis of participants (women with spontaneous pregnancy of less than 14 weeks of gestation); test (single serum progesterone measurement); outcome (viable intrauterine pregnancy, miscarriage, or ectopic pregnancy) diagnosed on the basis of combinations of pregnancy test, ultrasound scan, laparoscopy, and histological examination; design (cohort studies of test accuracy); and sufficient data being reported.Results 26 cohort studies, including 9436 pregnant women, were included, consisting of 7 studies in women with symptoms and inconclusive ultrasound assessment and 19 studies in women with symptoms alone. Among women with symptoms and inconclusive ultrasound assessments, the progesterone test (5 studies with 1998 participants and cut-off values from 3.2 to 6 ng/mL) predicted a non-viable pregnancy with pooled sensitivity of 74.6% (95% confidence interval 50.6% to 89.4%), specificity of 98.4% (90.9% to 99.7%), positive likelihood ratio of 45 (7.1 to 289), and negative likelihood ratio of 0.26 (0.12 to 0.57). The median prevalence of a non-viable pregnancy was 73.2%, and the probability of a non-viable pregnancy was raised to 99.2% if the progesterone was low. For women with symptoms alone, the progesterone test had a higher specificity when a threshold of 10 ng/mL was used (9 studies with 4689 participants) and predicted a non-viable pregnancy with pooled sensitivity of 66.5% (53.6% to 77.4%), specificity of 96.3% (91.1% to 98.5%), positive likelihood ratio of 18 (7.2 to 45), and negative likelihood ratio of 0.35 (0.24 to 0.50). The probability of a non-viable pregnancy was raised from 62.9% to 96.8%. ConclusionA single progesterone measurement for women in early pregnancy presenting with bleeding or pain and inconclusive ultrasound assessments can rule out a viable pregnancy. IntroductionVaginal bleeding and abdominal pain are the most common causes of consultation in early pregnancy; 30% of women will experience pain or bleeding in their first trimester.1 These symptoms lead to anxiety and can be the first signs of a possible miscarriage or an ectopic pregnancy. Miscarriage occurs in 10-20% of all recognised pregnancies, and the prevalence of ectopic pregnancies in the United Kingdom is 1.6%, which is raised to 3% in women with symptoms.2-4 Most women seeking medical advice have a transvaginal ultrasound scan to confirm a viable pregnancy, a miscarriage, or an ectopic pregnancy. However, even with expert use of transvaginal ultrasound, confirming if a pregnancy is intrauterine or extrauterine may not be possible in 8-31% of cases at the ...

Role of single serum progesterone assay in threatened abortion as a predictor of viable pregnancy

“…[18] Verhaegen J et al (2012) also concluded that a single progesterone measurement for women in early pregnancy presenting with bleeding or pain and inconclusive ultrasound assessments can rule out a viable pregnancy. [19] In a study done by Abdelazim IA et al(2013), the mean serum progesterone of the studied population was significantly higher in the viable pregnancy group (46.5±7.4 ng/mL) compared to non-viable pregnancy group (9.9±4.8 ng/mL; p<0.05). [20] In my study, progesterone supplements (Oral micronized progesterone twice daily) were given to all the cases, irrespective of their serum progesterone levels, as per the institute protocol, however nothing could be proven as regards to decreased rate of abortions.…”

The Accuracy of Single Progesterone, Single β-hCG, and Their Combination Measurement in Predicting Early Miscarriage: A Prospective Study in Outpatient Setting

“…It is advisable to combine it with the other tests [9]. Current meta-analysis supported the paradigm shift toward benefit of serum progesterone level alone [7]. Al Jufairy also reported that lower level of progesterone could predict not only miscarriage but also ectopic pregnancy [10].…”

“…Also, we had limited data regarding other potentials confounders being reported elsewhere (e.g. chromosomal abnormality, quantitative data about maternal complaints of bleeding and pain, paternal age, and maternal consumption of potential related compounds) [7,14,21,22]. However, our study performed in outpatient setting where most of Indonesian women seek medical advice for their pregnancy for the first time based on author's knowledge.…”

“…Although ultrasonography had best diagnostic ability, it may give non conclusive result if gestational age is still too young [7]. A suboptimal rise of serum -hCG (lower than 66% with two days interval serial measurement) was previously considered having a good prognostic accuracy.…”

“…Elson et al and Abdelazim et al found progesterone as a potential predictor of successful pregnancy [5,6]. Recent meta-analysis also support a single measurement of progesterone to predict a viable pregnancy outcomes [7]. Besides, combination of serum progesterone with serumhCG increased the accuracy for predicting the outcome of threatened miscarriage [8].…”