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Research

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

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e6077 (Published 27 September 2012) Cite this as: BMJ 2012;345:e6077
  1. Jorine Verhaegen, medical student1,
  2. Ioannis D Gallos, specialist registrar2,
  3. Norah M van Mello, research fellow3,
  4. Mohamed Abdel-Aziz, consultant2,
  5. Yemisi Takwoingi, research fellow3,
  6. Hoda Harb, research fellow2,
  7. Jonathan J Deeks, professor3,
  8. Ben W J Mol, professor1,
  9. Arri Coomarasamy, professor2
  1. 1Department of Obstetrics and Gynaecology, Academic Medical Centre University of Amsterdam, Amsterdam, Netherlands
  2. 2School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
  3. 3Public Health, Epidemiology and Biostatistics, School of Health and Population Sciences, College of Medical and Dental Sciences, University of Birmingham
  1. Correspondence to: I D Gallos, Nuffield Department of Obstetrics and Gynaecology, University of Oxford, Oxford Radcliffe Hospitals NHS Trust, The Women’s Centre, Oxford OX3 9DU, UK ioannis.gallos{at}nhs.net
  • Accepted 28 August 2012

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%.

Conclusion A single progesterone measurement for women in early pregnancy presenting with bleeding or pain and inconclusive ultrasound assessments can rule out a viable pregnancy.

Footnotes

  • Contributors: IDG and MA-A had the idea for the systematic review, did the literature search, and screened eligible abstracts and databases. JV and NM did the full manuscript evaluation and study selection. JV, IDG, NMvM, HH, and MA-A extracted the data. YT and JJD analysed the data. IDG, JV, NMvM, and YT interpreted the data. JV and NMvM assessed the quality of the studies. JV drafted the first version of the manuscript, and IDG drafted all the subsequent versions and the final manuscript. BWJM, JJD, and AC gave critical input. AC is the guarantor.

  • Funding: None.

  • Competing interests: All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from institution for the submitted work; no relationships with any institution that might have an interest in the submitted work in the previous three years; and no non-financial interests that may be relevant to the submitted work.

  • Ethical approval: Not needed.

  • Data sharing: No additional data available.

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