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Performance of single serum progesterone in the evaluation of symptomatic first-trimester pregnant patients: a systematic review and meta-analysis

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Abstract

Objectives

Pain and bleeding complicate 30% of pregnancies, raising concerns for viability. The objective is to evaluate the diagnostic characteristics of a single serum progesterone level in assessing pregnancy viability among symptomatic patients.

Methods

We conducted a predefined literature search in MEDLINE, Embase (OVID), CINAHL and Cochrane databases for studies that enrolled patients in first trimester with miscarriage symptoms, measured progesterone and reported pregnancy viability, from inception to July 2020. We extracted data for 2 × 2 tables, progesterone threshold levels and viability. We obtained summary estimates of sensitivity, specificity, Diagnostic Odds Ratio (DOR), and predictive values at given prevalence rates.

Results

We identified 54 publications. There was a total of 15,878 patients enrolled, of whom 7864 patients (49.5%) were confirmed to have a viable pregnancy and 8014 patients (50.5%) were confirmed to have a non-viable pregnancy. The cut-off value of progesterone ranged from 3.2 to 25 ng/mL (20.034–79.5 nmol/L). We evaluated the performance of the following progesterone cut-off categories: < 6.3, 6.3–12.6, 12.7–19.9, and 20–25 ng/mL. To detect non-viable pregnancy, progesterone with cut-off < 6.3 ng/mL had sensitivity 73.1%, specificity 99.2% and DOR 322.0 (PPV 0.91, 0.97 and 0.99 at prevalences 0.1, 0.25, 0.5, respectively, indicating higher likelihood of non-viable pregnancy), and cut-off category 20–25 ng/mL had sensitivity 91.3%, specificity 75% and DOR 31.4 (NPV 0.99, 0.96 and 0.89 at the prevalences above indicating higher likelihood of viable pregnancy).

Conclusion

A single progesterone level provides a clinically useful prognostic information on pregnancy viability. More than nine out of ten patients with a level < 6.3 ng/mL (< 20.034 nmol/L) will be diagnosed with a non-viable pregnancy, and more than 90% of patients with a level ≥ 20–25 ng/mL (63.6–79.5 nmol/L) will have a viable pregnancy confirmed.

Résumé

Objectives

La douleur et les saignements compliquent 30% des grossesses, ce qui soulève des inquiétudes quant à la viabilité. L’objectif est d’évaluer les caractéristiques diagnostiques d’un seul taux sérique de progestérone dans l’évaluation de la viabilité de la grossesse chez les patientes symptomatiques.

Méthodes

Nous avons effectué une recherche littérature prédéfinie dans les bases de données MEDLINE, Embase (OVID), CINAHL et Cochrane pour des études qui ont recruté des patientes au cours du premier trimestre présentant des symptômes de fausse couche, mesuré la progestérone et signalé la viabilité de la grossesse, du début à juillet 2020. Nous avons extrait les données pour les tableaux 2 × 2, les niveaux de seuil de progestérone et la viabilité. Nous avons obtenu des estimations sommaires de la sensibilité, de la spécificité, du rapport de cotes diagnostiques (DOR) et des valeurs prédictives à des taux de prévalence donnés.

Résultats

On a identifié 54 publications. Il y avait un total de 15 878 patientes recrutées, dont 7864 patientes (49.5%) ont été confirmées comme ayant une grossesse viable et 8014 patientes (50,5%) ont été confirmées comme ayant une grossesse non viable. La valeur seuil de la progestérone variait de 3.2 – 25 ng/mL (20.034 – 79.5 nmol/L). Nous avons évalué les performances des catégories de seuil de progestérone suivantes: < 6.3, 6.3–12.6, 12.7–19.9 et 20–25 ng/mL. Pour détecter une grossesse non viable, la progestérone avec seuil < 6.3 ng/mL avait une sensibilité de 73.1%, une spécificité de 99.2% et une DOR 322.0 (PPV 0.91, 0.97 et 0.99 à des prévalences de 0.1, 0.25, 0.5 respectivement indiquant une probabilité plus élevée de grossesse non viable), et la catégorie de coupure 20–25 ng/mL avait une sensibilité de 91,3%, une spécificité de 75% et une DOR 31,4 (NPV 0.99, 0.96 et 0.89 aux prévalences ci-dessus indiquant une probabilité plus élevée de grossesse viable).

Conclusion

Un seul niveau de progestérone fournit une information pronostique cliniquement utile sur la viabilité de la grossesse. Plus de neuf patientes sur dix avec un niveau < 6.3 ng/mL (< 20.034 nmol/L) sera diagnostiqué de grossesse non viable, et plus de 90% des patientes ayant un niveau ≥ 20–25 ng/mL (63.6–79.5 nmol/L) auront une grossesse viable confirmée.

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Acknowledgements

We thank Mrs. Preeti Gupta for input with clinical guidelines.

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Author notes

  1. Bahareh Ghaedi and Wei Cheng have contributed equally to this work.

Authors and Affiliations

  1. Department of Clinical Epidemiology Program-Emergency Medicine, Clinical Epidemiology Unit, Ottawa Hospital Research Institute, ON, Ottawa, Canada

    Bahareh Ghaedi, Sara Ameri & Venkatesh Thiruganasambandamoorthy

  2. Yale School of Public Health, New Haven, USA

    Wei Cheng

  3. Royal College of Surgeons in Ireland, Dublin, Ireland

    Khadeer Abdulkarim

  4. Department of Emergency Medicine, University of Ottawa, Ottawa, ON, Canada

    Nicholas Costain, Ayesha Zia & Venkatesh Thiruganasambandamoorthy

  5. The Ottawa Hospital, Ottawa, ON, Canada

    Nicholas Costain, Ayesha Zia & Venkatesh Thiruganasambandamoorthy

  6. School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada

    Venkatesh Thiruganasambandamoorthy

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Contributions

BG and WC contributed equally to the systematic review and are joint first authors. VT, BG, and WC were the core team leading the systematic review. BG, SA, and KA identified and selected the studies. BG, WC, SA, KA, NC and AZ collected the data. VT and WC analyzed the data. BG, WC and VT drafted the manuscript. All authors approved the final version of the manuscript. VT is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

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Correspondence to Venkatesh Thiruganasambandamoorthy.

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PROSPERO 2020 CRD42020186508.

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Ghaedi, B., Cheng, W., Ameri, S. et al. Performance of single serum progesterone in the evaluation of symptomatic first-trimester pregnant patients: a systematic review and meta-analysis. Can J Emerg Med 24, 611–621 (2022). https://doi.org/10.1007/s43678-022-00332-x

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