The value of a vaginal sample for detecting PAMG-1 (Partosure®) in women with a threatened preterm delivery (the MAPOSURE Study): protocol for a multicenter prospective study Article Swipe
Emilie Marie
,
Guillaume Ducarme
,
Marion Boivin
,
Virginie Badon
,
Hélène Pelerin
,
Aurélie Le Thuaut
,
Zeineb Lamoureux
,
Valéry-Pierre Riche
,
Norbert Winer
,
Thibault Thubert
,
Vincent Dochez
·
YOU?
·
· 2020
· Open Access
·
· DOI: https://doi.org/10.1186/s12884-020-03129-x
YOU?
·
· 2020
· Open Access
·
· DOI: https://doi.org/10.1186/s12884-020-03129-x
Background Threatened preterm delivery (TPD) is the leading cause of inpatient admissions during pregnancy. The ability to predict the risk of imminent preterm delivery is thus a major priority in obstetrics. The aim of our study is to assess the diagnostic performance of the test to detect the placental alpha microglobulin 1 (PAMG-1) for the prediction of delivery within 7 days in women with TPD. Methods This is a prospective multicenter diagnostic study. Inclusion criteria are singleton pregnancy, gestational age between 24 + 0 and 33 + 6 weeks inclusive, cervical measurement 25 mm or less assessed by transvaginal ultrasound (with or without uterine contractions), clinically intact membranes and cervical dilatation < 3 cm assessed by digital examination. According to the current protocol, when a women presents with TPD and the diagnosis is confirmed by transvaginal ultrasound, a vaginal sample to test for genital infection is performed. At the same time, the midwife will perform the PartoSure® test. To perform this analysis, a sample of cervicovaginal secretions is taken with the vaginal swab furnished in the test kit. The primary outcome is the specificity of the PartoSure® test of women who gave birth more than 7 days after their hospitalization for TPD. The secondary outcomes are the sensitivity, PPV, and NPV of the Partosure® test and the factors associated with false positives (with a univariate logistic regression model). Starting with the hypothesis of an anticipated specificity of 89%, if we want to estimate this specificity with a confidence interval of ± 5%, we will require 151 women who do not give birth within 7 days. We therefore decided to include 400 women over a period of two years to have a larger number of events (deliveries within 7 days). Discussion The different tests already used such as fetal fibronectin and phIGFBP-1, are not sufficiently relevant to recommend their use in daily practice. The different studies of PAMG-1 described above thus provide support for the use of this substance, tested by PartoSure®. Nonetheless, other larger studies are necessary to validate its use in daily practice and our study could answer this question. Trial registration NCT03401255 (January 15, 2018)
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1186/s12884-020-03129-x
- https://bmcpregnancychildbirth.biomedcentral.com/track/pdf/10.1186/s12884-020-03129-x
- OA Status
- gold
- Cited By
- 3
- References
- 33
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3047489196
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W3047489196Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1186/s12884-020-03129-xDigital Object Identifier
- Title
-
The value of a vaginal sample for detecting PAMG-1 (Partosure®) in women with a threatened preterm delivery (the MAPOSURE Study): protocol for a multicenter prospective studyWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2020Year of publication
- Publication date
-
2020-08-03Full publication date if available
- Authors
-
Emilie Marie, Guillaume Ducarme, Marion Boivin, Virginie Badon, Hélène Pelerin, Aurélie Le Thuaut, Zeineb Lamoureux, Valéry-Pierre Riche, Norbert Winer, Thibault Thubert, Vincent DochezList of authors in order
- Landing page
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https://doi.org/10.1186/s12884-020-03129-xPublisher landing page
- PDF URL
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https://bmcpregnancychildbirth.biomedcentral.com/track/pdf/10.1186/s12884-020-03129-xDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
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https://bmcpregnancychildbirth.biomedcentral.com/track/pdf/10.1186/s12884-020-03129-xDirect OA link when available
- Concepts
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Medicine, Obstetrics, Prospective cohort study, Pregnancy, Gynecology, Confidence interval, Logistic regression, Gestational age, Vagina, Reproductive medicine, Surgery, Internal medicine, Genetics, BiologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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3Total citation count in OpenAlex
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2025: 1, 2021: 2Per-year citation counts (last 5 years)
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33Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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