Procalcitonin and Threatened Premature Delivery

NCT ID: NCT01977079

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-07-31

Brief Summary

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Among all patients hospitalized for Threatened Premature Delivery (TPD), the rate of premature birth (PB) before 37 weeks is about 42%, which reflects the inability to accurately identify patients at high risk of PB. Currently, no clinical or biological marker is recognized as the most reliable in predicting the real risk of AP in case of MAP.

The purpose of this study is to improve the knowledge of predictors of preterm delivery compared with conventional blood markers by estimating serum procalcitonin according to premature delivery or not in patients hospitalized for preterm labor .

Detailed Description

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Conditions

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Pregnancy Premature Delivery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Premature birth

At the end of the study patients will be divided into two groups: "Premature delivery" versus "No premature delivery." Prematurity is defined as a birth before 37.

In each group, the procalcitonin rate be estimated with a confidence interval of 95% and compared from a logistic regression.

Group Type OTHER

procalcitonin

Intervention Type OTHER

Not premature birth

At the end of the study patients will be divided into two groups: "Premature delivery" versus "No premature delivery." Prematurity is defined as a birth before 37.

In each group, the procalcitonin rate be estimated with a confidence interval of 95% and compared from a logistic regression.

Group Type OTHER

procalcitonin

Intervention Type OTHER

Interventions

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procalcitonin

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age \> 18 year
* Ongoing pregnancy with a start date of pregnancy known and confirmed by an ultrasound of the 1st Quarter performed between 10 and 14 weeks with a measurement of the crown-rump length
* hospitalization for preterm labor between 24 and 36 weeks of gestation
* Intact membranes,
* not opposed to participate in the study

Exclusion Criteria

* Pregnancy uncertain term (no early ultrasound)
* Pregnancy combining a condition that can interfere with the assays performed,
* Uterine malformation known
* Multiple pregnancy,
* Premature rupture of membranes,
* Chrorio-amnionitis,
* Fetal malformation known
* Strapping
* GB\> 15000 and CRP\> 10 mg / L,
* No affiliation to a social security scheme.
* Woman with a measure of legal protection
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume DUCARME, PH

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier départemental Vendée

Locations

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Centre hospitalier départemental Vendée

La Roche-sur-Yon, , France

Site Status

Countries

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France

References

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Ducarme G, Desroys du Roure F, Le Thuaut A, Grange J, Vital M, Dimet J. Efficacy of serum procalcitonin to predict spontaneous preterm birth in women with threatened preterm labour: a prospective observational study. BMC Pregnancy Childbirth. 2018 Mar 7;18(1):65. doi: 10.1186/s12884-018-1696-2.

Reference Type RESULT
PMID: 29514604 (View on PubMed)

Other Identifiers

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CHD061-13

Identifier Type: -

Identifier Source: org_study_id

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