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Procalcitonin and Threatened Premature Delivery (MAPPRO)

Primary Purpose

Pregnancy, Premature Delivery

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
procalcitonin
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pregnancy focused on measuring pregnancy, premature birth, procalcitonin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre hospitalier départemental Vendée

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Premature birth

Not premature birth

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

procalcitonin rate
Estimate serum procalcitonin according to premature or not in patients hospitalized for preterm labor.

Secondary Outcome Measures

Full Information

First Posted
October 24, 2013
Last Updated
January 10, 2017
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT01977079
Brief Title
Procalcitonin and Threatened Premature Delivery
Acronym
MAPPRO
Official Title
Procalcitonin and Threatened Premature Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Premature Delivery
Keywords
pregnancy, premature birth, procalcitonin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Premature birth
Arm Type
Other
Arm Description
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.
Arm Title
Not premature birth
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
procalcitonin
Primary Outcome Measure Information:
Title
procalcitonin rate
Description
Estimate serum procalcitonin according to premature or not in patients hospitalized for preterm labor.
Time Frame
up to 48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume DUCARME, PH
Organizational Affiliation
Centre hospitalier départemental Vendée
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier départemental Vendée
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29514604
Citation
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.
Results Reference
derived

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Procalcitonin and Threatened Premature Delivery

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