Procalcitonin and Threatened Premature Delivery (MAPPRO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Centre Hospitalier Departemental Vendee
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier:
NCT01977079
First received: October 24, 2013
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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 .


Condition Intervention
Pregnancy
Premature Delivery
Other: procalcitonin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Procalcitonin and Threatened Premature Delivery

Further study details as provided by Centre Hospitalier Departemental Vendee:

Primary Outcome Measures:
  • procalcitonin rate [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]
    Estimate serum procalcitonin according to premature or not in patients hospitalized for preterm labor.


Estimated Enrollment: 200
Study Start Date: December 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other: procalcitonin
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.

Other: procalcitonin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977079

Locations
France
Centre hospitalier départemental Vendée Recruiting
La Roche sur Yon, France, 85925
Contact: Lucie AUZANNEAU       lucie.auzanneau@chd-vendee.fr   
Principal Investigator: Guillaume DUCARME, PH         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
Principal Investigator: Guillaume DUCARME, PH Centre hospitalier départemental Vendée
  More Information

No publications provided

Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT01977079     History of Changes
Other Study ID Numbers: CHD061-13
Study First Received: October 24, 2013
Last Updated: June 12, 2014
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by Centre Hospitalier Departemental Vendee:
pregnancy
premature birth
procalcitonin

Additional relevant MeSH terms:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 16, 2014