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Procalcitonin and Threatened Premature Delivery (MAPPRO)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01977079
First Posted: November 6, 2013
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee
  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: None (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 ]
    Estimate serum procalcitonin according to premature or not in patients hospitalized for preterm labor.


Enrollment: 131
Study Start Date: December 2013
Study Completion Date: July 2016
Primary Completion Date: July 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977079


Locations
France
Centre hospitalier départemental Vendée
La Roche sur Yon, France, 85925
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
Principal Investigator: Guillaume DUCARME, PH Centre hospitalier départemental Vendée
  More Information

Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT01977079     History of Changes
Other Study ID Numbers: CHD061-13
First Submitted: October 24, 2013
First Posted: November 6, 2013
Last Update Posted: January 11, 2017
Last Verified: January 2017

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs