Overview

This trial is active, not recruiting.

Conditions pregnancy, premature delivery
Treatment procalcitonin
Sponsor Centre Hospitalier Departemental Vendee
Start date December 2013
End date December 2016
Trial size 131 participants
Trial identifier NCT01977079, CHD061-13

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 .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
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.
procalcitonin
(Other)
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.
procalcitonin

Primary Outcomes

Measure
procalcitonin rate
time frame: up to 48 hours

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Procalcitonin and Threatened Premature Delivery
Principal investigator Guillaume DUCARME, PH
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Departemental Vendee.