Procalcitonin and Threatened Premature Delivery

Pregnancy Clinical Trial

— MAPPRO  

Official title:

Procalcitonin and Threatened Premature Delivery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01977079
• Other study ID #: CHD061-13
• Status: Terminated
• Phase: N/A
• First received: October 24, 2013
• Last updated: January 10, 2017
• Start date: December 2013
• Est. completion date: July 2016

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 131
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pregnancy
• Premature Birth
• Premature Delivery

Intervention

Other:
• procalcitonin

Locations

Country	Name	City	State
France	Centre hospitalier départemental Vendée	La Roche sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	procalcitonin rate	Estimate serum procalcitonin according to premature or not in patients hospitalized for preterm labor.	up to 48 hours	No