NCT01977079

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 .

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

2.6 years

First QC Date

October 24, 2013

Last Update Submit

November 14, 2025

Conditions

PregnancyPremature Delivery

Keywords

pregnancypremature birthprocalcitonin

Outcome Measures

Primary Outcomes (1)

  • procalcitonin rate

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

    up to 48 hours

Study Arms (2)

Premature birth

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.

Other: procalcitonin

Not premature birth

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.

Other: procalcitonin

Interventions

procalcitoninOTHER
Not premature birthPremature birth

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier départemental Vendée

La Roche-sur-Yon, 85925, France

Location

Related Publications (1)

  • 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.

    PMID: 29514604RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Procalcitonin

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

CalcitoninPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProtein PrecursorsProteins

Study Officials

  • Guillaume DUCARME, PH

    Centre hospitalier départemental Vendée

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 6, 2013

Study Start

December 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

FR(1)