New Biomarkers Associated With the Risk of Premature Delivery.

NCT04067908 | Completed

• 1 other identifier: CHUBX 2010/19
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality. This study aims to estimate the prognostic value of new biomarkers (proteomic markers) on the occurrence of preterm birth.

Conditions

Premature Delivery

Keywords

Biological markers

Outcome Measures

Primary Outcomes (1)

• Premature delivery yes/no

  Premature labor is defined as a pregnancy duration of less than 37 weeks. For this study, cases of interest are : premature labor before 33 amenorrhea weeks + 6 days.

  Premature delivery before 33 amenorrhea weeks + 6 days

Study Arms (1)

woman giving birth prematurely

EXPERIMENTAL

Proteome: by liquid chromatography coupled with tandem mass spectrometry. Fibronectin: by vaginal sampling. Ultrasound of the cervix. Cytokines: ELISA kit of a panel of several cytokines.

Other: 2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling

Interventions

2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling OTHER

The samples taken during this study are taken at the same time as those taken in routine during the diagnosis of threat of premature labor. There are added 2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling.

woman giving birth prematurely

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Woman during childbirth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women over 18 years of age
• Term from 22 to 33 and 6 amenorrhea weeks
• Single or twin pregnancy
• Emergency consultant, in participating centers, for a threat of premature labor defined by:
• Uterine contractions greater than or equal to 3 in 30 minutes Clinical modification of the cervix Ultrasound collar less than 25 mm
• Free, informed and written consent, dated and signed by the patient and the investigator before any investigation required by the research.
• Patient affiliated to a Social Security scheme.

You may not qualify if:

• Premature rupture of membranes
• Placenta previa
• Vaginal haemorrhage at the time of sampling
• Uterine malformation
• Strapping, open bite
• History of strapping and or open bite
• Conization
• Fetal malformation
• Associated vasorenal pathology
• Sexual intercourse less than 24h
• Gynecological examination less than 48h
• Vaginal treatment in progress
• Polyhydramnios
• Transfused-transfused syndrome
• Twin Anemia Polycythemia syndrome

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dominique DALLAY, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: June 7, 2011
• Primary Completion: December 28, 2013
• Study Completion: December 28, 2013
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share