New Biomarkers Associated With the Risk of Premature Delivery. (PROTEOMAP)

Study of New Biomarkers Associated With the Risk of Premature Delivery During Spontaneous Work With Intact Membranes Before 37 Weeks of Amenorrhea.

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.

Study Overview

• Status: Completed
• Conditions: Premature Delivery
• Intervention / Treatment: Other: 2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling

Detailed Description

Despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality. With 7.2% of premature deliveries in France, threat of premature labor remains the leading cause of maternal transfer and hospitalization. In terms of mortality, morbidity and cost, the fight against prematurity remains a national priority in terms of public health.

The diagnosis of threat of premature labor at high risk of preterm labor is difficult and clinical and laboratory criteria often remain insufficient. Measurement of the cervix by endovaginal ultrasound lacks sensitivity and specificity. Among the biological criteria, only fibronectin, which has a good negative predictive value, is used in current practice. Despite the use of these two prognostic criteria, only 40% of hospitalized patients will give birth prematurely.

Recent advances in proteomics allow us to study complex proteomes and compare them. Preliminary studies already carried out have revealed families of proteins expressed differently in situations of work or premature delivery. We therefore hypothesize that the study of a woman's vaginal proteome with threat of premature labor may reveal new markers of preterm labor. These markers could help the clinician in its therapeutic management and thus reduce hospitalizations, better target patients requiring tocolytic treatment and optimize the use of corticosteroids. In addition, variations in the proteome may help to understand the physiopathological mechanisms of premature delivery, which are necessary for the development of effective therapeutics.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Fetoscopy during pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: woman giving birth prematurely; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Dominique DALLAY, Pr, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2011
• Primary Completion (Actual): December 28, 2013
• Study Completion (Actual): December 28, 2013

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Biological markers
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: CHUBX 2010/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No