New Biomarkers Associated With the Risk of Premature Delivery. (PROTEOMAP)
Primary Purpose
Premature Delivery
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling
Sponsored by

About this trial
This is an interventional basic science trial for Premature Delivery focused on measuring Biological markers
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
woman giving birth prematurely
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04067908
First Posted
August 22, 2019
Last Updated
August 26, 2019
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04067908
Brief Title
New Biomarkers Associated With the Risk of Premature Delivery.
Acronym
PROTEOMAP
Official Title
Study of New Biomarkers Associated With the Risk of Premature Delivery During Spontaneous Work With Intact Membranes Before 37 Weeks of Amenorrhea.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 7, 2011 (Actual)
Primary Completion Date
December 28, 2013 (Actual)
Study Completion Date
December 28, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Delivery
Keywords
Biological markers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
woman giving birth prematurely
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Premature delivery yes/no
Description
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.
Time Frame
Premature delivery before 33 amenorrhea weeks + 6 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Woman during childbirth
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique DALLAY, Pr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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New Biomarkers Associated With the Risk of Premature Delivery.
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