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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
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Premature Delivery focused on measuring Biological markers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    August 22, 2019
    Last Updated
    August 26, 2019
    Sponsor
    University Hospital, Bordeaux
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    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

    Learn more about this trial

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