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Spontaneous Preterm Birth Marker Test

Sponsor
Sprim Advanced Life Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT03123926
Collaborator
BABYNOSTICS (Other)
600
Enrollment
1
Location
25
Duration (Months)
24
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The prediction of preterm birth is beneficial because it initiates early treatment to minimize risk. It defines a population at risk to provide particular treatment and may lead us to a better understanding the mechanisms of preterm birth. The understanding of the mechanisms and etiology consequently leads to the possibility of early intervention and effective management aiming at preventing preterm birth. Five most common interventions for preventing and treating preterm birth are antibiotics, cervical cerclage, bed rest, progesterone, and tocolytic therapy. However, there are insufficient evidence showing the efficacy of cerclage and bed rest; antibiotics may only delay but not prevent the preterm birth; the use of certain tocolytics needs to be considered against the possible adverse effects. The early detection of pregnant women with high risk for preterm delivery would be the ideal solution to prevent preterm birth. However, to date, there is inadequate literature and little knowledge of diagnosis, treatment, prevention and prediction of preterm birth.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Spontaneous Preterm Birth Marker Test (SPBMT): Preterm Prediction Prospective Study
    Study Start Date :
    Nov 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2017
    Anticipated Study Completion Date :
    Dec 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Cervical length [6-12 months]

      Cervical length <15, 20, 25 mm

    2. Biomarkers (serum) [6-12 months]

      subjects with feral fibronectin ≥50 ng/mL, >10 mg/L of cervical phIGFBP1; elevated Interleukin-6 as compared to term birth; significantly present of other biomarkers.

    3. Lipid analysis (serum and DBS) [6-12 months]

      Lipid profiles of preterm birth compared to term birth.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pregnancy women aged ≥ 18 years with pregnancy at 24 to 28 weeks of gestation.
    Exclusion Criteria:
    • Subjects with any conditions or diseases that investigator considers it is not appropriate to enter the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Perinatal Association of the Philippines Quezon Brgy Malaya Philippines

    Sponsors and Collaborators

    • Sprim Advanced Life Sciences
    • BABYNOSTICS

    Investigators

    • Principal Investigator: Mariano Diosdado V., MD, MD

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sprim Advanced Life Sciences
    ClinicalTrials.gov Identifier:
    NCT03123926
    Other Study ID Numbers:
    • BAB-0316
    First Posted:
    Apr 21, 2017
    Last Update Posted:
    Apr 21, 2017
    Last Verified:
    Apr 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sprim Advanced Life Sciences
    spontaneous preterm birth
    lipids
    biomarkers
    Additional relevant MeSH terms:
    Premature Birth

    Study Results

    No Results Posted as of Apr 21, 2017