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Clinical Trials/NCT03123926
NCT03123926
Unknown
Not Applicable

Spontaneous Preterm Birth Marker Test (SPBMT): Preterm Prediction Prospective Study

Sprim Advanced Life Sciences1 site in 1 country600 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Delivery
Sponsor
Sprim Advanced Life Sciences
Enrollment
600
Locations
1
Primary Endpoint
Lipid analysis (serum and DBS)
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
December 2018
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Sprim Advanced Life Sciences
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Lipid analysis (serum and DBS)

Time Frame: 6-12 months

Lipid profiles of preterm birth compared to term birth.

Cervical length

Time Frame: 6-12 months

Cervical length \<15, 20, 25 mm

Biomarkers (serum)

Time Frame: 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.

Study Sites (1)

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