Spontaneous Preterm Birth Marker Test

• Conditions: Preterm Delivery

• Registration Number: NCT03123926
• Lead Sponsor: Sprim Advanced Life Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-02-20
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Study First Posted: 2017-04-21
• Last Update Posted: 2017-04-21
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lipid analysis (serum and DBS)	6-12 months	Lipid profiles of preterm birth compared to term birth.
Cervical length	6-12 months	Cervical length \<15, 20, 25 mm
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.

Trial Locations

Locations (1)

The Perinatal Association of the Philippines; 🇵🇭 Quezon, Brgy Malaya, Philippines