Spontaneous Preterm Birth Marker Test

Preterm Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03123926
• Other study ID #: BAB-0316
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2017
• Last updated: April 18, 2017
• Start date: November 2016
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: Sprim Advanced Life Sciences
• Contact: Jillian De Leon
• Email: jillian.deleon[@]sprim.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Delivery

Locations

Country	Name	City	State
Philippines	The Perinatal Association of the Philippines	Quezon	Brgy Malaya

Sponsors (2)

Lead Sponsor	Collaborator
Sprim Advanced Life Sciences	BABYNOSTICS

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical length	Cervical length <15, 20, 25 mm	6-12 months
Primary	Biomarkers (serum)	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.	6-12 months
Primary	Lipid analysis (serum and DBS)	Lipid profiles of preterm birth compared to term birth.	6-12 months