Spontaneous Preterm Birth Marker Test

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

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.

Study Overview

• Status: Unknown
• Conditions: Preterm Delivery

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• Philippines
  • Brgy Malaya
    • Quezon, Brgy Malaya, Philippines
      • Recruiting
      • The Perinatal Association of the Philippines
      • Contact: Jenny Rose Rodaje

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Estimated 600 symptomatic women aged ≥ 18 years with pregnancy at 24 to 28 weeks of gestation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sprim Advanced Life Sciences
• Collaborators: BABYNOSTICS
• Investigators: Principal Investigator: Mariano Diosdado V., MD, MD

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: biomarkers; lipids; spontaneous preterm birth
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: BAB-0316

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No