Spontaneous Preterm Birth Marker Test

NCT03123926 | Unknown

• 1 other identifier: BAB-0316
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Delivery

Keywords

spontaneous preterm birth; lipids; biomarkers

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnancy women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Pregnancy women aged ≥ 18 years with pregnancy at 24 to 28 weeks of gestation.

You may not qualify if:

• Subjects with any conditions or diseases that investigator considers it is not appropriate to enter the study.

Sponsors & Collaborators

• Sprim Advanced Life Sciences: lead
• BABYNOSTICS: collaborator

Study Sites (1)

The Perinatal Association of the Philippines

Quezon, Brgy Malaya, Philippines

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva, cervicovaginal fluid, serum and dried blood spot

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Mariano Diosdado V., MD

  MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jillian De Leon

CONTACT

jillian.deleon@sprim.com

Orawan Suitthimeathegorn

CONTACT

orawan.suitthimeathegorn@sprim.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: April 21, 2017
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: April 21, 2017

Record last verified: 2017-04

Locations

PH (1)