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Spontaneous Preterm Birth Marker Test

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03123926
Enrollment
600
Registered
2017-04-21
Start date
2016-11-30
Completion date
2018-12-31
Last updated
2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Delivery

Keywords

spontaneous preterm birth, lipids, biomarkers

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.

Interventions

None listed

Sponsors

BABYNOSTICS
CollaboratorUNKNOWN
Sprim Advanced Life Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Biomarkers (serum)6-12 monthssubjects 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.
Cervical length6-12 monthsCervical length \<15, 20, 25 mm
Lipid analysis (serum and DBS)6-12 monthsLipid profiles of preterm birth compared to term birth.

Countries

Philippines

Contacts

Primary ContactJillian De Leon
jillian.deleon@sprim.com
Backup ContactOrawan Suitthimeathegorn
orawan.suitthimeathegorn@sprim.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026