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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03123926
Other study ID # BAB-0316
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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