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Spontaneous Preterm Birth Marker Test

NCT ID: NCT03123926

Last Updated: 2017-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Preterm Delivery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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BABYNOSTICS

UNKNOWN

Sponsor Role collaborator

Sprim Advanced Life Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariano Diosdado V., MD

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

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The Perinatal Association of the Philippines

Quezon, Brgy Malaya, Philippines

Site Status RECRUITING

Countries

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Philippines

Central Contacts

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Jillian De Leon

Role: CONTACT

[email protected]

Orawan Suitthimeathegorn

Role: CONTACT

[email protected]

Facility Contacts

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Jenny Rose Rodaje

Role: primary

Other Identifiers

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BAB-0316

Identifier Type: -

Identifier Source: org_study_id

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