ClinicalTrials.gg
Status unknownNCT03123926Updated Apr 21, 2017

Spontaneous Preterm Birth Marker Test

An observational study in Preterm Delivery, sponsored by Sprim Advanced Life Sciences. Status unknown at 1 site in Philippines. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-21.

Sponsored by Sprim Advanced Life Sciences · Observational

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Preterm Delivery

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Keywords

  • spontaneous preterm birth
  • lipids
  • biomarkers
03

In context

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's planned enrollment of 600 is above the median of 120 across 806 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Sprim Advanced Life Sciences is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Cervical length

    Cervical length \<15, 20, 25 mm

    Time frame: 6-12 months

  2. 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.

    Time frame: 6-12 months

  3. Lipid analysis (serum and DBS)

    Lipid profiles of preterm birth compared to term birth.

    Time frame: 6-12 months

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Study locations

1 of 1 sites recruiting
  • The Perinatal Association of the Philippines
    Quezon, Brgy Malaya, Philippines
    Recruiting
    • Jenny Rose Rodaje · Contact
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2016, a primary completion of Dec 2017 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2017
First posted
Apr 21, 2017
Start
Nov 2016
Primary completionEst.
Dec 2017
CompletionEst.
Dec 2018
Last update
Apr 21, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03123926
Lead sponsor
Sprim Advanced Life Sciences
Collaborators
BABYNOSTICS
Responsible party
Sponsor
First posted
Apr 21, 2017
Start date
Nov 2016
Primary completion
Dec 2017 (estimated)
Completion
Dec 2018 (estimated)
Last update
Apr 21, 2017

Study contacts

Jillian De Leon
Contact
jillian.deleon@sprim.com
Orawan Suitthimeathegorn
Contact
orawan.suitthimeathegorn@sprim.com
Mariano Diosdado V., MD
principal investigator · MD

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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