Preterm DeliveryNCT03123926
Spontaneous Preterm Birth Marker Test
An observational study of Preterm Delivery, run by Sprim Advanced Life Sciences at 1 site in Philippines.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Delivery
- How many people
- 600 participants
- Where
- 1 sitePhilippines
- Study dates
- Nov 2016to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Estimated 600 symptomatic women aged ≥ 18 years with pregnancy at 24 to 28 weeks of gestation.
Who may be able to join
- Pregnancy women aged ≥ 18 years with pregnancy at 24 to 28 weeks of gestation.
Who cannot join
- Subjects with any conditions or diseases that investigator considers it is not appropriate to enter the study.
Trial locations and contacts
1 site in 1 country.
Jillian De Leon contact
Orawan Suitthimeathegorn contact
Philippines1 site, 1 recruiting
- Recruiting
The Perinatal Association of the Philippines
Quezon, Brgy Malaya
Jenny Rose Rodaje
About this study
Official title: Spontaneous Preterm Birth Marker Test (SPBMT): Preterm Prediction Prospective Study
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
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical length
Cervical length <15, 20, 25 mm
Measured: 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.
Measured: 6-12 months
Lipid analysis (serum and DBS)
Lipid profiles of preterm birth compared to term birth.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startNov 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sprim Advanced Life Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- BABYNOSTICS
- Responsible party
- Sponsor
- Investigators
- Mariano Diosdado V., MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123926
- Sponsor's protocol ID
- BAB-0316
- Status last verified
- Apr 2017
- First submitted
- 20 Feb 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Preterm Birth Marker Test (SPBMT): Preterm Prediction Prospective Study
- ClinicalTrials.gov ID
- NCT03123926
- Acronym / sponsor ID
- BAB-0316
- Conditions
- Preterm Delivery
- Keywords
- spontaneous preterm birth, lipids, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sprim Advanced Life SciencesUniversity, hospital or other
- Collaborators
- BABYNOSTICS
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Estimated 600 symptomatic women aged ≥ 18 years with pregnancy at 24 to 28 weeks of gestation.
Key inclusion criteria (1 listed)
- Pregnancy women aged ≥ 18 years with pregnancy at 24 to 28 weeks of gestation.
Key exclusion criteria (1 listed)
- Subjects with any conditions or diseases that investigator considers it is not appropriate to enter the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cervical length
Time frame: 6-12 months
Cervical length <15, 20, 25 mm
Biomarkers (serum)
Time frame: 6-12 months
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.
Lipid analysis (serum and DBS)
Time frame: 6-12 months
Lipid profiles of preterm birth compared to term birth.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jillian De Leon contact
Orawan Suitthimeathegorn contact
Mariano Diosdado V., MD principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Delivery, run by Sprim Advanced Life Sciences at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jillian De Leon (jillian.deleon@sprim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical length (time frame: 6-12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.