Preterm BirthPBMBCVFNCT03974724
Preterm Birth Prediction by Measurement of Biomarkers in Cervical Vaginal Fluid
An observational study of Preterm Birth, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the predictive value of 7 biomarkers cervical vaginal fluid on future preterm birth in pregnant women whose gestational age are 16 to 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 1 Aug 2022
- 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: The investigators aim to recruit pregnant women visit their hospital whose gestational age are between 16 to 24 weeks and meet the criteria for inclusion during the study periods. The investigators introduce the study to those pregnant women who visit their hospital early after confirming pregancy till beyond the inclusion gestational age.
Who may be able to join
- Age≥18years
- Between 16-24 weeks gestation
- Signed informed consent
- Note:The investigators also recruit pregnant women who have the following risk factors for preterm birth and meet the criteria for admission: uterine malformation, history of induction, history of premature birth, premature rupture of membranes, history of abortion, history of cervical conization and cervical cerclage, vaginal bleeding, cervical shortening, Multiple pregnancies - twins, triplets, polyhydramnios, smoking, drug use, placenta previa, pregnancy through assisted reproductive technology.
Who cannot join
- Rupture of the membrane before sampling
- Manual or ultrasound vaginal examination within 6 hours of sampling
- Vaginal bleeding within 48 hours of sampling (significant vaginal bleeding)
- Note: exclusion criteria for sample are listed as follow:
- After the delivery results are verified, the samples are excluded according to the sample exclusion criteria and the samples that do not meet the criteria are excluded, including:
- Therapeutic preterm birth
Show all 9Show fewer
- Samples of blood contamination
- Progesterone treatment at the time of sampling
- Situations that other researchers believe need to be excluded
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 010
Sijian Li, resident, +8618811749581, li_sijian@126.com
About this study
The purpose of this study is to determine the predictive value of 7 biomarkers cervical vaginal fluid on future preterm birth in pregnant women whose gestational age are 16 to 24 weeks.
Read the detailed description
Preterm births (PTBs) refers to a delivery with a gestational age prior to 37 weeks, which can be divided into extreme PTBs (<28 weeks), early PTBs (28-32 weeks), and advanced PTBs (32-37 weeks). The prevalence of PTBs is on a global scale, with more than 1 million PTB per year in China (with a prevalence of 7%), ranking the second in the world. PTBs is the main cause of perinatal death. Meanwhile, premature infants are at higher risk of short-term or long-term complications such as respiratory distress syndrome and mental retardation, causing huge economic and mental burdens on families and society. Most PTBs are spontaneous or caused by premature rupture of membranes (PROM) while the precisely reason remains unknown. Effective early prediction of PTBs and timely intervention are key to reducing PTBs and improving adverse pregnancy outcomes. Current prediction methods for PTBs can be divided into the following three categories: risk factor assessment, cervical length measurement, and biomarkers. However, about half of premature pregnant women do not have high-risk factors, and only premature risk factors cannot accurately identify prematurely at-risk populations. Biomarkers such as fetal fibronectin (fFN) have a very high negative predictive value (more than 95%), but positive predictive value is low (with 200 ng/ml as a cut-off value, and fFN predicts a positive predictive value for preterm birth at <34 weeks gestation reaching only 37.7%). Other biomarkers such as hyperphosphorylated insulin-like growth factor binding protein-1 (phIGFBP1) and placenta α1 microglobulin (PAMG-1) were detected, but their predictive effects were still dissatisfactory.
Therefore, there is no currently effective screening method for predicting the occurrence of PTBs. How to accurately predict and diagnose PTBs is still an unsolved problem in obstetrics. Our previous study identified seven biomarkers in cervical vaginal fluid(CVF) that may be associated with preterm birth and preliminary validation in animal experiments, suggesting that biomarkers in selected CVF may be effective predictors of PTBs, but larger samples of clinical trials are required for validation.
- Conditions
- Preterm Birth
- Keywords
- Preterm birth, Prediction, Cervical vaginal fluid
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm birth
Preterm birth refers to delivery with the gestational age prior to 37 weeks
Measured: At the time of delivery
Secondary outcomes (3)
Neonatal low birth weight(LBW)
LBW is defined as birth weigh less than 2500g
Measured: At the time of delivery
respiratory distress syndrome(RDS)
the number of neonatal RDS occurs in participants' newborns
Measured: At the time of delivery
neonatal ICU(NICU) admission
the number of neonates admitted to NICU
Measured: At the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 May 2019
- Primary completion1 May 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ESCO Beijing Technologies Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974724
- Sponsor's protocol ID
- Preterm birth prediction
- Acronym
- PBMBCVF
- Status last verified
- Jun 2019
- First submitted
- 16 May 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Birth Prediction by Measurement of Biomarkers in Cervical Vaginal Fluid
- ClinicalTrials.gov ID
- NCT03974724
- Acronym / sponsor ID
- PBMBCVF / Preterm birth prediction
- Conditions
- Preterm Birth
- Keywords
- Preterm birth, Prediction, Cervical vaginal fluid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- ESCO Beijing Technologies Co., Ltd.
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 5 Jun 2019 (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 purpose of this study is to determine the predictive value of 7 biomarkers cervical vaginal fluid on future preterm birth in pregnant women whose gestational age are 16 to 24 weeks.
Detailed description
Preterm births (PTBs) refers to a delivery with a gestational age prior to 37 weeks, which can be divided into extreme PTBs (<28 weeks), early PTBs (28-32 weeks), and advanced PTBs (32-37 weeks). The prevalence of PTBs is on a global scale, with more than 1 million PTB per year in China (with a prevalence of 7%), ranking the second in the world. PTBs is the main cause of perinatal death. Meanwhile, premature infants are at higher risk of short-term or long-term complications such as respiratory distress syndrome and mental retardation, causing huge economic and mental burdens on families and society. Most PTBs are spontaneous or caused by premature rupture of membranes (PROM) while the precisely reason remains unknown. Effective early prediction of PTBs and timely intervention are key to reducing PTBs and improving adverse pregnancy outcomes. Current prediction methods for PTBs can be divided into the following three categories: risk factor assessment, cervical length measurement, and biomarkers. However, about half of premature pregnant women do not have high-risk factors, and only premature risk factors cannot accurately identify prematurely at-risk populations. Biomarkers such as fetal fibronectin (fFN) have a very high negative predictive value (more than 95%), but positive predictive value is low (with 200 ng/ml as a cut-off value, and fFN predicts a positive predictive value for preterm birth at <34 weeks gestation reaching only 37.7%). Other biomarkers such as hyperphosphorylated insulin-like growth factor binding protein-1 (phIGFBP1) and placenta α1 microglobulin (PAMG-1) were detected, but their predictive effects were still dissatisfactory.
Therefore, there is no currently effective screening method for predicting the occurrence of PTBs. How to accurately predict and diagnose PTBs is still an unsolved problem in obstetrics. Our previous study identified seven biomarkers in cervical vaginal fluid(CVF) that may be associated with preterm birth and preliminary validation in animal experiments, suggesting that biomarkers in selected CVF may be effective predictors of PTBs, but larger samples of clinical trials are required for validation.
Study design
- Observational model
- Cohort
- 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
- The investigators aim to recruit pregnant women visit their hospital whose gestational age are between 16 to 24 weeks and meet the criteria for inclusion during the study periods. The investigators introduce the study to those pregnant women who visit their hospital early after confirming pregancy till beyond the inclusion gestational age.
Key inclusion criteria (4 listed)
- Age≥18years
- Between 16-24 weeks gestation
- Signed informed consent
- Note:The investigators also recruit pregnant women who have the following risk factors for preterm birth and meet the criteria for admission: uterine malformation, history of induction, history of premature birth, premature rupture of membranes, history of abortion, history of cervical conization and cervical cerclage, vaginal bleeding, cervical shortening, Multiple pregnancies - twins, triplets, polyhydramnios, smoking, drug use, placenta previa, pregnancy through assisted reproductive technology.
Key exclusion criteria (9 listed)
- Rupture of the membrane before sampling
- Manual or ultrasound vaginal examination within 6 hours of sampling
- Vaginal bleeding within 48 hours of sampling (significant vaginal bleeding)
- After the delivery results are verified, the samples are excluded according to the sample exclusion criteria and the samples that do not meet the criteria are excluded, including:
- Therapeutic preterm birth
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
Preterm birth
Time frame: At the time of delivery
Preterm birth refers to delivery with the gestational age prior to 37 weeks
3 secondary outcomes
Neonatal low birth weight(LBW)
Time frame: At the time of delivery
respiratory distress syndrome(RDS)
Time frame: At the time of delivery
neonatal ICU(NICU) admission
Time frame: At the time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
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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.
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 Birth, run by Peking Union Medical College Hospital at 1 site in China.
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 4 inclusion and 9 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 5 Jun 2019. 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 China. 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 Jinsong Gao, Professor (+8618601106857, gaojsong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm birth (time frame: At the time of delivery). 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 5 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.