Preterm BirthNCT06664554
Predictive Value of Maternal Blood Protein Signatures in Preterm Birth
An observational study of Preterm Birth, run by HBI Solutions Inc. at 5 sites in China.
Trial summary
Accurate prediction of preterm birth is critical for clinical management to improve the neonatal and maternal outcomes. A clinical challenge remains for current predicting biomarkers due to the complexity and multifactorial nature of underlying causes of preterm birth. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- How many people
- 18,000 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jan 2021to 30 Jun 2024
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: General women with pregnancy
Who may be able to join
- Pregnant women between18 and 45 years of age
- Single pregnancy
- Consent to participate in the study
Who cannot join
- Premature rupture of membranes
- Uterine malformation
- Fetal malformation
- Pregestational Diabetes
- Systemic diseases (chronic kidney disease, autoimmune disease, etc.)
- Serious medical illness (renal insufficiency, congestive heart disease, chronic respiratory insufficiency, etc.).
Show all 13Show fewer
- Suffering from other disease unfavorable to the trial such as metal illness
- Any maternal or fetal condition that requires termination of pregnancy.
- Active vaginal bleeding.
- Multifetal pregnancy with greater than or equal to 2 fetuses.
- Lack of clinical outcome or incomplete basic information
- Iatrogenic premature delivery or induced labor
- Lack of consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan
Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University,
Jinan, Shandong
Department of Obstetrics and Gynecology, the Eighth Affiliated Hospital, Sun Yat-sen University;
Shenzhen, Guangdong
Department of Obstetrics, Shenzhen Maternity and Child Healthcare Hospital
Shenzhen, Guangdong
Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Accurate prediction of preterm birth is critical for clinical management to improve the neonatal and maternal outcomes. A clinical challenge remains for current predicting biomarkers due to the complexity and multifactorial nature of underlying causes of preterm birth.
This study aims to evaluate the prediction performance of new maternal blood biomarkers (proteomic markers) on the occurrence of preterm birth.
Read the detailed description
Preterm birth (PTB), defined by delivery before 37 weeks of gestational age, represents a substantial public health challenge due to its elevated rates of neonatal morbidity and mortality worldwide. The prevalence of PTB exhibits variation, ranging from approximately 12-13% in the USA to 5-9% in other developed nations, underscoring a complex issue marked by regional disparities.
Emphasizing its significant public health ramifications, PTB is recognized as a primary contributor to mortality among children under five, particularly with 40% of deaths occurring within the first month of life in this demographic. Following PTB, infants face an increased vulnerability to severe complications like respiratory distress syndrome, intraventricular hemorrhage, and necrotizing enterocolitis, accentuating the acute threats to infant well-being and longevity. Addressing these early-life hurdles requires the formulation of robust strategies for prediction and prevention to alleviate the immediate hazards linked with premature birth.
Preventing PTB crucially depends on accurately identifying women at high risk. Interventions like vaginal progesterone and cervical cerclage are recommended for those with a short cervical length. However, the effectiveness of these strategies is frequently compromised by limitations in current screening methods, which struggle to accurately predict PTB. This underscores a significant gap in effectively identifying all at-risk women, underscoring the necessity for enhanced screening techniques to more precisely pinpoint women who would benefit from preventive interventions.
Current screening methods, primarily based on measuring cervical length and assessing historical risk factors, are inadequate in capturing the multifaceted nature of PTB risk, leading to missed opportunities for intervention and prevention. This inadequacy underscores the importance of developing methods that can more accurately identify women at high risk. Research efforts aimed at addressing these challenges suggest the potential of integrating new biomarkers and maternal characteristics into screening protocols to improve the predictive accuracy of PTB screenings.
Building upon the premise that the placenta plays a pivotal role in fetal health regulation, and that insights into the pathologic mechanisms leading to spontaneous preterm birth can be gleaned from the placental transcriptome, the investigators utilized existing transcriptomic data from the public domain, employing bioinformatics methodologies. This data was further complemented by quantitative proteomics analysis techniques using mass spectrometry. Through this integrated approach, the investigators have developed a novel PTB screening panel comprising three protein biomarkers. The efficacy and prediction performance of this three-protein predictor will be evaluated in this study with independent cohorts.
- Conditions
- Preterm Birth
- Keywords
- Preterm birth, Maternal blood, Serological protein
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm birth | Pregnancy with delivery before 37 weeks of gestational age | |
| Term birth control | Pregnancy with delivery at 37 weeks or later of gestational age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of preterm birth
The primary outcome is the prediction of preterm birth, defined as pregnancy duration of less than 37 weeks. Preterm birth prediction score is calculated as sum of the z-score of 3 proteins' multiple of median (MoM) values.
Measured: After blood draw during doctor's visit before 37 weeks of gestation
Secondary outcomes (1)
Sensitivity, Specificity, Positive predictive value (PPV), Negative predictive value (NPV)
Sensitivity, Specificity, PPV and NPV was calculate for identification the preterm birth cases using pre-defined threshold of prediction score.
Measured: After blood draw during doctor's visit before 37 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Jan 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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
- 18,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- HBI Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Maternity & Child Healthcare Hospital
- Responsible party
- Principal investigator, Qiong Luo, Women's Hospital School Of Medicine Zhejiang University
- Investigators
- Qiong Luo, M.D. Ph.D., Principal investigator, Department of Obstetrics, Women's Hospital of Zhejiang University, School of Medicine, Hangzhou, 310006, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664554
- Sponsor's protocol ID
- PTB_01
- Status last verified
- Dec 2024
- First submitted
- 28 Oct 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romero R, Dey SK, Fisher SJ. Preterm labor: one syndrome, many causes. Science. 2014 Aug 15;345(6198):760-5. doi: 10.1126/science.1251816. Epub 2014 Aug 14.
PubMed 25124429Boyle AK, Rinaldi SF, Norman JE, Stock SJ. Preterm birth: Inflammation, fetal injury and treatment strategies. J Reprod Immunol. 2017 Feb;119:62-66. doi: 10.1016/j.jri.2016.11.008. Epub 2016 Dec 2.
PubMed 28122664
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Maternal Blood Protein Signatures in Preterm Birth
- ClinicalTrials.gov ID
- NCT06664554
- Acronym / sponsor ID
- PTB_01
- Conditions
- Preterm Birth
- Keywords
- Preterm birth, Maternal blood, Serological protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,000 participants (actual)
- Lead sponsor
- HBI Solutions Inc.Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Maternity & Child Healthcare Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 29 Oct 2024 (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.
Accurate prediction of preterm birth is critical for clinical management to improve the neonatal and maternal outcomes. A clinical challenge remains for current predicting biomarkers due to the complexity and multifactorial nature of underlying causes of preterm birth.
This study aims to evaluate the prediction performance of new maternal blood biomarkers (proteomic markers) on the occurrence of preterm birth.
Detailed description
Preterm birth (PTB), defined by delivery before 37 weeks of gestational age, represents a substantial public health challenge due to its elevated rates of neonatal morbidity and mortality worldwide. The prevalence of PTB exhibits variation, ranging from approximately 12-13% in the USA to 5-9% in other developed nations, underscoring a complex issue marked by regional disparities.
Emphasizing its significant public health ramifications, PTB is recognized as a primary contributor to mortality among children under five, particularly with 40% of deaths occurring within the first month of life in this demographic. Following PTB, infants face an increased vulnerability to severe complications like respiratory distress syndrome, intraventricular hemorrhage, and necrotizing enterocolitis, accentuating the acute threats to infant well-being and longevity. Addressing these early-life hurdles requires the formulation of robust strategies for prediction and prevention to alleviate the immediate hazards linked with premature birth.
Preventing PTB crucially depends on accurately identifying women at high risk. Interventions like vaginal progesterone and cervical cerclage are recommended for those with a short cervical length. However, the effectiveness of these strategies is frequently compromised by limitations in current screening methods, which struggle to accurately predict PTB. This underscores a significant gap in effectively identifying all at-risk women, underscoring the necessity for enhanced screening techniques to more precisely pinpoint women who would benefit from preventive interventions.
Current screening methods, primarily based on measuring cervical length and assessing historical risk factors, are inadequate in capturing the multifaceted nature of PTB risk, leading to missed opportunities for intervention and prevention. This inadequacy underscores the importance of developing methods that can more accurately identify women at high risk. Research efforts aimed at addressing these challenges suggest the potential of integrating new biomarkers and maternal characteristics into screening protocols to improve the predictive accuracy of PTB screenings.
Building upon the premise that the placenta plays a pivotal role in fetal health regulation, and that insights into the pathologic mechanisms leading to spontaneous preterm birth can be gleaned from the placental transcriptome, the investigators utilized existing transcriptomic data from the public domain, employing bioinformatics methodologies. This data was further complemented by quantitative proteomics analysis techniques using mass spectrometry. Through this integrated approach, the investigators have developed a novel PTB screening panel comprising three protein biomarkers. The efficacy and prediction performance of this three-protein predictor will be evaluated in this study with independent cohorts.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm birth | – | –Pregnancy with delivery before 37 weeks of gestational age |
| Term birth control | – | –Pregnancy with delivery at 37 weeks or later of gestational age |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- General women with pregnancy
Key inclusion criteria (3 listed)
- Pregnant women between18 and 45 years of age
- Single pregnancy
- Consent to participate in the study
Key exclusion criteria (13 listed)
- Premature rupture of membranes
- Uterine malformation
- Fetal malformation
- Pregestational Diabetes
- Systemic diseases (chronic kidney disease, autoimmune disease, etc.)
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
Prediction of preterm birth
Time frame: After blood draw during doctor's visit before 37 weeks of gestation
The primary outcome is the prediction of preterm birth, defined as pregnancy duration of less than 37 weeks. Preterm birth prediction score is calculated as sum of the z-score of 3 proteins' multiple of median (MoM) values.
1 secondary outcome
Sensitivity, Specificity, Positive predictive value (PPV), Negative predictive value (NPV)
Time frame: After blood draw during doctor's visit before 37 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Background: PubMed 25124429Romero R, Dey SK, Fisher SJ. Preterm labor: one syndrome, many causes. Science. 2014 Aug 15;345(6198):760-5. doi: 10.1126/science.1251816. Epub 2014 Aug 14.
- Background: PubMed 28122664Boyle AK, Rinaldi SF, Norman JE, Stock SJ. Preterm birth: Inflammation, fetal injury and treatment strategies. J Reprod Immunol. 2017 Feb;119:62-66. doi: 10.1016/j.jri.2016.11.008. Epub 2016 Dec 2.
- Individual participant dataSharing planned: No
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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.
Qiong Luo, M.D. Ph.D. principal investigator
Department of Obstetrics, Women's Hospital of Zhejiang University, School of Medicine, Hangzhou, 310006, China
5 sites 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 HBI Solutions Inc. at 5 sites 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of preterm birth (time frame: After blood draw during doctor's visit before 37 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06664554, which also lists 2 linked publications.
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 Dec 2024.