Preterm Premature Rupture of MembraneNCT05207800
Predictive Value of Maternal Serum Pentraxin 3 (PTX 3) and Heparin-binding Protein (HBP) for Chorioamnionitis in Preterm Premature Rupture of Membranes
An observational study of Preterm Premature Rupture of Membrane, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
Objective: The aim of this study was to investigate the predictive value of maternal serum pentraxin 3 (PTX3) and heparin-binding protein (HBP) for chorioamnionitis in preterm premature rupture of membranes (PPROM). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Premature Rupture of Membrane
- What is being tested?
- The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2022to 31 Jul 2023
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women
Who may be able to join
- The pregnant woman is born at a gestational age of 24-40 weeks;
- The pregnant woman has a single child;
- Regular obstetric examination during pregnancy with complete obstetric examination data was diagnosed as premature rupture of membranes (PROM).
Who cannot join
- Pregnancy complicated with medical and surgical diseases, such as thyroid dysfunction and chronic hypertension;
- Insufficiency of vital organ function or complicated tumor;
- Pregnant women with other pregnancy complications besides PROM, such as preeclampsia, etc.;
- Neonates had major congenital malformations (congenital anal atresia, congenital biliary atresia, congenital heart disease and so on, whether prenatal suspicion or diagnosis postpartum)
- Neonatal septicemia, hemolytic disease or other diseases affecting bilirubin metabolism.
About this study
Objective: The aim of this study was to investigate the predictive value of maternal serum pentraxin 3 (PTX3) and heparin-binding protein (HBP) for chorioamnionitis in preterm premature rupture of membranes (PPROM).
Method: This observational prospective cohort study included a total of 180 pregnant women at 24-40 gestational weeks. There were 60 cases of term premature rupture of membranes (TPROM), 60 cases of preterm premature rupture of membranes（PPROM）and 60 cases of healthy women. The concentrations of PTX3 and HBP were measured in maternal blood and amniotic fluid using an enzyme-linked immunosorbent assay (ELISA). Western immunoblotting was used to analyze the expression of PTX3 and HBP in placental tissue. The localization and immunoreaction of PTX3 and HBP in placenta were determined via immunohistochemistry (IHC).
- Conditions
- Preterm Premature Rupture of Membrane
- Being tested
- The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.
- Keywords
- pentraxin 3, heparin-binding protein, chorioamnionitis, preterm premature rupture of membranes, term premature rupture of membranes
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Chorioamnionitis, Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.Other
The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.
| Study group | Role | What they receive |
|---|---|---|
| healthy pregnant woman | healthy pregnant woman Receives: Other: The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid. | |
| pregnant women with TPROM | pregnant women with term premature rupture of membranes Receives: Other: The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid. | |
| pregnant women with PPROM | pregnant women with preterm premature rupture of membranes Receives: Other: The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTX3 and HBP concentrations in maternal blood
PTX3 and HBP concentrations in maternal blood
Measured: 24 weeks to 40 weeks gestation
Secondary outcomes (1)
PTX3 and HBP concentrations in placental tissue
PTX3 and HBP concentrations in placental tissue
Measured: 24 weeks to 40 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start10 Feb 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of MembraneStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe 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
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207800
- Sponsor's protocol ID
- SAHoWMU-CR2021-07-207
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 26 Jan 2022
- 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 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Maternal Serum Pentraxin 3 (PTX 3) and Heparin-binding Protein (HBP) for Chorioamnionitis in Preterm Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT05207800
- Acronym / sponsor ID
- SAHoWMU-CR2021-07-207
- Conditions
- Preterm Premature Rupture of Membrane
- Keywords
- pentraxin 3, heparin-binding protein, chorioamnionitis, preterm premature rupture of membranes, term premature rupture of membranes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 26 Jan 2022 (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.
Objective: The aim of this study was to investigate the predictive value of maternal serum pentraxin 3 (PTX3) and heparin-binding protein (HBP) for chorioamnionitis in preterm premature rupture of membranes (PPROM).
Method: This observational prospective cohort study included a total of 180 pregnant women at 24-40 gestational weeks. There were 60 cases of term premature rupture of membranes (TPROM), 60 cases of preterm premature rupture of membranes（PPROM）and 60 cases of healthy women. The concentrations of PTX3 and HBP were measured in maternal blood and amniotic fluid using an enzyme-linked immunosorbent assay (ELISA). Western immunoblotting was used to analyze the expression of PTX3 and HBP in placental tissue. The localization and immunoreaction of PTX3 and HBP in placenta were determined via immunohistochemistry (IHC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy pregnant woman | – | Other: The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.healthy pregnant woman |
| pregnant women with TPROM | – | Other: The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.pregnant women with term premature rupture of membranes |
| pregnant women with PPROM | – | Other: The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.pregnant women with preterm premature rupture of membranes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women
Key inclusion criteria (3 listed)
- The pregnant woman is born at a gestational age of 24-40 weeks;
- The pregnant woman has a single child;
- Regular obstetric examination during pregnancy with complete obstetric examination data was diagnosed as premature rupture of membranes (PROM).
Key exclusion criteria (5 listed)
- Pregnancy complicated with medical and surgical diseases, such as thyroid dysfunction and chronic hypertension;
- Insufficiency of vital organ function or complicated tumor;
- Pregnant women with other pregnancy complications besides PROM, such as preeclampsia, etc.;
- Neonates had major congenital malformations (congenital anal atresia, congenital biliary atresia, congenital heart disease and so on, whether prenatal suspicion or diagnosis postpartum)
- Neonatal septicemia, hemolytic disease or other diseases affecting bilirubin metabolism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid. | Other | healthy pregnant woman, pregnant women with PPROM, pregnant women with TPROM |
Primary outcome
PTX3 and HBP concentrations in maternal blood
Time frame: 24 weeks to 40 weeks gestation
PTX3 and HBP concentrations in maternal blood
1 secondary outcome
PTX3 and HBP concentrations in placental tissue
Time frame: 24 weeks to 40 weeks gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Premature Rupture of Membrane, run by Second Affiliated Hospital of Wenzhou Medical University.
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 5 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
PTX3 and HBP concentrations in maternal blood (time frame: 24 weeks to 40 weeks gestation). 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 26 Jan 2022.