ClinicalTrials.gg
Status unknownNCT05207800Updated Jan 26, 2022

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 in Preterm Premature Rupture of Membrane, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Status unknown. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-26.

Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years to 40 Years
Sex
Female
01

Study 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).

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).

02

Conditions studied

  • Preterm Premature Rupture of Membrane

Keywords

  • pentraxin 3
  • heparin-binding protein
  • chorioamnionitis
  • preterm premature rupture of membranes
  • term premature rupture of membranes
03

In context

Preterm Premature Rupture of the Membranes

75 studies on the registry are indexed under Preterm Premature Rupture of the Membranes; 17 are open to participants now.

This study's planned enrollment of 180 is above the median of 100 across 24 observational studies indexed under Preterm Premature Rupture of the Membranes.

Browse Preterm Premature Rupture of the Membranes studies →

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 137 studies on the registry; 46 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 to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

pregnant women

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

  1. The pregnant woman is born at a gestational age of 24-40 weeks;
  2. The pregnant woman has a single child;
  3. Regular obstetric examination during pregnancy with complete obstetric examination data was diagnosed as premature rupture of membranes (PROM).

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy complicated with medical and surgical diseases, such as thyroid dysfunction and chronic hypertension;
  2. Insufficiency of vital organ function or complicated tumor;
  3. Pregnant women with other pregnancy complications besides PROM, such as preeclampsia, etc.;
  4. Neonates had major congenital malformations (congenital anal atresia, congenital biliary atresia, congenital heart disease and so on, whether prenatal suspicion or diagnosis postpartum)
  5. Neonatal septicemia, hemolytic disease or other diseases affecting metabolism.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • healthy pregnant woman

    healthy pregnant woman

    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

    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

    Other: The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.

Interventions

  • OtherThe 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.

06

What researchers measure

Primary outcomes

  1. PTX3 and HBP concentrations in maternal blood

    PTX3 and HBP concentrations in maternal blood

    Time frame: 24 weeks to 40 weeks gestation

Secondary outcomes

  1. PTX3 and HBP concentrations in placental tissue

    PTX3 and HBP concentrations in placental tissue

    Time frame: 24 weeks to 40 weeks gestation

Other outcomes

  1. PTX3 and HBP concentrations in amniotic fluid

    PTX3 and HBP concentrations in amniotic fluid

    Time frame: 24 weeks to 40 weeks gestation

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2022; primary completion for Dec 2022, 10 months later.

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

Registered
Jan 10, 2022
First posted
Jan 26, 2022
StartEst.
Feb 10, 2022
Primary completionEst.
Dec 31, 2022
CompletionEst.
Jul 31, 2023
Last update
Jan 26, 2022
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 Jan 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05207800
Responsible party
Sponsor
First posted
Jan 26, 2022
Start date
Feb 10, 2022 (estimated)
Primary completion
Dec 31, 2022 (estimated)
Completion
Jul 31, 2023 (estimated)
Last update
Jan 26, 2022

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 Jan 2022. You cannot join it, but the record below documents what was studied.

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