Predictive Value of Maternal Serum Pentraxin 3 (PTX 3) and Heparin-binding Protein (HBP) for Chorioamnionitis in Preterm Premature Rupture of Membranes

January 24, 2022 updated by: Second Affiliated Hospital of Wenzhou Medical University

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant women

Description

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:

  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 bilirubin metabolism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy pregnant woman
Other: 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.
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.
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.
The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTX3 and HBP concentrations in maternal blood
Time Frame: 24 weeks to 40 weeks gestation
PTX3 and HBP concentrations in maternal blood
24 weeks to 40 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTX3 and HBP concentrations in placental tissue
Time Frame: 24 weeks to 40 weeks gestation
PTX3 and HBP concentrations in placental tissue
24 weeks to 40 weeks gestation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTX3 and HBP concentrations in amniotic fluid
Time Frame: 24 weeks to 40 weeks gestation
PTX3 and HBP concentrations in amniotic fluid
24 weeks to 40 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 10, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2021-07-207

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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