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

NCT05207800 | Unknown

• 1 other identifier: SAHoWMU-CR2021-07-207
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Preterm Premature Rupture of Membrane

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PTX3 and HBP concentrations in maternal blood

  PTX3 and HBP concentrations in maternal blood

  24 weeks to 40 weeks gestation

Secondary Outcomes (1)

• PTX3 and HBP concentrations in placental tissue

  24 weeks to 40 weeks gestation

Other Outcomes (1)

• PTX3 and HBP concentrations in amniotic fluid

  24 weeks to 40 weeks gestation

Study Arms (3)

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

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.

healthy pregnant woman; pregnant women with PPROM; pregnant women with TPROM

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes; Chorioamnionitis; Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 26, 2022
• Study Start: February 10, 2022
• Primary Completion: December 31, 2022
• Study Completion: July 31, 2023
• Last Updated: January 26, 2022

Record last verified: 2022-01