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

• Conditions: Preterm Premature Rupture of Membrane
• Interventions: Other: The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.

• Registration Number: NCT05207800
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-24
• Last Update Submitted: 2022-01-24
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-01-26
• Study Start: 2022-02-10
• Primary Completion: 2022-12-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pregnant women with TPROM	The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.	pregnant women with term premature rupture of membranes
healthy pregnant woman	The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.	healthy pregnant woman
pregnant women with PPROM	The concentrations of PTX3 and HBP were monitored in maternal blood, placental tissue and amniotic fluid.	pregnant women with preterm premature rupture of membranes

Primary Outcome Measures

Name	Time	Method
PTX3 and HBP concentrations in maternal blood	24 weeks to 40 weeks gestation	PTX3 and HBP concentrations in maternal blood

Secondary Outcome Measures

Name	Time	Method
PTX3 and HBP concentrations in placental tissue	24 weeks to 40 weeks gestation	PTX3 and HBP concentrations in placental tissue