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

Preterm Premature Rupture of Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05207800
• Other study ID #: SAHoWMU-CR2021-07-207
• Status: Not yet recruiting
• Start date: February 10, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: January 2022
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: July 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chorioamnionitis
• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membrane
• Rupture

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PTX3 and HBP concentrations in amniotic fluid	PTX3 and HBP concentrations in amniotic fluid	24 weeks to 40 weeks gestation
Primary	PTX3 and HBP concentrations in maternal blood	PTX3 and HBP concentrations in maternal blood	24 weeks to 40 weeks gestation
Secondary	PTX3 and HBP concentrations in placental tissue	PTX3 and HBP concentrations in placental tissue	24 weeks to 40 weeks gestation