The Expression Heparanase in Term and Preterm Placentas

• Sponsor: Hillel Yaffe Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03798964
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 22
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Heparanase is an endo-β-glucuronidase that cleaves heparin-sulfate (HS) side chains of heparan sulfate proteoglycans, an integral constituent of the extra cellular matrix (ECM).

This study aims to investigate the association between heparanase expression in the human placenta and preterm birth (PTB) .

The investigators hypothesize that an abnormal placentation causes relative placental ischemia that induces higher rates of heparanase expression.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth	Other: Placental analysis

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Expression Heparanase in Term and Preterm Placentas
• Actual Study Start Date: Jan 23, 2019
• Actual Primary Completion Date: Nov 24, 2020
• Actual Study Completion Date: Nov 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Elective term cesarean Low-risk women undergoing elective term cesarean section	Other: Placental analysis; Analysis of placenta to determine expression of heparanase
Term vaginal delivery Low-risk women undergoing term vaginal delivery	Other: Placental analysis; Analysis of placenta to determine expression of heparanase
Preterm vaginal delivery Women undergoing preterm vaginal delivery	Other: Placental analysis; Analysis of placenta to determine expression of heparanase

Outcome Measures

Primary Outcome Measures

1. Heparanase expression [Six months]

   Heparanase expression in the human placenta following delivery will be evaluated by western blot analysis in the three groups and will be compared to determine differences in the levels.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Singleton pregnancy

Exclusion Criteria:

• High-risk patients

• Multiple pregnancy

• Significant maternal illness

• Significant fetal anomaly

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hille Yaffe Medical Center	Hadera		Israel	38100

Sponsors and Collaborators

• Hillel Yaffe Medical Center

Investigators

• Principal Investigator: Rinat Gabbay-Benziv, MD, Hillel Yaffe Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hillel Yaffe Medical Center
• ClinicalTrials.gov Identifier: NCT03798964
• Other Study ID Numbers: HYMC-0119-18
• First Posted: Jan 10, 2019
• Last Update Posted: Jun 28, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Premature Birth

Study Results

No Results Posted as of Jun 28, 2022