The Expression Heparanase in Term and Preterm Placentas

NCT ID: NCT03798964

Last Updated: 2022-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-23

Study Completion Date

2020-11-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Elective term cesarean

Low-risk women undergoing elective term cesarean section

Placental analysis

Intervention Type OTHER

Analysis of placenta to determine expression of heparanase

Term vaginal delivery

Low-risk women undergoing term vaginal delivery

Placental analysis

Intervention Type OTHER

Analysis of placenta to determine expression of heparanase

Preterm vaginal delivery

Women undergoing preterm vaginal delivery

Placental analysis

Intervention Type OTHER

Analysis of placenta to determine expression of heparanase

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placental analysis

Analysis of placenta to determine expression of heparanase

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Singleton pregnancy

Exclusion Criteria

* High-risk patients
* Multiple pregnancy
* Significant maternal illness
* Significant fetal anomaly
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rinat Gabbay-Benziv, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hille Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HYMC-0119-18

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.