NCT03798964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

January 23, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2020

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

1.8 years

First QC Date

January 2, 2019

Last Update Submit

June 22, 2022

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • Heparanase expression

    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.

    Six months

Study Arms (3)

Elective term cesarean

Low-risk women undergoing elective term cesarean section

Other: Placental analysis

Term vaginal delivery

Low-risk women undergoing term vaginal delivery

Other: Placental analysis

Preterm vaginal delivery

Women undergoing preterm vaginal delivery

Other: Placental analysis

Interventions

Placental analysisOTHER

Analysis of placenta to determine expression of heparanase

Elective term cesareanPreterm vaginal deliveryTerm vaginal delivery

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women attending our obstetrical unit

You may qualify if:

  • Singleton pregnancy

You may not qualify if:

  • High-risk patients
  • Multiple pregnancy
  • Significant maternal illness
  • Significant fetal anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Rinat Gabbay-Benziv, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 10, 2019

Study Start

January 23, 2019

Primary Completion

November 24, 2020

Study Completion

November 24, 2020

Last Updated

June 28, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)