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CompletedNCT03798964Updated Jun 28, 2022

The Expression Heparanase in Term and Preterm Placentas

An observational study in Preterm Birth, sponsored by Hillel Yaffe Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-06-28.

Sponsored by Hillel Yaffe Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

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Conditions studied

  • Preterm Birth

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In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 20 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant women attending our obstetrical unit

Inclusion criteria

  • Singleton pregnancy

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherPlacental analysis

    Analysis of placenta to determine expression of heparanase

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What researchers measure

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.

    Time frame: Six months

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Study locations

1 site
  • Hille Yaffe Medical Center
    Hadera, 38100, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03798964
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
Jan 10, 2019
Start date
Jan 23, 2019
Primary completion
Nov 24, 2020
Completion
Nov 24, 2020
Last update
Jun 28, 2022

Study contacts

Rinat Gabbay-Benziv, MD
principal investigator · Hillel Yaffe Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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