Preterm BirthNCT03798964
The Expression Heparanase in Term and Preterm Placentas
An observational study of Preterm Birth, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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) . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Placental analysis
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Jan 2019to 24 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women attending our obstetrical unit
Who may be able to join
- Singleton pregnancy
Who cannot join
- High-risk patients
- Multiple pregnancy
- Significant maternal illness
- Significant fetal anomaly
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Preterm Birth
- Being tested
- Placental analysis
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placental analysisOther
Analysis of placenta to determine expression of heparanase
| Study group | Role | What they receive |
|---|---|---|
| Elective term cesarean | Low-risk women undergoing elective term cesarean section Receives: Other: Placental analysis | |
| Term vaginal delivery | Low-risk women undergoing term vaginal delivery Receives: Other: Placental analysis | |
| Preterm vaginal delivery | Women undergoing preterm vaginal delivery Receives: Other: Placental analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start23 Jan 2019
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rinat Gabbay-Benziv, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798964
- Sponsor's protocol ID
- HYMC-0119-18
- Status last verified
- Jun 2022
- First submitted
- 2 Jan 2019
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expression Heparanase in Term and Preterm Placentas
- ClinicalTrials.gov ID
- NCT03798964
- Acronym / sponsor ID
- HYMC-0119-18
- Conditions
- Preterm Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elective term cesarean | – | Other: Placental analysisLow-risk women undergoing elective term cesarean section |
| Term vaginal delivery | – | Other: Placental analysisLow-risk women undergoing term vaginal delivery |
| Preterm vaginal delivery | – | Other: Placental analysisWomen undergoing preterm vaginal delivery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women attending our obstetrical unit
Key inclusion criteria (1 listed)
- Singleton pregnancy
Key exclusion criteria (4 listed)
- High-risk patients
- Multiple pregnancy
- Significant maternal illness
- Significant fetal anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placental analysisAnalysis of placenta to determine expression of heparanase | Other | Elective term cesarean, Preterm vaginal delivery, Term vaginal delivery |
Primary outcome
Heparanase expression
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rinat Gabbay-Benziv, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heparanase expression (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.