Pathophysiology of Placenta AccretaNCT04628169
Impact of Netrin-1 in the Pathophysiology of Placenta Accreta Spectrum
An observational study of Pathophysiology of Placenta Accreta, run by Assiut University at 1 site in Egypt.
Trial summary
The main goal of this study is to assess the role of Netrin 1, neogenin and ZEB1 in PAS-associated invasion Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pathophysiology of Placenta Accreta
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Jul 2023
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 30 PAS specimens and 30 placental specimens from matched control.
Who may be able to join
- PAS patients who underwent hysterectomy to allow proper pathologic grading of PAS
Who cannot join
- patients with fundal and middle anterior or posterior placenta,
- pregnancy associated with morbid conditions such as hypertension, diabetes mellitus, autoimmune disease, cardiac disease, renal disease, history of anemia, blood transfusion, other blood diseases and endocrinal disease; fetal distress or intrauterine growth retardation.
- uterine scar pregnancies were excluded
Trial locations and contacts
1 site in 1 country.
About this study
The main goal of this study is to assess the role of Netrin 1, neogenin and ZEB1 in PAS-associated invasion
Read the detailed description
- To evaluate the immunohistochemical expression of these proteins in PAS specimens in comparison with the control placental tissues.
- To correlate their expression with the demographic parameters.
- To assess the correlation between their expression in PAS specimens.
- Conditions
- Pathophysiology of Placenta Accreta
- Being tested
- no intervention applied
- Keywords
- Netrin-1, neogenin,PAS, zeb-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention appliedOther
no intervention applied
| Study group | Role | What they receive |
|---|---|---|
| group A | 30 placental specimens of PAS Receives: Other: no intervention applied | |
| group B | 30 placental specimens of heaithy women with normal pregnancy Receives: Other: no intervention applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of netrin-1 in the pathophysiology of placenta accreta spectrum
- Evaluation of the immunohistochemical expression of netrin 1 in PAS specimens in comparison with the control placental tissues.
- Evaluation of the immunohistochemical expression of neogenin in PAS specimens in comparison with the control placental tissues
- Evaluation of the immunohistochemical expression of ZEB1 in PAS specimens in comparison with the control placental tissues.
- Correlate their immunohistochemical expression with the demographic parameters and assess the correlation between their expression in PAS specimens.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathophysiology of Placenta AccretaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Mohammed Mohammed Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628169
- Sponsor's protocol ID
- netrin-1 in placenta accreta
- Status last verified
- Sep 2024
- First submitted
- 9 Nov 2020
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Netrin-1 in the Pathophysiology of Placenta Accreta Spectrum
- ClinicalTrials.gov ID
- NCT04628169
- Acronym / sponsor ID
- netrin-1 in placenta accreta
- Conditions
- Pathophysiology of Placenta Accreta
- Keywords
- Netrin-1, neogenin,PAS, zeb-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 13 Nov 2020 (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.
The main goal of this study is to assess the role of Netrin 1, neogenin and ZEB1 in PAS-associated invasion
Detailed description
- To evaluate the immunohistochemical expression of these proteins in PAS specimens in comparison with the control placental tissues.
- To correlate their expression with the demographic parameters.
- To assess the correlation between their expression in PAS specimens.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Other: no intervention applied30 placental specimens of PAS |
| group B | – | Other: no intervention applied30 placental specimens of heaithy women with normal pregnancy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 30 PAS specimens and 30 placental specimens from matched control.
Key inclusion criteria (1 listed)
- PAS patients who underwent hysterectomy to allow proper pathologic grading of PAS
Key exclusion criteria (3 listed)
- patients with fundal and middle anterior or posterior placenta,
- pregnancy associated with morbid conditions such as hypertension, diabetes mellitus, autoimmune disease, cardiac disease, renal disease, history of anemia, blood transfusion, other blood diseases and endocrinal disease; fetal distress or intrauterine growth retardation.
- uterine scar pregnancies were excluded
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 |
|---|---|---|
| no intervention appliedno intervention applied | Other | group A, group B |
Primary outcome
impact of netrin-1 in the pathophysiology of placenta accreta spectrum
Time frame: baseline
1. Evaluation of the immunohistochemical expression of netrin 1 in PAS specimens in comparison with the control placental tissues. 2. Evaluation of the immunohistochemical expression of neogenin in PAS specimens in comparison with the control placental tissues 3. Evaluation of the immunohistochemical expression of ZEB1 in PAS specimens in comparison with the control placental tissues. 4. Correlate their immunohistochemical expression with the demographic parameters and assess the correlation between their expression in PAS specimens.
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 20 Sep 2024.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pathophysiology of Placenta Accreta, run by Assiut University at 1 site in Egypt.
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 3 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 20 Sep 2024. 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 Egypt. 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?
impact of netrin-1 in the pathophysiology of placenta accreta spectrum (time frame: baseline). 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 20 Sep 2024.