Placenta AccretaNCT04683562
Netrin-1 and Placenta Accreta
A study testing Pregnant women at 28-32 weeks and at delivery in people with Placenta Accreta, run by Assiut University at 1 site in Egypt.
Trial summary
Netrin-1 is a secreted protein, which was first identified as a neuronal guidance factor. It is expressed in a multitude of tissues as pancreas, lung, breast, and placenta. Netrin-1 is a multifunctional protein, involved in cell polarity, adhesion, angiogenesis, apoptosis, migration, morphogenesis, and differentiation… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Pregnant women at 28-32 weeks and at delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Jun 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20-40 years.
- Singleton pregnancy.
- Women with suspicion of PA by two-dimensional (2D) gray scale imaging and color Doppler flow mapping
Who cannot join
- Multiple pregnancy,
- Fetal anomalies,
- Preterm premature rupture of membranes, or infection
- Any medical disorders, such as thyroid dysfunction, hypertension, and gestational diabetes
- Patients with known bleeding disorders or on anticoagulant therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Implication of Placental Netrin-1 Receptor DCC in the Pathophysiology of Placenta Accreta
Netrin-1 is a secreted protein, which was first identified as a neuronal guidance factor. It is expressed in a multitude of tissues as pancreas, lung, breast, and placenta. Netrin-1 is a multifunctional protein, involved in cell polarity, adhesion, angiogenesis, apoptosis, migration, morphogenesis, and differentiation of various cell types. Most of netrin-1 activity occur through signaling pathways induced by its two main receptors, DCC (deleted in colorectal cancer) and UNC5H (uncoordinated-5 homolog). Its receptors have been linked to the processes of apoptosis and angiogenesis. In absence of netrin-1, DCC and UNC5H receptors lead to apoptosis. In contrary, in presence of netrin-1, receptors transduce molecular cascades leading to proliferation, differentiation and migration of the cells. Netrin-1 has been involved in the pathogenesis of multiple diseases, as diabetes, cardiovascular diseases, and cancer. Serum Netrin-1 levels were high in preeclamptic patients.
- Conditions
- Placenta Accreta
- Being tested
- Pregnant women at 28-32 weeks, at delivery
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant women at 28-32 weeksOther
Pregnant women at gestational age 28-32 weeks
at deliveryOther
women delivered at term
| Study group | Role | What they receive |
|---|---|---|
| Normal pregnancy group | Other | Not described Receives: Other: Pregnant women at 28-32 weeks; Other: at delivery |
| Placenta accreta group | Other | Not described Receives: Other: Pregnant women at 28-32 weeks; Other: at delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental Netrin-1 level
will be measured by using enzyme-linked immunosorbent assay (ELİSA) in placental homogenate
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Dec 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683562
- Sponsor's protocol ID
- PA-NT1
- Status last verified
- Aug 2022
- First submitted
- 21 Dec 2020
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- 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 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implication of Placental Netrin-1 Receptor DCC in the Pathophysiology of Placenta Accreta
- ClinicalTrials.gov ID
- NCT04683562
- Acronym / sponsor ID
- PA-NT1
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 24 Dec 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.
Netrin-1 is a secreted protein, which was first identified as a neuronal guidance factor. It is expressed in a multitude of tissues as pancreas, lung, breast, and placenta. Netrin-1 is a multifunctional protein, involved in cell polarity, adhesion, angiogenesis, apoptosis, migration, morphogenesis, and differentiation of various cell types. Most of netrin-1 activity occur through signaling pathways induced by its two main receptors, DCC (deleted in colorectal cancer) and UNC5H (uncoordinated-5 homolog). Its receptors have been linked to the processes of apoptosis and angiogenesis. In absence of netrin-1, DCC and UNC5H receptors lead to apoptosis. In contrary, in presence of netrin-1, receptors transduce molecular cascades leading to proliferation, differentiation and migration of the cells. Netrin-1 has been involved in the pathogenesis of multiple diseases, as diabetes, cardiovascular diseases, and cancer. Serum Netrin-1 levels were high in preeclamptic patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal pregnancy group | Other | Other: Pregnant women at 28-32 weeks, Other: at delivery |
| Placenta accreta group | Other | Other: Pregnant women at 28-32 weeks, Other: at delivery |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20-40 years.
- Singleton pregnancy.
- Women with suspicion of PA by two-dimensional (2D) gray scale imaging and color Doppler flow mapping
Key exclusion criteria (5 listed)
- Multiple pregnancy,
- Fetal anomalies,
- Preterm premature rupture of membranes, or infection
- Any medical disorders, such as thyroid dysfunction, hypertension, and gestational diabetes
- Patients with known bleeding disorders or on anticoagulant therapy.
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 |
|---|---|---|
| Pregnant women at 28-32 weeksPregnant women at gestational age 28-32 weeks | Other | Normal pregnancy group, Placenta accreta group |
| at deliverywomen delivered at term | Other | Normal pregnancy group, Placenta accreta group |
Primary outcome
Placental Netrin-1 level
Time frame: 4 weeks
will be measured by using enzyme-linked immunosorbent assay (ELİSA) in placental homogenate
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 22 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
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?
A study testing Pregnant women at 28-32 weeks and at delivery in people with 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 3 inclusion and 5 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 22 Aug 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 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?
Placental Netrin-1 level (time frame: 4 weeks). 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 22 Aug 2022.