Placenta AccretaNCT04573452
Galectin-3 and Placenta Accreta
An observational study of Placenta Accreta, run by Assiut University at 1 site in Egypt.
Trial summary
Galectins are a family of carbohydrate-binding proteins that have a high affinity to galactosides, its protein portion is located in the nucleus and the cytoplasm with its carbohydrate recognition domain which has high ability to be glycosylated inside or outside the cell. 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?
- Galectin-3 and Placental Galactin-3
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Oct 2021
- 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
- No healthy volunteers
- Adult
Study population: Pregnant women
Who may be able to join
- Pregnant women between 28-32 weeks.
- Age between 20-40 years.
- Singleton pregnancy.
- Women with suspicion of placenta accreta
- Cases with mild vaginal bleeding or not having any vaginal bleeding.
Who cannot join
- Women are known to have any medical disorders.
- Patients with known bleeding disorders or on anticoagulant therapy.
- Patients refuse to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Galectin-3 in the Pathogenesis and Prediction of Placenta Accreta
Galectins are a family of carbohydrate-binding proteins that have a high affinity to galactosides, its protein portion is located in the nucleus and the cytoplasm with its carbohydrate recognition domain which has high ability to be glycosylated inside or outside the cell.
They are expressed by vascular endothelium, immune cells (macrophages, neutrophils, and mast cells), uterus, placenta, cardiac muscle, liver, epithelium of the gastrointestinal tract, and many other tissues.
Read more
Although some galectins have intracellular functions, the majority of them have extracellular activities, which facilitate their contribution to cell adhesion, cell activation, and inflammation. Galectin-3 (Gal-3) is a unique pentamer of the galectins family and it is involved in both physiological functions; cell growth and differentiation, and pathological conditions; inflammation, fibrosis, and metastasis.
Regarding pregnancy, Gal-3 is proved to participate in angiogenesis, embryo developmental processes, and modulation of maternal immunity.
- Conditions
- Placenta Accreta
- Being tested
- Galectin-3, Placental Galactin-3
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galectin-3Diagnostic test
Measurement of Gal-3 in Serum which will be isolated from the blood samples by ELISA (Enzyme-Linked immunosorbent Assay) (R\&D Systems, Minneapolis, MN, USA).
Placental Galactin-3Diagnostic test
Measurement of Gal-3 in Villous and decidual tissues homogenate by ELISA
| Study group | Role | What they receive |
|---|---|---|
| Normal pregnancy group | Not described Receives: Diagnostic Test: Galectin-3; Diagnostic Test: Placental Galactin-3 | |
| Placenta accreta at 24-32 weeks group | Not described Receives: Diagnostic Test: Galectin-3; Diagnostic Test: Placental Galactin-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Galactin 3 level in the blood
measured by ng/ml
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 62 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
- NCT04573452
- Sponsor's protocol ID
- G-PA
- Status last verified
- Oct 2022
- First submitted
- 28 Sep 2020
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Galectin-3 in the Pathogenesis and Prediction of Placenta Accreta
- ClinicalTrials.gov ID
- NCT04573452
- Acronym / sponsor ID
- G-PA
- Conditions
- Placenta Accreta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 5 Oct 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.
Galectins are a family of carbohydrate-binding proteins that have a high affinity to galactosides, its protein portion is located in the nucleus and the cytoplasm with its carbohydrate recognition domain which has high ability to be glycosylated inside or outside the cell.
They are expressed by vascular endothelium, immune cells (macrophages, neutrophils, and mast cells), uterus, placenta, cardiac muscle, liver, epithelium of the gastrointestinal tract, and many other tissues.
Although some galectins have intracellular functions, the majority of them have extracellular activities, which facilitate their contribution to cell adhesion, cell activation, and inflammation. Galectin-3 (Gal-3) is a unique pentamer of the galectins family and it is involved in both physiological functions; cell growth and differentiation, and pathological conditions; inflammation, fibrosis, and metastasis.
Regarding pregnancy, Gal-3 is proved to participate in angiogenesis, embryo developmental processes, and modulation of maternal immunity.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal pregnancy group | – | Diagnostic Test: Galectin-3, Diagnostic Test: Placental Galactin-3 |
| Placenta accreta at 24-32 weeks group | – | Diagnostic Test: Galectin-3, Diagnostic Test: Placental Galactin-3 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (5 listed)
- Pregnant women between 28-32 weeks.
- Age between 20-40 years.
- Singleton pregnancy.
- Women with suspicion of placenta accreta
- Cases with mild vaginal bleeding or not having any vaginal bleeding.
Key exclusion criteria (3 listed)
- Women are known to have any medical disorders.
- Patients with known bleeding disorders or on anticoagulant therapy.
- Patients refuse to participate.
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 |
|---|---|---|
| Galectin-3Measurement of Gal-3 in Serum which will be isolated from the blood samples by ELISA (Enzyme-Linked immunosorbent Assay) (R\&D Systems, Minneapolis, MN, USA). | Diagnostic test | Normal pregnancy group, Placenta accreta at 24-32 weeks group |
| Placental Galactin-3Measurement of Gal-3 in Villous and decidual tissues homogenate by ELISA | Diagnostic test | Normal pregnancy group, Placenta accreta at 24-32 weeks group |
Primary outcome
Galactin 3 level in the blood
Time frame: 6 weeks
measured by ng/ml
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 10 Oct 2022.
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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?
An observational study 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 5 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 10 Oct 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?
Galactin 3 level in the blood (time frame: 6 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 10 Oct 2022.