Galectin-3 and Placenta Accreta

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04573452
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Placenta Accreta	Diagnostic Test: Galectin-3; Diagnostic Test: Placental Galactin-3

Study Design

• Study Type: Observational
• Actual Enrollment: 62 participants
• Observational Model: Case-Crossover
• Time Perspective: Cross-Sectional
• Official Title: The Role of Galectin-3 in the Pathogenesis and Prediction of Placenta Accreta
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Oct 1, 2021
• Actual Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Normal pregnancy group	Diagnostic Test: Galectin-3; 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).; Diagnostic Test: Placental Galactin-3; Measurement of Gal-3 in Villous and decidual tissues homogenate by ELISA
Placenta accreta at 24-32 weeks group	Diagnostic Test: Galectin-3; 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).; Diagnostic Test: Placental Galactin-3; Measurement of Gal-3 in Villous and decidual tissues homogenate by ELISA

Outcome Measures

Primary Outcome Measures

1. Galactin 3 level in the blood [6 weeks]

   measured by ng/ml

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Pregnant women between 28-32 weeks.

2. Age between 20-40 years.

3. Singleton pregnancy.

4. Women with suspicion of placenta accreta

5. Cases with mild vaginal bleeding or not having any vaginal bleeding.

Exclusion Criteria:

1. Women are known to have any medical disorders.

2. Patients with known bleeding disorders or on anticoagulant therapy.

3. Patients refuse to participate.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women Health Hospital - Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammed Khairy Ali, Assistant professor, Assiut University
• ClinicalTrials.gov Identifier: NCT04573452
• Other Study ID Numbers: G-PA
• First Posted: Oct 5, 2020
• Last Update Posted: Feb 8, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Placenta Accreta

Study Results

No Results Posted as of Feb 8, 2022