NCT04573452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

September 28, 2020

Last Update Submit

October 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Galactin 3 level in the blood

    measured by ng/ml

    6 weeks

Study Arms (2)

Normal pregnancy group

Diagnostic Test: Galectin-3Diagnostic Test: Placental Galactin-3

Placenta accreta at 24-32 weeks group

Diagnostic Test: Galectin-3Diagnostic Test: Placental Galactin-3

Interventions

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).

Normal pregnancy groupPlacenta accreta at 24-32 weeks group
Placental Galactin-3DIAGNOSTIC_TEST

Measurement of Gal-3 in Villous and decidual tissues homogenate by ELISA

Normal pregnancy groupPlacenta accreta at 24-32 weeks group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women

You may qualify if:

  • 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.

You may not qualify if:

  • Women are known to have any medical disorders.
  • Patients with known bleeding disorders or on anticoagulant therapy.
  • Patients refuse to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 5, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

October 10, 2022

Record last verified: 2022-10

Locations