Netrin-1 and Placenta Accreta
Primary Purpose
Placenta Accreta
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pregnant women at 28-32 weeks
at delivery
Sponsored by
About this trial
This is an interventional diagnostic trial for Placenta Accreta
Eligibility Criteria
Inclusion Criteria:
- Age between 20-40 years.
- Singleton pregnancy.
- Women with suspicion of PA by two-dimensional (2D) gray scale imaging and color Doppler flow mapping
Exclusion Criteria:
- 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.
Sites / Locations
- Woman's Health Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Normal pregnancy group
Placenta accreta group
Arm Description
Outcomes
Primary Outcome Measures
Placental Netrin-1 level
will be measured by using enzyme-linked immunosorbent assay (ELİSA) in placental homogenate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04683562
Brief Title
Netrin-1 and Placenta Accreta
Official Title
The Implication of Placental Netrin-1 Receptor DCC in the Pathophysiology of Placenta Accreta
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal pregnancy group
Arm Type
Other
Arm Title
Placenta accreta group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Pregnant women at 28-32 weeks
Intervention Description
Pregnant women at gestational age 28-32 weeks
Intervention Type
Other
Intervention Name(s)
at delivery
Intervention Description
women delivered at term
Primary Outcome Measure Information:
Title
Placental Netrin-1 level
Description
will be measured by using enzyme-linked immunosorbent assay (ELİSA) in placental homogenate
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 20-40 years.
Singleton pregnancy.
Women with suspicion of PA by two-dimensional (2D) gray scale imaging and color Doppler flow mapping
Exclusion Criteria:
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.
Facility Information:
Facility Name
Woman's Health Hospital
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Netrin-1 and Placenta Accreta
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