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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Placenta Accreta

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
December 21, 2020
Last Updated
August 19, 2022
Sponsor
Assiut University
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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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