NCT04683562

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

December 21, 2020

Last Update Submit

August 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Placental Netrin-1 level

    will be measured by using enzyme-linked immunosorbent assay (ELİSA) in placental homogenate

    4 weeks

Study Arms (2)

Normal pregnancy group

OTHER
Other: Pregnant women at 28-32 weeksOther: at delivery

Placenta accreta group

OTHER
Other: Pregnant women at 28-32 weeksOther: at delivery

Interventions

Pregnant women at gestational age 28-32 weeks

Normal pregnancy groupPlacenta accreta group

women delivered at term

Normal pregnancy groupPlacenta accreta group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20-40 years.
  • Singleton pregnancy.
  • Women with suspicion of PA by two-dimensional (2D) gray scale imaging and color Doppler flow mapping

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woman's Health Hospital

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
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 24, 2020

Study Start

December 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

August 22, 2022

Record last verified: 2022-08

Locations