NCT06437535

Brief Summary

  • To investigate the possible role of vaspin and apoptosis in pre-eclamptic obese women .
  • To compare the serum as well as placental level of vaspin in normotensive and severe pre-eclamptic obese women.
  • To compare the serum as well as placental level of vaspin in normotensive normal body weight and severe pre-eclamptic obese women women .
  • To compare placental apoptosis marker Bcl2 in normotensive and severe pre-eclamptic obese women .
  • To compare placental apoptosis marker Bcl2 in normotensive normal body weight and severe pre-eclamptic obese women .
  • Correlation between vaspin and apoptosis in pre-eclamptic obese women .
  • Correlation between vaspin level and apoptosis marker with patient demographic data(Age -parity).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Status
not yet recruiting

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

May 20, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 20, 2024

Last Update Submit

May 29, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • vaspin level in serum and placenta

    \- measure level of vaspin in serum as well as its level in placenta in patients with pre-eclampsia and women with normal pregnancy

    one year

  • level of bcl2 expression in placenta

    measure level of gene expression of apoptotic marker bcl2 by PCR in placenta in patients with preeclampsia and women with normal pregnancy

    one year

  • vaspin and bcl2

    correlation between level of vaspin and bcl2 gene expression in patients of preeclamsia and women with normal pregnancy

    one year

Secondary Outcomes (1)

  • vapin level and bcl2 level and patient demographic data

    one year

Study Arms (3)

Group 1

will include 25 women with normal weight and normal blood pressure .

Group2

:will include 25 obsese women with normal blood pressure.

Group 3

: will include 25 obese women with confirmed diagnosis of severe preeclampsia .

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women who will come for termination of pregnancy

You may qualify if:

  • Pregnant women who will come to hospital for termination of pregnancy .
  • Confirmed diagnosis of preeclampsia for study groups.
  • Control group will include Normotensive pregnant women.
  • Age group 18-35 years.
  • gestional age at termination of pregnancy : group 1\&2 : from 38 to 40 weeks group 3:terminatin of pregnancy regardless of gestional age

You may not qualify if:

  • Pregnant women who do not consent to participate.
  • Diabeteic patients .
  • History of pre-gestional hypertension.
  • History of chronic renal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Bergman L, Torres-Vergara P, Penny J, Wikstrom J, Nelander M, Leon J, Tolcher M, Roberts JM, Wikstrom AK, Escudero C. Investigating Maternal Brain Alterations in Preeclampsia: the Need for a Multidisciplinary Effort. Curr Hypertens Rep. 2019 Aug 2;21(9):72. doi: 10.1007/s11906-019-0977-0.

    PMID: 31375930BACKGROUND
  • Fondjo LA, Sarpong D, Owiredu WKBA, Opoku S, Adu-Bonsaffoh K, Teviu E. Effect of magnesium sulfate treatment on mediators of endothelial dysfunction and electrolytes in mild and severe preeclampsia: A case-control study. Health Sci Rep. 2023 Apr 26;6(5):e1232. doi: 10.1002/hsr2.1232. eCollection 2023 May.

    PMID: 37123551BACKGROUND
  • Kurowska P, Mlyczynska E, Dawid M, Jurek M, Klimczyk D, Dupont J, Rak A. Review: Vaspin (SERPINA12) Expression and Function in Endocrine Cells. Cells. 2021 Jul 6;10(7):1710. doi: 10.3390/cells10071710.

    PMID: 34359881BACKGROUND
  • Kurowska P, Mlyczynska E, Dawid M, Opydo-Chanek M, Dupont J, Rak A. In Vitro Effects of Vaspin on Porcine Granulosa Cell Proliferation, Cell Cycle Progression, and Apoptosis by Activation of GRP78 Receptor and Several Kinase Signaling Pathways Including MAP3/1, AKT, and STAT3. Int J Mol Sci. 2019 Nov 19;20(22):5816. doi: 10.3390/ijms20225816.

    PMID: 31752432BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Aya ali ibrahim sayed, master

CONTACT

Mahmoud Raafat Abdel-fadeil, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 31, 2024

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

May 31, 2024

Record last verified: 2024-05