## Protocol Section
### Identification Module
**NCT ID:** NCT06437535

**Brief Title:** Role of Vaspin in Pathophysiology of Pre-eclampsia

**Official Title:** The Pathophysiological Role of Vaspin and Apoptosis in Pre-eclamptic Obese Women

#### Organization Study ID Info
**ID:** vaspin and pre-eclampsia
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Aya Ali Ibrahim Sayed

**Investigator Title:** principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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).

**Detailed Description:** • Pre-eclampsia(PE) is defined as new onset hypertension after 20 weeks gestation with evidence of maternal organ or uteroplacental dysfunction or proteinuria. The majority of maternal deaths related to PE can be avoided by providing timely and effective care and delivery to high-risk women. Thus, optimization of health care for women during pregnancy to prevent and treat PE . PE classified clinically to mild and severe sub types as Pregnant women with BP≥160/110 mmHg and proteinuria ≥3+ reading on dipstick are classified as having severe PE while pregnant women with systolic blood pressure of 140 -159 mmHg, diastolic blood pressure of 90-109 mmHg, and proteinuria ≥1+ reading on dipstick are classified as having mild PE.. Vaspin, a member of adipokines was first isolated from the visceral adipose tissue of the rat abdominal obesity model (OLETF). It belongs to the serine protease inhibitors and acts through a protein G-coupled receptor - GRP78. Vaspin has also found in the liver, pancreas, cerebrospinal ﬂuid, hypothalamus, intestine, and lungs.it has pleiotropic functions that include regulating inﬂammatory response, insulin resistance and the development of obesity. Vaspin like other adipokines including leptin and adiponectin can aﬀect the female reproduction system like ovary. Vaspin expression was detected in another reproductive component, the placenta. In humans, vaspin was localized in cytotrophoblasts and syncytiotrophoblasts in ﬁrst-trimester placentas, but only in syncytiotrophoblasts in third-trimester placentas. Apoptosis plays a critical role in the homeostasis regulation of normal placental development. However, excessive placental apoptosis leads to placental dysfunction, which may consequence in pregnancy disorders such as preeclampsia. vaspin acts as an antiapoptotic agent in ovary by attenuating the tumor necrosis factor (TNF-α)-induced apoptosis by promoting autophagy also has been shown to inhibit macrophage apoptosisAnti apoptotic eﬀects of vaspin have also been described in human osteoblast cells by upregulation of the expression of BCL2 and downregulation of BAX through the Mitogen-activated kinase (MAP3/1)pathway and Protein kinase B(AKT) pathway.

### Conditions Module

**Conditions:**

- Pre-Eclampsia

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 75

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** will include 25 women with normal weight and normal blood pressure .

**Label:** Group 1

#### Arm Group 2

**Description:** :will include 25 obsese women with normal blood pressure.

**Label:** Group2

#### Arm Group 3

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

**Label:** Group 3

### Outcomes Module

#### Primary Outcomes

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

**Measure:** vaspin level in serum and placenta

**Time Frame:** one year

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

**Measure:** level of bcl2 expression in placenta

**Time Frame:** one year

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

**Measure:** vaspin and bcl2

**Time Frame:** one year

#### Secondary Outcomes

**Description:** Correlation between vaspin level and bcl2 level with patient demographic data(Age -parity).

**Measure:** vapin level and bcl2 level and patient demographic data

**Time Frame:** one year

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

* 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

Exclusion Criteria:

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

**Gender Based:** True

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** Pregnant women who will come for termination of pregnancy

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ayaa.alii2468@gmail.com

**Name:** Aya ali ibrahim sayed, master

**Phone:** +20 010096908832

**Role:** CONTACT

**Contact 2:**

**Email:** mrafadeil@gmail.com

**Name:** Mahmoud Raafat Abdel-fadeil, professor

**Phone:** +20 01001644429

**Role:** CONTACT

### References Module

#### References

**Citation:** 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:** 31375930

**Citation:** 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:** 37123551

**Citation:** 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:** 34359881

**Citation:** 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:** 31752432

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000046110

- Term: Hypertension, Pregnancy-Induced

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M7633

- Name: Eclampsia

- Relevance: HIGH

- As Found: Eclampsia

- ID: M14106

- Name: Pre-Eclampsia

- Relevance: HIGH

- As Found: Pre-Eclampsia

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M25635

- Name: Hypertension, Pregnancy-Induced

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T2019

- Name: Eclampsia

- Relevance: HIGH

- As Found: Eclampsia

### Condition Browse Module - Meshes

- ID: D000004461

- Term: Eclampsia

- ID: D000011225

- Term: Pre-Eclampsia

### Misc Info Module

- Version Holder: 2024-05-31
