Early Onset Preeclampsia and Nectin-4

Serum Nectin-4 Levels in Patients With Early Onset Preeclampsia

Early-onset Preeclampsia (PE) is a pregnancy disorder which may present with adverse pregnancy outcomes. Nectin-4 is an adhesion molecule mainly expressed in placenta. This study aimed to evaluate the relationship between early onset Preeclampsia and serum Nectin 4 levels.

Study Overview

• Status: Completed
• Conditions: Pre-Eclampsia; Oxidative Stress; Early Onset Preeclampsia; Immunologic Diseases in Pregnancy
• Intervention / Treatment: Diagnostic test: serum marker levels

Detailed Description

Preeclampsia is assumed as a two-stage disorder arising from defective trophoblast invasion and failure of spiral artery remodeling as the main step responsible for the pathogenesis. PE is classified according to the disease onset time as early-onset PE before 34 weeks and late-onset PE after 34 weeks. Late-onset PE is more commonly seen and accepted as a mild maternal reaction to pregnancy. In early-onset PE, unlike the late-onset, due to the improper placental invasion, the diffuse placental ischemia and the resulting oxidative stress begin at early gestation. Thus, the early-onset PE may result in severe disease leading to perinatal and maternal morbidity and mortality.

The nectins are calcium-independent immunoglobulin-like celladhesion molecules and have a pivotal role at cellular junctions, as well as physiological regulations(8). Placenta expressesfor types of nectins; nectin-1, nectin-2, nectin-3, and nectin-4. They are localized at tight junctions and gap junctions of syncitiotrophoblasts(9). Nectin-4 is a relatively novel member of nectin family which has been detected only in placenta and airway epithelium in healthy subjects.

Despite, there has been no study published yet to reveal the soluble nectin-4 levels in preeclampsia as well as in early onset disease. In this study, we aimed to investigate the serum nectin-4 levels in early-onset preeclampsia in comparison of the healthy pregnancies.

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34010
    • Hatice Akkaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Comparison to the level of soluble nectin-4 in early-onset PE, compared to healthy pregnancies

Description

Inclusion Criteria:

• spontaneous,
• singleton pregnancies
• above the 24 weeks of gestations
• positive fetal cardiac activity

Exclusion Criteria:

• multiple gestations,
• chronic hypertension
• hypothyroidism
• known malignancy,- diabetes mellitus,
• presence of fetal or maternal infection,
• clinical signs of chorioamnionitis (maternal fever, vaginal discharge, fetal tachycardia),
• hepatic or renal failure
• Placenta previa or pregnancies accompanied congenital fetal abnormalities or aneuploidies

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 (Early onset Preeclampsia ); 43 cases The groups were matched for gestational age and gravidity.	Diagnostic test: serum marker levels; two groups comparisons
Group 2 ( Healthy pregnant woman) control group; 41 cases The groups were matched for gestational age and gravidity	Diagnostic test: serum marker levels; two groups comparisons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum nectin-4 levels	ng/ml	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI (body mass index)	kg/m2	5 minute
Tansion Arterial	mm Hg	5 minute

Collaborators and Investigators

• Sponsor: Hatice Akkaya

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: October 16, 2021
• First Submitted That Met QC Criteria: October 16, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 16, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: early onset preeclampsia; nectin-4; advers pregnancy outcome; hypertansion
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia; Immune System Diseases
• Other Study ID Numbers: KAEK/2020.05.13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: If needed
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: journals editors request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No