Early Onset Preeclampsia and Nectin-4

NCT ID: NCT05098691

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2020-12-30

Brief Summary

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.

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.

Conditions

Pre-Eclampsia; Early Onset Preeclampsia; Oxidative Stress; Immunologic Diseases in Pregnancy

Keywords

early onset preeclampsia; nectin-4; advers pregnancy outcome; hypertansion

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1 (Early onset Preeclampsia )

43 cases The groups were matched for gestational age and gravidity.

serum marker levels

Intervention Type: DIAGNOSTIC_TEST

two groups comparisons

Group 2 ( Healthy pregnant woman) control group

41 cases The groups were matched for gestational age and gravidity

serum marker levels

Intervention Type: DIAGNOSTIC_TEST

two groups comparisons

Interventions

serum marker levels

two groups comparisons

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hatice Akkaya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hatice Akkaya

associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hatice Akkaya

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KAEK/2020.05.13

Identifier Type: -

Identifier Source: org_study_id