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CompletedNCT05098691Updated Oct 28, 2021

Early Onset Preeclampsia and Nectin-4

An observational study in Pre-Eclampsia, Early Onset Preeclampsia and Oxidative Stress, sponsored by Hatice Akkaya. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by Hatice Akkaya · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
84
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • early onset preeclampsia
  • nectin-4
  • advers pregnancy outcome
  • hypertansion
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
84 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1 (Early onset Preeclampsia )

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

    Diagnostic Test: serum marker levels

  • Group 2 ( Healthy pregnant woman) control group

    41 cases The groups were matched for gestational age and gravidity

    Diagnostic Test: serum marker levels

Interventions

  • Diagnostic testserum marker levels

    two groups comparisons

05

What researchers measure

Primary outcomes

  1. serum nectin-4 levels

    ng/ml

    Time frame: 1 hour

Secondary outcomes

  1. BMI (body mass index)

    kg/m2

    Time frame: 5 minute

  2. Tansion Arterial

    mm Hg

    Time frame: 5 minute

06

Study locations

1 site
  • Hatice Akkaya
    İstanbul, 34010, Turkey
07

References and documents

Individual participant data

Plan to share: Yes — If needed

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05098691
Lead sponsor
Hatice Akkaya
Responsible party
Hatice Akkaya (associate professor, Kayseri Education and Research Hospital) — Sponsor-investigator
First posted
Oct 28, 2021
Start date
May 1, 2020
Primary completion
Dec 15, 2020
Completion
Dec 30, 2020
Last update
Oct 28, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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