NCT05098691

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

October 16, 2021

Last Update Submit

October 16, 2021

Conditions

Keywords

early onset preeclampsianectin-4advers pregnancy outcomehypertansion

Outcome Measures

Primary Outcomes (1)

  • serum nectin-4 levels

    ng/ml

    1 hour

Secondary Outcomes (2)

  • BMI (body mass index)

    5 minute

  • Tansion Arterial

    5 minute

Study Arms (2)

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

serum marker levelsDIAGNOSTIC_TEST

two groups comparisons

Group 1 (Early onset Preeclampsia )Group 2 ( Healthy pregnant woman) control group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatice Akkaya

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

October 16, 2021

First Posted

October 28, 2021

Study Start

May 1, 2020

Primary Completion

December 15, 2020

Study Completion

December 30, 2020

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

If needed

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
1 year
Access Criteria
journals editors request

Locations