NCT04004897

Brief Summary

Severe preeclampsia is associated with an elevation in intracranial pressure (ICP). Optic nerve sheath diameter is a non-invasive surrogate of invasive ICP measurement. This study targets to evaluate the ICP in patients with or without preeclampsia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

June 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

June 30, 2019

Last Update Submit

February 19, 2020

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

  • ICP

    The difference in ICP estimated with optic nerve sheath diameter measurement among women with or without preeclampsia

    At 6th hour of admission

Study Arms (2)

Preeclampsia group

OTHER

Patients with preeclampsia will receive optic nerve sheath diameter measurement with a linear ultrasound probe carefully and gently placed on the closed upper eyelids of patients.

Diagnostic Test: Optic nerve sheath diameter measurement

Pregnants without preeclampsia

OTHER

Pregnant women without preeclampsia will receive optic nerve sheath diameter measurement with a linear ultrasound probe carefully and gently placed on the closed upper eyelids of patients.

Diagnostic Test: Optic nerve sheath diameter measurement

Interventions

Optic nerve sheath diameter measurementDIAGNOSTIC_TEST

Optic nerve sheath diameter measurement is performed with a linear ultrasound probe placed over the eyelid.

Preeclampsia groupPregnants without preeclampsia

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must be diagnosed as preeclampsia
  • Age must be \> 18 years

You may not qualify if:

  • History of previous intracranial pathology or surgery
  • Glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, 34005, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Huseyin Kiyak, MD

    Kanuni Sultan Suleyman Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, M.D.

Study Record Dates

First Submitted

June 30, 2019

First Posted

July 2, 2019

Study Start

July 5, 2019

Primary Completion

November 20, 2019

Study Completion

November 25, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)