NCT04095832

Brief Summary

This study aims to assess the effect of epidural anesthesia on the optic nerve sheath diameter in parturients with preeclampsia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

April 14, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

3.1 years

First QC Date

September 16, 2019

Last Update Submit

May 25, 2023

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • Optic nerve sheath diameter (ONSD) after epidural anesthesia

    measured by transocular ultrasonography

    3 minutes after the completion of epidural injection of the anesthetic solutions

Secondary Outcomes (19)

  • Optic nerve sheath diameter (ONSD)

    before epidural anesthesia, 10, 20 minutes after the completion of epidural injection of the anesthetic solutions, 10 minutes after delivery of fetus, at the end of surgery.

  • Blood pressure

    on delivery day

  • Proteinuria

    during the admission period

  • Epigastric pain

    during the admission period

  • Headache

    during the admission period

  • +14 more secondary outcomes

Study Arms (2)

Parturients with preeclampsia

Parturients who were diagnosed with preeclampsia

Procedure: Epidural anesthesia

Healthy parturients

Healthy full-term parturients

Procedure: Epidural anesthesia

Interventions

Epidural anesthesiaPROCEDURE

Epidural anesthesia using standardized technique

Healthy parturientsParturients with preeclampsia

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We plans to include 11 preeclamptic patients and 11 healthy pregnant women.

You may qualify if:

  • Patients scheduled to undergo planned cesarean section under epidural anesthesia if they have a singleton pregnancy, complicated by severe preeclampsia.
  • Severe preeclampsia was defined using the American College of Obstetricians and Gynecologist Task Force on Hypertension in Pregnancy recommendations
  • Controls will be healthy pregnant women at term (\>37 weeks), with a singleton pregnancy, no signs or symptoms of preeclampsia and no intrauterine fetal growth restriction, who are planned to undergo elective cesarean delivery under epidural anesthesia

You may not qualify if:

  • Contraindication to epidural anesthesia
  • Morbid cardiovascular disease
  • Cerebrovascular disease
  • Known fetal anomaly
  • Any signs of onset of labor
  • Body weight \< 40 kg or body weight \> 100 kg
  • Height \< 140cm or height \> 190cm
  • eye disease
  • infection or trauma near the eyes
  • abnormality of intracranial pressure due to Intracranial pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (3)

  • Brzan Simenc G, Ambrozic J, Prokselj K, Tul N, Cvijic M, Mirkovic T, Lucovnik M. Ocular ultrasonography for diagnosing increased intracranial pressure in patients with severe preeclampsia. Int J Obstet Anesth. 2018 Nov;36:49-55. doi: 10.1016/j.ijoa.2018.06.005. Epub 2018 Jul 4.

    PMID: 30057149BACKGROUND

  • Ortner CM, Krishnamoorthy V, Neethling E, Flint M, Swanevelder JL, Lombard C, Fawcus S, Dyer RA. Point-of-Care Ultrasound Abnormalities in Late-Onset Severe Preeclampsia: Prevalence and Association With Serum Albumin and Brain Natriuretic Peptide. Anesth Analg. 2019 Jun;128(6):1208-1216. doi: 10.1213/ANE.0000000000003759.

    PMID: 31094790BACKGROUND

  • Park SK, Kim H, Kim Y, Jang YE, Kim JT. Effect of epidural anesthesia on the optic nerve sheath diameter in patients with pre-eclampsia: a prospective observational study. Reg Anesth Pain Med. 2025 Oct 6;50(10):828-834. doi: 10.1136/rapm-2024-105444.

    PMID: 38950931DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Jin-Tae Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 19, 2019

Study Start

April 14, 2020

Primary Completion

May 9, 2023

Study Completion

May 19, 2023

Last Updated

May 30, 2023

Record last verified: 2023-05

Locations

KR(1)