PreeclampsiaONSDNCT04095832
The Effect of Epidural Anesthesia on the Optic Nerve Sheath Diameter in Preeclampsia
An observational study of Preeclampsia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to assess the effect of epidural anesthesia on the optic nerve sheath diameter in parturients with preeclampsia. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Epidural anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Apr 2020to 19 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: We plans to include 11 preeclamptic patients and 11 healthy pregnant women.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Height < 140cm or height > 190cm
- eye disease
- infection or trauma near the eyes
- abnormality of intracranial pressure due to Intracranial pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Epidural Anesthesia on the Optic Nerve Sheath Diameter in Preeclampsia: A Prospective Observational Study
This study aims to assess the effect of epidural anesthesia on the optic nerve sheath diameter in parturients with preeclampsia.
Read the detailed description
This prospective observational study will be performed in parturients, either with or without preeclampsia, who scheduled to undergo elective cesarean delivery under epidural anesthesia. Epidural anesthesia will be done according to the standard technique. Optic nerve sheath diameter (ONSD) will be measured before and after the epidural injection of anesthetic solutions using ultrasonography. The investigators will assess whether epidural anesthesia has effect on optic nerve sheath diameter of pregnant women, and the investigators will also compare ONSD between healthy parturients and parturients with preeclampsia. The investigators will evaluate the relationship between ONSD and disease severity of preeclampsia.
- Conditions
- Preeclampsia
- Being tested
- Epidural anesthesia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural anesthesiaProcedure or surgery
Epidural anesthesia using standardized technique
| Study group | Role | What they receive |
|---|---|---|
| Parturients with preeclampsia | Parturients who were diagnosed with preeclampsia Receives: Procedure: Epidural anesthesia | |
| Healthy parturients | Healthy full-term parturients Receives: Procedure: Epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter (ONSD) after epidural anesthesia
measured by transocular ultrasonography
Measured: 3 minutes after the completion of epidural injection of the anesthetic solutions
Secondary outcomes (19)
Optic nerve sheath diameter (ONSD)
measured by transocular ultrasonography
Measured: 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
blood pressure in mmHg
Measured: on delivery day
Proteinuria
The presence of Proteinuria during the admission period
Measured: during the admission period
Epigastric pain
The occurrence of epigastric pain during the admission period
Measured: during the admission period
Headache
The occurrence of Headache during the admission period
Measured: during the admission period
Visual disturbances
The occurrence of Visual disturbances during the admission period
Measured: during the admission period
Oliguria
The occurrence of Oliguria during the admission period
Measured: during the admission period
eclampsia
The occurrence of seizure during the admission period
Measured: during the admission period
intracranial hemorrhage
The occurrence of intracranial hemorrhage during the admission period
Measured: during the admission period
Serum creatinine
Serum creatinine concentration
Measured: during the admission period
Serum albumin
Serum albumin concentration
Measured: during the admission period
Platelet count
Platelet count measured during the admission period
Measured: during the admission period
AST
AST measured during the admission period
Measured: during the admission period
Apgar Score of fetus
Apgar Score of delivered fetus
Measured: at 1 min, 5 min
Umbilical arterial pH
pH in mmol/L, Umbilical arterial blood gas analysis
Measured: immediately after delivery
ALT
ALT measured during the admission period
Measured: during the admission period
Umbilical arterial base excess
base excess in mmol/L, Umbilical arterial blood gas analysis
Measured: immediately after delivery
Umbilical arterial PO2
PO2 in mmHg, Umbilical arterial blood gas analysis
Measured: immediately after delivery
Umbilical arterial PCO2
PCO2 in mmHg, Umbilical arterial blood gas analysis
Measured: immediately after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start14 Apr 2020
- Primary completion9 May 2023
- Study completion19 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095832
- Sponsor's protocol ID
- 1908-051-1055
- Acronym
- ONSD
- Status last verified
- May 2023
- First submitted
- 16 Sep 2019
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30057149Ortner 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.
PubMed 31094790Park 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.
PubMed 38950931
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Epidural Anesthesia on the Optic Nerve Sheath Diameter in Preeclampsia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04095832
- Acronym / sponsor ID
- ONSD / 1908-051-1055
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the effect of epidural anesthesia on the optic nerve sheath diameter in parturients with preeclampsia.
Detailed description
This prospective observational study will be performed in parturients, either with or without preeclampsia, who scheduled to undergo elective cesarean delivery under epidural anesthesia. Epidural anesthesia will be done according to the standard technique. Optic nerve sheath diameter (ONSD) will be measured before and after the epidural injection of anesthetic solutions using ultrasonography. The investigators will assess whether epidural anesthesia has effect on optic nerve sheath diameter of pregnant women, and the investigators will also compare ONSD between healthy parturients and parturients with preeclampsia. The investigators will evaluate the relationship between ONSD and disease severity of preeclampsia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parturients with preeclampsia | – | Procedure: Epidural anesthesiaParturients who were diagnosed with preeclampsia |
| Healthy parturients | – | Procedure: Epidural anesthesiaHealthy full-term parturients |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We plans to include 11 preeclamptic patients and 11 healthy pregnant women.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- Contraindication to epidural anesthesia
- Morbid cardiovascular disease
- Cerebrovascular disease
- Known fetal anomaly
- Any signs of onset of labor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural anesthesiaEpidural anesthesia using standardized technique | Procedure or surgery | Healthy parturients, Parturients with preeclampsia |
Primary outcome
Optic nerve sheath diameter (ONSD) after epidural anesthesia
Time frame: 3 minutes after the completion of epidural injection of the anesthetic solutions
measured by transocular ultrasonography
19 secondary outcomes
Optic nerve sheath diameter (ONSD)
Time frame: 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
Time frame: on delivery day
Proteinuria
Time frame: during the admission period
Epigastric pain
Time frame: during the admission period
Headache
Time frame: during the admission period
Visual disturbances
Time frame: during the admission period
Oliguria
Time frame: during the admission period
eclampsia
Time frame: during the admission period
intracranial hemorrhage
Time frame: during the admission period
Serum creatinine
Time frame: during the admission period
Serum albumin
Time frame: during the admission period
Platelet count
Time frame: during the admission period
AST
Time frame: during the admission period
Apgar Score of fetus
Time frame: at 1 min, 5 min
Umbilical arterial pH
Time frame: immediately after delivery
ALT
Time frame: during the admission period
Umbilical arterial base excess
Time frame: immediately after delivery
Umbilical arterial PO2
Time frame: immediately after delivery
Umbilical arterial PCO2
Time frame: immediately after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Background: PubMed 30057149Brzan 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.
- Background: PubMed 31094790Ortner 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.
- Derived from this study: PubMed 38950931Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Tae Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter (ONSD) after epidural anesthesia (time frame: 3 minutes after the completion of epidural injection of the anesthetic solutions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095832, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.