EclampsiaNCT04160923
Incidence and Neonatal Outcome of Eclamptic Parturient in Tertiary Hospital.
An observational study of Eclampsia, run by Siriraj Hospital at 2 sites in Thailand.
Trial summary
Eclampsia is a rare but serious disease that can happen during the pregnancy. Both general and regional anesthesia can both be performed in eclamptic patients. Eclamptic patients has greater risk if undergo general anesthesia such as risks associated with general anesthesia in pregnancy and also cerebral hemorrhage… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eclampsia
- How many people
- 46 participants
- Where
- 2 sitesThailand
- Study dates
- May 2016to May 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patient who diagnosed with eclampsia during January2005-December 2017
Who may be able to join
- Patient who diagnosed with eclampsia.
Who cannot join
- Incomplete medical record.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Department of Anesthesiology, Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Pattrapun Wongsripuemtet
Bangkok Noi, Bangkok, 10700
About this study
Official title: Incidence and Neonatal Outcome of Eclamptic Parturient : a 13-years Retrospective Study From a Single Tertiary Care Center Anesthetic Aspect.
Eclampsia is a rare but serious disease that can happen during the pregnancy. Both general and regional anesthesia can both be performed in eclamptic patients. Eclamptic patients has greater risk if undergo general anesthesia such as risks associated with general anesthesia in pregnancy and also cerebral hemorrhage risks from hypertension during laryngoscope application and thrombocytopenia that can happen in eclamptic patients. So, most of Anesthesiologists tend to avoid performing general anesthesia in these patients. But spinal anesthesia also has side effects such as hypotension or epidural hematoma. And nowadays there's minimal evidence on suitable anesthesia in eclamptic patients. Our study wants to review on how choice of anesthesia affects these patients both mothers and their neonates
- Conditions
- Eclampsia
- Medical subject headings
- Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of eclampsia in Siriraj Hospital.
Incidence represent as percent.
Measured: 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study startMay 2016
- Primary completionApr 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EclampsiaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pattrapun Wongsripuemtet, Siriraj Hospital
- Investigators
- Soawaphak Chumpathong, Assoc. Prof., Study director, Department of Anesthesiology, Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160923
- Sponsor's protocol ID
- SIRB 390/2017
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Neonatal Outcome of Eclamptic Parturient : a 13-years Retrospective Study From a Single Tertiary Care Center Anesthetic Aspect.
- ClinicalTrials.gov ID
- NCT04160923
- Acronym / sponsor ID
- SIRB 390/2017
- Conditions
- Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 13 Nov 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.
Eclampsia is a rare but serious disease that can happen during the pregnancy. Both general and regional anesthesia can both be performed in eclamptic patients. Eclamptic patients has greater risk if undergo general anesthesia such as risks associated with general anesthesia in pregnancy and also cerebral hemorrhage risks from hypertension during laryngoscope application and thrombocytopenia that can happen in eclamptic patients. So, most of Anesthesiologists tend to avoid performing general anesthesia in these patients. But spinal anesthesia also has side effects such as hypotension or epidural hematoma. And nowadays there's minimal evidence on suitable anesthesia in eclamptic patients. Our study wants to review on how choice of anesthesia affects these patients both mothers and their neonates
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who diagnosed with eclampsia during January2005-December 2017
Key inclusion criteria (1 listed)
- Patient who diagnosed with eclampsia.
Key exclusion criteria (1 listed)
- Incomplete medical record.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of eclampsia in Siriraj Hospital.
Time frame: 13 years
Incidence represent as percent.
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 15 Nov 2019.
Related trials for Eclampsia
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
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.
Soawaphak Chumpathong, Assoc. Prof. study director
Department of Anesthesiology, Siriraj Hospital, Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eclampsia, run by Siriraj Hospital at 2 sites in Thailand.
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 1 inclusion and 1 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 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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?
The incidence of eclampsia in Siriraj Hospital. (time frame: 13 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2019.