Incidence and Neonatal Outcome of Eclamptic Parturient in... | NCT04160923

Studies
Incidence and Neonatal Outcome of Eclamptic Parturient in Tertiary Hospital.

NCT04160923

Sponsor

Siriraj Hospital

Status

Completed

Last Update Posted

Nov 15, 2019Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Eclampsia

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Apr 2019Actual

Completion Date

May 2019Actual

First Submitted Date

Nov 10, 2019

First Submission Date that Met QC Criteria

Nov 10, 2019

First Posted Date

Nov 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2019

Last Update Posted Date

Nov 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of eclampsia in Siriraj Hospital.	Incidence represent as percent.	13 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient who diagnosed with eclampsia.

Exclusion Criteria:

Incomplete medical record.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patient who diagnosed with eclampsia during January2005-December 2017

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Soawaphak Chumpathong, Assoc. Prof.	Department of Anesthesiology, Siriraj Hospital, Mahidol University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, Siriraj Hospital, Mahidol University		Bangkok Noi	Bangkok	10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D004461	Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided