Extra Sitting Time After Spinal Anesthesia for Cesarean S... | NCT02893696

Studies
Extra Sitting Time After Spinal Anesthesia for Cesarean Section and Fetal Well-being

NCT02893696

Sponsor

University of Texas Southwestern Medical Center

Status

Withdrawn

Last Update Posted

Jan 31, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Complications; Cesarean Section
Hypotension

Interventions

Various sitting time

Countries

United States

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no enrollment

Expanded Access Info

Start Date

Mar 2018Estimated

Primary Completion Date

Mar 2019Estimated

Completion Date

Apr 2020Estimated

First Submitted Date

Sep 2, 2016

First Submission Date that Met QC Criteria

Sep 7, 2016

First Posted Date

Sep 8, 2016Estimated

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

Jan 29, 2019

Last Update Posted Date

Jan 31, 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

After injection of the spinal anesthetic drug, women will be allowed to lie down immediately (0-30 sec) or after three minutes (180 sec) of sitting. The incidence of maternal hypotension and fetal umbilical cord blood pH will be recorded.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediately Supine Position	Active Comparator	Women placed in supine position within 30 seconds after spinal injection of local anesthetic drug.	Other: Various sitting time
Delayed Supine Position	Active Comparator	Women placed in supine position after three minutes of seating after spinal injection of local anesthetic drug.	Other: Various sitting time

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Various sitting time	Other	Various sitting time	Delayed Supine Position Immediately Supine Position

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of fetal umbilical artery pH below 7.20		At fetal delivery

Secondary Outcomes

Measure	Description	Time Frame
Incidence of maternal hypotension		During cesarean surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with elective cesarean delivery at 39-42 wks gestation.

Exclusion Criteria:

Women who shorter than 5'0" in height, those with primary or pregnancy-induced hypertension, macrosomia, multiple gestation will be excluded.
Women with known risks of bleeding or potential hysterectomy such as those with placenta previa or accrete will also be excluded.
If the epidural catheter cannot be placed within the specific time frame after the spinal injection, the case will be excluded.

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Weike Tao, MD	University of Texas Southwestern Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Southwestern Medical Center		Dallas	Texas	75390	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided