Back to resultsExtra Sitting Time After Spinal Anesthesia for Cesarean Section and Fetal Well-being
Primary Purpose
Complications; Cesarean Section, Hypotension
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Various sitting time
Sponsored by
About this trial
This is an interventional treatment trial for Complications; Cesarean Section
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.
Sites / Locations
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Immediately Supine Position
Delayed Supine Position
Arm Description
Women placed in supine position within 30 seconds after spinal injection of local anesthetic drug.
Women placed in supine position after three minutes of seating after spinal injection of local anesthetic drug.
Outcomes
Primary Outcome Measures
Incidence of fetal umbilical artery pH below 7.20
Secondary Outcome Measures
Incidence of maternal hypotension
Full Information
NCT ID
NCT02893696
First Posted
September 2, 2016
Last Updated
January 29, 2019
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02893696
Brief Title
Extra Sitting Time After Spinal Anesthesia for Cesarean Section and Fetal Well-being
Official Title
The Effect of Sitting After Spinal Injection of Hyperbaric Local Anesthetic on Fetal Acid-base Balance After Cesarean Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
no enrollment
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Cesarean Section, Hypotension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediately Supine Position
Arm Type
Active Comparator
Arm Description
Women placed in supine position within 30 seconds after spinal injection of local anesthetic drug.
Arm Title
Delayed Supine Position
Arm Type
Active Comparator
Arm Description
Women placed in supine position after three minutes of seating after spinal injection of local anesthetic drug.
Intervention Type
Other
Intervention Name(s)
Various sitting time
Intervention Description
Various sitting time
Primary Outcome Measure Information:
Title
Incidence of fetal umbilical artery pH below 7.20
Time Frame
At fetal delivery
Secondary Outcome Measure Information:
Title
Incidence of maternal hypotension
Time Frame
During cesarean surgery
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weike Tao, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extra Sitting Time After Spinal Anesthesia for Cesarean Section and Fetal Well-being
We'll reach out to this number within 24 hrs