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NCT02893696 Clinical Trial

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

Hypotension Clinical Trial

Official title:
The Effect of Sitting After Spinal Injection of Hyperbaric Local Anesthetic on Fetal Acid-base Balance After Cesarean Delivery

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02893696
Other study ID # STU012016-059
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 2018
Est. completion date April 2020

Study information
Verified date January 2019
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2020
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Various sitting time
Various sitting time

Locations
Country Name City State
United States University of Texas Southwestern Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of fetal umbilical artery pH below 7.20 At fetal delivery
Secondary Incidence of maternal hypotension During cesarean surgery
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