Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 9:29 PM
Study NCT ID:
NCT03054233
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2017-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women
Sponsor:
Indonesia University
Organization:
Study Overview
Official Title:
Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women in Crossed Leg Sitting Position Undergoing Caesarean Section
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aimed to compare successful spinal needle insertion between obese and non-obese pregnant women in crossed leg sitting position undergoing cesarean section
Detailed Description:
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study.Subjects sat in cross leg sitting position: patients sit with both thighs abducted, knees flexed medially, each feet soles were under their contralateral thighs. The back was flexed maximally, subjects' chin approaching the sternum, and subjects hugged a pillow. Lumbal puncture was done using Quincke needle 25G/27G at L4-5 intervertebral gap until the it reached subarachnoid space (confirmed by free flow cerebrospinal fluid). Data recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and blood vessel puncture incidence. Data was analyzed by using Statistical Package for Social Scientist (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p\<0.05.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: