Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03054233
• Date of registration: 13/02/2017
• Prospective Registration: No
• Primary sponsor: Indonesia University
• Public title: Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women
• Scientific title: Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women in Crossed Leg Sitting Position Undergoing Caesarean Section
• Date of first enrolment: July 2016
• Target sample size: 136
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03054233
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Indonesia

Contacts

• Name: Susilo Chandra
• Affiliation: Indonesia University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects aged 18-45 years old, with American Society of Anesthesiologists (ASA)
physical status I-III who were planned to undergo caesarian section with spinal
anesthesia in crossed leg sitting position.

- Subjects have been explained about the study, have agreed to enroll and have signed
the informed consent form

Exclusion Criteria:

- Subjects with contraindications for spinal anesthesia

- Subjects with fetal's head trapped, umbilical prolapse, and foot presentation

- Subjects with pre-eclampsia

- Subjects with cardiovascular diseases

- Subjects with scoliosis

- Subjects with recent lumbal surgery history

- Subjects who cannot sit in crossed leg sitting position.

Drop out criteria:

- Subjects with worsening conditions before spinal anesthesia

- Subjects with failed spinal needle insertion and thus received general anesthesia

- Subjects with twin pregnancy

- Subjects drop out the study.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Caesarian Section

Intervention(s)

Procedure: Crossed leg sitting position

Primary Outcome(s)

Number of successful spinal needle placement in the first attempt [Time Frame: 2 months]

The number of needle-bone contact [Time Frame: 2 months]

Secondary Outcome(s)

The number of blood vessel puncture incidence. [Time Frame: 2 months]

Secondary ID(s)

IndonesiaUAnes010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors