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NCT01095315 Clinical Trial

Delayed Positioning in Cesarean Section

Hypotension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01095315
Other study ID # delayed positioning
Secondary ID
Status Completed
Phase N/A
First received March 22, 2010
Last updated April 9, 2010
Start date October 2007
Est. completion date September 2008

Study information
Verified date March 2010
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Maternal hypotension is a common problem during cesarian section under spinal anesthesia. The possible explanation for this is combined aortocaval compression by gravid uterus in parturient in addition to reduced systemic vascular resistance by spinal anesthesia. The investigators evaluated if the incidence of hypotension would be decreased by delayed supine positioning, by maintaining lateral position for 6 min after spinal injection, in patients undergoing elective cesarean section.

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date September 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Female
Age group 28 Years to 44 Years
Eligibility Inclusion Criteria:

- singleton parturients undergoing elective cesarean section

- gestational age over 37 weeks

Exclusion Criteria:

- pregnancy with hypotension

- expecting fetal depression

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• lateral positioning
the lateral position was maintained for 6 min after spinal injection before patients were turned to the supine position

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary hypotension hypotension incidence after intrathecal injection until baby delivery. Monitoring about for 20 minutes after intrathecal injection until delivery (for 20 minutes) Yes
Secondary sensory block level highest sensory block level after intrathecal injection during cesarean section Yes
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