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Delayed Positioning in Cesarean Section

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ClinicalTrials.gov Identifier: NCT01095315
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : April 12, 2010
Sponsor:
Information provided by:
Seoul National University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Hypotension Other: lateral positioning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: standard
parturients were placed back to the supine position immediately after spinal injection following standard protocol of spinal anesthesia
Experimental: lateral
the lateral position was maintained for 6 min after spinal injection before patients were turned to the supine position
Other: lateral positioning
the lateral position was maintained for 6 min after spinal injection before patients were turned to the supine position




Primary Outcome Measures :
  1. hypotension [ Time Frame: after intrathecal injection until delivery (for 20 minutes) ]
    hypotension incidence after intrathecal injection until baby delivery. Monitoring about for 20 minutes


Secondary Outcome Measures :
  1. sensory block level [ Time Frame: during cesarean section ]
    highest sensory block level after intrathecal injection



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Ages Eligible for Study:   28 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • singleton parturients undergoing elective cesarean section
  • gestational age over 37 weeks

Exclusion Criteria:

  • pregnancy with hypotension
  • expecting fetal depression

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Responsible Party: Jung-Won Hwang, Seoul National University Bundan Hospital
ClinicalTrials.gov Identifier: NCT01095315     History of Changes
Other Study ID Numbers: delayed positioning
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: April 12, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases