Delayed Positioning in Cesarean Section

April 9, 2010 updated by: Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 44 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy with hypotension
  • expecting fetal depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypotension
Time Frame: after intrathecal injection until delivery (for 20 minutes)
hypotension incidence after intrathecal injection until baby delivery. Monitoring about for 20 minutes
after intrathecal injection until delivery (for 20 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensory block level
Time Frame: during cesarean section
highest sensory block level after intrathecal injection
during cesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (ESTIMATE)

March 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 12, 2010

Last Update Submitted That Met QC Criteria

April 9, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • delayed positioning

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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