NCT01095315

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
Last Updated

April 12, 2010

Status Verified

March 1, 2010

Enrollment Period

9 months

First QC Date

March 22, 2010

Last Update Submit

April 9, 2010

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

  • hypotension

    hypotension incidence after intrathecal injection until baby delivery. Monitoring about for 20 minutes

    after intrathecal injection until delivery (for 20 minutes)

Secondary Outcomes (1)

  • sensory block level

    during cesarean section

Study Arms (2)

standard

NO INTERVENTION

parturients were placed back to the supine position immediately after spinal injection following standard protocol of spinal anesthesia

lateral

EXPERIMENTAL

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

Other: lateral positioning

Interventions

lateral positioningOTHER

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

lateral

Eligibility Criteria

Age28 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • pregnancy with hypotension
  • expecting fetal depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2010

First Posted

March 30, 2010

Study Start

October 1, 2007

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

April 12, 2010

Record last verified: 2010-03