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University of British Columbia |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00488956 |
Some women develop swollen feet and ankles after a cesarean delivery. These women will often complain that their shoes are too tight and their feet may become numb or they may have some tingling in their feet.
Currently we do not know for sure that foot swelling occurs after a cesarean delivery and if it does what the cause is.
If we find that feet do swell after a cesarean delivery we may be able to suggest a cause. This may in the future prevent women developing excessive foot swelling.
We aim to investigate whether the size and shape of women's ankles do change following an elective cesarean delivery. We plan to investigate, if possible, the cause of any foot swelling after a cesarean whether it be the volume of intra venous fluids or oxytocin use.
Condition |
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Foot and Ankle Edema |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | Foot and Ankle Edema Post-Cesarean Delivery |
Estimated Enrollment: | 30 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | December 2008 |
Pregnant women booked for an elective Cesarean delivery will be recruited into the study. Their foot volumes, based on volumetry, and foot and ankle circumferences will be measured prior to administration of IV fluids and then at 24 and 48 hours post delivery. They will also be questioned about their feet with regards to swelling, any symptoms of edema, and their mobility in the preceding two hours. Total fluid balance for the first 24 hours post delivery will be calculated, using the estimated blood loss in the OR, urine output, IV hydration and oral intake. The amount of oxytocin used will also be recorded. The parturient will be asked to fill in a form indicating the amount of oral fluid consumed in the first 24 hours post delivery. Information in the anaesthetic technique, height of block, use of vasopressors etc will be collected retrospectively from the anesthetic chart.
To reduce the chance of the caregivers altering their practice during the study, the attending anesthesiologist for the elective cesarean delivery will be unaware of the subject's participation in the study so that the IV fluids he or she gives will be as close to real practice as possible.
Current practice for IV start and infusion in the surgical daycare area will be used during the study period without modification.
Validation and reproducibility will also be investigated. Each investigator will measure the volume and circumference of the same limb 10 times and inter and intra tester reliability will be calculated.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Pregnant women booked for an elective Cesarean delivery will be recruited into the study.
Inclusion Criteria:
Exclusion Criteria:
Canada, British Columbia | |
BC Women's Hospital | |
Vancouver, British Columbia, Canada |
Principal Investigator: | Roanne Preston, MD | University of British Columbia |
Study Director: | Elizabeth Drake, MD | University of British Columbia |
Study Director: | Joanne Douglas, MD | University of British Columbia |
Responsible Party: | University of British Columbia ( Dr. Roanne Preston ) |
Study ID Numbers: | H07-00540 |
Study First Received: | June 18, 2007 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00488956 History of Changes |
Health Authority: | Canada: Health Canada |
foot ankle edema |
Signs and Symptoms Edema |
Signs and Symptoms Edema |