Foot and Ankle Edema Post-Cesarean Delivery
Recruitment status was Active, not recruiting
|First Received Date ICMJE||June 18, 2007|
|Last Updated Date||September 28, 2011|
|Start Date ICMJE||June 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00488956 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Foot and Ankle Edema Post-Cesarean Delivery|
|Official Title ICMJE||Foot and Ankle Edema Post-Cesarean Delivery|
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Retrospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Probability Sample|
Pregnant women booked for an elective Cesarean delivery will be recruited into the study.
|Condition ICMJE||Foot and Ankle Edema|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||30|
|Estimated Completion Date||December 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Canada|
|NCT Number ICMJE||NCT00488956|
|Other Study ID Numbers ICMJE||H07-00540|
|Has Data Monitoring Committee||No|
|Responsible Party||University of British Columbia|
|Study Sponsor ICMJE||University of British Columbia|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of British Columbia|
|Verification Date||September 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP