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Foot and Ankle Edema Post-Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00488956
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : March 18, 2014
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:

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 or disease
Foot and Ankle Edema

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Foot and Ankle Edema Post-Cesarean Delivery
Study Start Date : June 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women booked for an elective Cesarean delivery will be recruited into the study.

Inclusion Criteria:

  1. Women with a singleton pregnancy;
  2. Undergoing an elective CD under regional anesthesia (spinal or combined spinal epidural (CSE);
  3. Normotensive; and
  4. At least 37 weeks gestation

Exclusion Criteria:

  1. Reasons for potential excessive blood loss (e.g. placenta previa);
  2. Reasons for potential uterine atony and above average use of oxytocin (e.g. multiple pregnancies, polyhydramnios);
  3. Non lower segment uterine incision;
  4. Renal or cardiac disease;
  5. Use of diuretics; or
  6. Open wounds on the right foot and ankle.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00488956

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Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
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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
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Responsible Party: University of British Columbia Identifier: NCT00488956    
Other Study ID Numbers: H07-00540
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014
Keywords provided by University of British Columbia:
Additional relevant MeSH terms:
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