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Foot and Ankle Edema Post-Cesarean Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00488956
First received: June 18, 2007
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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
Foot and Ankle Edema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Foot and Ankle Edema Post-Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Enrollment: 35
Study Start Date: June 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders 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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488956

Locations
Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00488956     History of Changes
Other Study ID Numbers: H07-00540
Study First Received: June 18, 2007
Last Updated: March 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
foot
ankle
edema

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014