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.

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Key information

Conditions

Foot and Ankle Edema Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Observational

Primary location

BC Women's Hospital

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Jun 20, 2007
Registry last updated: Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed