Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery
- Conditions
- Cesarean Section
- Interventions
- Other: Surveys
- Registration Number
- NCT04462107
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The purpose of this research is to describe how patients recover after scheduled C-section for the first 3 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 66
- Women 18 years of age or older who receive neuraxial anesthesia for elective cesarean delivery
- Less than 18 years of age
- Gestational age less than 32 weeks
- Women whose infants have died or are in the neonatal intensive care unit after delivery
- Inability to read or understand written English
- Failed neuraxial anesthesia requiring general anesthesia
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Surveys Surveys All participants will complete questionnaires at several time points, ranging from baseline to 3 months post partum.
- Primary Outcome Measures
Name Time Method Longitudinal evaluation of global health visual analog scale Baseline, 24 h, 48 h, 1 week, 3 weeks, 6 weeks, 12 weeks postpartum Global health on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. Plan was to identify the plateau of improvement of GHVAS postpartum.
- Secondary Outcome Measures
Name Time Method To determine change in pain levels post C-section using the Visual Analog Scale (VAS) Baseline, 24 hour, 48 hour, 1 week, 3 weeks, 6 weeks, 12 weeks, and 3 months Describes pain from no pain at all to the worst pain imaginable using a 100mm horizontal line
Compare non-maternal reasons for delayed hospital discharge Hospital discharge, approximately 3 days Document non-maternal reasons for delayed hospital discharge such as NICU admission of neonate, neonatal IV antibiotics, delay in transportation, delay from pediatric team.
Compare frequency of activities of daily living 6 weeks postpartum Activities of daily living are routine activities people do everyday without assistance including eating, bathing, getting dressed, toileting, cooking, cleaning, driving, shopping. Subject will report these activities as not done yet, done once, once/week, do most days, do every day
Correlation between postpartum ObsQOR-10 and EQ-5D 3 weeks post partum EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control.
Compare a modified recovery after delivery questionnaire 6 weeks postpartum 9 questions that ask the mother about feeding baby, sleep, fatigue, bonding, parenting, and social functioning
Compare Edinburgh Postnatal Depression Scale 6 weeks postpartum Edinburgh Postnatal Depression Scale is a 10 item questionnaire to identify women who have postpartum depression
Compare opioid consumption post partum 24 hours, 48 hours, 1 week, 3 weeks, 6 weeks, and 3months post partum Compare opioid consumption post partum
Correlation between ObsQOR-10 scores at multiple time points 24 hours, 48 hours, 1 week postpartum The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States