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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04462107
Other study ID # 19-012077
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date November 1, 2021

Study information

Verified date May 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this research is to describe how patients recover after scheduled C-section for the first 3 months.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 1, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Women 18 years of age or older who receive neuraxial anesthesia for elective cesarean delivery Exclusion Criteria: - 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


Related Conditions & MeSH terms


Intervention

Other:
Surveys
All participants will complete surveys that range in time from baseline to 3 months post partum.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between postpartum ObsQOR-10 and EQ-5D 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. r cesarean delivery and at 6 weeks post partum. Baseline
Primary Correlation between postpartum ObsQOR-10 and EQ-5D 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. r cesarean delivery and at 6 weeks post partum. post partum=24 hours
Primary Correlation between postpartum ObsQOR-10 and EQ-5D 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. r cesarean delivery and at 6 weeks post partum. 48 hours post partum
Primary Correlation between postpartum ObsQOR-10 and EQ-5D 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. r cesarean delivery and at 6 weeks post partum. 1 week post partum
Primary Correlation between postpartum ObsQOR-10 and EQ-5D 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. r cesarean delivery and at 6 weeks post partum. 3 weeks post partum
Primary Correlation between postpartum ObsQOR-10 and EQ-5D 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. r cesarean delivery and at 6 weeks post partum. 6 weeks post partum
Primary Correlation between postpartum ObsQOR-10 and EQ-5D 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. r cesarean delivery and at 6 weeks post partum. 3 months post partum
Secondary To determine change in pain levels post C-section using the Visual Analog Scale (VAS) Describes pain from no pain at all to the worst pain imaginable using a 100mm horizontal line Baseline, 24 hour, 48 hour, 1 week, 3 weeks, 6 weeks, 12 weeks, and 3 months
Secondary Compare opioid consumption post partum Compare opioid consumption post partum 24 hours, 48 hours, 1 week, 3 weeks, 6 weeks, and 3months post partum
Secondary Compare non-maternal reasons for delayed hospital discharge Document non-maternal reasons for delayed hospital discharge such as NICU admission of neonate, neonatal IV antibiotics, delay in transportation, delay from pediatric team. Hospital discharge, approximately 3 days
Secondary Compare frequency of activities of daily living 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 Baseline
Secondary Compare frequency of activities of daily living 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 6 weeks
Secondary Compare Edinburgh Postnatal Depression Scale Edinburgh Postnatal Depression Scale is a 10 item questionnaire to identify women who have postpartum depression 6 weeks
Secondary Compare a modified recovery after delivery questionnaire 9 questions that ask the mother about feeding baby, sleep, fatigue, bonding, parenting, and social functioning 6 weeks
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