Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery

Longitudinal Study Evaluating Postpartum Recovery After Scheduled Cesarean Delivery With the Obstetric Quality of Recovery Tool

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Other: Surveys

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Parturients scheduled for cesarean delivery at Mayo Clinic Hospital Family Birth Center

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surveys; All participants will complete questionnaires at several time points, ranging from baseline to 3 months post partum.	Other: Surveys; All participants will complete surveys that range in time from baseline to 3 months post partum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Compare opioid consumption post partum	Compare opioid consumption post partum	24 hours, 48 hours, 1 week, 3 weeks, 6 weeks, and 3months post partum
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
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
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
Compare Edinburgh Postnatal Depression Scale	Edinburgh Postnatal Depression Scale is a 10 item questionnaire to identify women who have postpartum depression	6 weeks
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Emily E Sharpe, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19-012077

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No