Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery

January 26, 2026 updated by: Emily E. Sharpe, M.D., Mayo Clinic

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Longitudinal evaluation of global health visual analog scale
Time Frame: 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.
Baseline, 24 h, 48 h, 1 week, 3 weeks, 6 weeks, 12 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine change in pain levels post C-section using the Visual Analog Scale (VAS)
Time Frame: 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
Baseline, 24 hour, 48 hour, 1 week, 3 weeks, 6 weeks, 12 weeks, and 3 months
Compare opioid consumption post partum
Time Frame: 24 hours, 48 hours, 1 week, 3 weeks, 6 weeks, and 3months 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
Time Frame: 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.
Hospital discharge, approximately 3 days
Compare frequency of activities of daily living
Time Frame: Baseline
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
Time Frame: 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
6 weeks postpartum
Compare Edinburgh Postnatal Depression Scale
Time Frame: 6 weeks postpartum
Edinburgh Postnatal Depression Scale is a 10 item questionnaire to identify women who have postpartum depression
6 weeks postpartum
Compare a modified recovery after delivery questionnaire
Time Frame: 6 weeks postpartum
9 questions that ask the mother about feeding baby, sleep, fatigue, bonding, parenting, and social functioning
6 weeks postpartum
Correlation between postpartum ObsQOR-10 and EQ-5D
Time Frame: 6 weeks postpartum
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.
6 weeks postpartum
Correlation between postpartum ObsQOR-10 and EQ-5D
Time Frame: 12 weeks postpartum
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.
12 weeks postpartum
Correlation between ObsQOR-10 scores at multiple time points
Time Frame: 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.
24 hours, 48 hours, 1 week postpartum
Correlation between postpartum ObsQOR-10 and EQ-5D
Time Frame: 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.
3 weeks post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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