Cesarean SectionNCT04462107
Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery
An observational study of Cesarean Section, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to describe how patients recover after scheduled C-section for the first 3 months. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Surveys
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Parturients scheduled for cesarean delivery at Mayo Clinic Hospital Family Birth Center
Who may be able to join
- Women 18 years of age or older who receive neuraxial anesthesia for elective cesarean delivery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Cesarean Section
- Being tested
- Surveys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
All participants will complete surveys that range in time from baseline to 3 months post partum.
| Study group | Role | What they receive |
|---|---|---|
| Surveys | All participants will complete questionnaires at several time points, ranging from baseline to 3 months post partum. Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal evaluation of global health visual analog scale
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.
Measured: Baseline, 24 h, 48 h, 1 week, 3 weeks, 6 weeks, 12 weeks postpartum
Secondary outcomes (11)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 weeks postpartum
Compare Edinburgh Postnatal Depression Scale
Edinburgh Postnatal Depression Scale is a 10 item questionnaire to identify women who have postpartum depression
Measured: 6 weeks postpartum
Compare a modified recovery after delivery questionnaire
9 questions that ask the mother about feeding baby, sleep, fatigue, bonding, parenting, and social functioning
Measured: 6 weeks postpartum
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.
Measured: 6 weeks postpartum
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.
Measured: 12 weeks postpartum
Correlation between ObsQOR-10 scores at multiple time points
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.
Measured: 24 hours, 48 hours, 1 week postpartum
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.
Measured: 3 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Feb 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily E. Sharpe, M.D., Mayo Clinic
- Investigators
- Emily E Sharpe, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462107
- Sponsor's protocol ID
- 19-012077
- Status last verified
- Jan 2026
- First submitted
- 7 Apr 2020
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sharpe EE, Sviggum HP, Carvalho B, Guo N, Arendt KW, Stoltenberg AD, Tinaglia AG, Torbenson VE, Sultan P. Profiling Postpartum Recovery After Scheduled Cesarean Delivery With Neuraxial Anesthesia: A Longitudinal Cohort Study. Anesth Analg. 2025 Nov 1;141(5):1089-1096. doi: 10.1213/ANE.0000000000007476. Epub 2025 Apr 4.
PubMed 40184308
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study Evaluating Postpartum Recovery After Scheduled Cesarean Delivery With the Obstetric Quality of Recovery Tool
- ClinicalTrials.gov ID
- NCT04462107
- Acronym / sponsor ID
- 19-012077
- Conditions
- Cesarean Section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to describe how patients recover after scheduled C-section for the first 3 months.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surveys | – | Other: SurveysAll participants will complete questionnaires at several time points, ranging from baseline to 3 months post partum. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Parturients scheduled for cesarean delivery at Mayo Clinic Hospital Family Birth Center
Key inclusion criteria (1 listed)
- Women 18 years of age or older who receive neuraxial anesthesia for elective cesarean delivery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysAll participants will complete surveys that range in time from baseline to 3 months post partum. | Other | Surveys |
Primary outcome
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.
11 secondary outcomes
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
Compare opioid consumption post partum
Time frame: 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
Compare frequency of activities of daily living
Time frame: Baseline
Compare frequency of activities of daily living
Time frame: 6 weeks postpartum
Compare Edinburgh Postnatal Depression Scale
Time frame: 6 weeks postpartum
Compare a modified recovery after delivery questionnaire
Time frame: 6 weeks postpartum
Correlation between postpartum ObsQOR-10 and EQ-5D
Time frame: 6 weeks postpartum
Correlation between postpartum ObsQOR-10 and EQ-5D
Time frame: 12 weeks postpartum
Correlation between ObsQOR-10 scores at multiple time points
Time frame: 24 hours, 48 hours, 1 week postpartum
Correlation between postpartum ObsQOR-10 and EQ-5D
Time frame: 3 weeks post partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Derived from this study: PubMed 40184308Sharpe EE, Sviggum HP, Carvalho B, Guo N, Arendt KW, Stoltenberg AD, Tinaglia AG, Torbenson VE, Sultan P. Profiling Postpartum Recovery After Scheduled Cesarean Delivery With Neuraxial Anesthesia: A Longitudinal Cohort Study. Anesth Analg. 2025 Nov 1;141(5):1089-1096. doi: 10.1213/ANE.0000000000007476. Epub 2025 Apr 4.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily E Sharpe, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal evaluation of global health visual analog scale (time frame: Baseline, 24 h, 48 h, 1 week, 3 weeks, 6 weeks, 12 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462107, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.