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Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04462107
Enrollment
66
Registered
2020-07-08
Start date
2021-02-01
Completion date
2021-11-01
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Brief summary

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

Interventions

OTHERSurveys

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

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Longitudinal evaluation of global health visual analog scaleBaseline, 24 h, 48 h, 1 week, 3 weeks, 6 weeks, 12 weeks postpartumGlobal 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

MeasureTime frameDescription
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 monthsDescribes pain from no pain at all to the worst pain imaginable using a 100mm horizontal line
Compare opioid consumption post partum24 hours, 48 hours, 1 week, 3 weeks, 6 weeks, and 3months post partumCompare opioid consumption post partum
Compare non-maternal reasons for delayed hospital dischargeHospital discharge, approximately 3 daysDocument 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 livingBaselineActivities 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
Compare Edinburgh Postnatal Depression Scale6 weeks postpartumEdinburgh Postnatal Depression Scale is a 10 item questionnaire to identify women who have postpartum depression
Compare a modified recovery after delivery questionnaire6 weeks postpartum9 questions that ask the mother about feeding baby, sleep, fatigue, bonding, parenting, and social functioning
Correlation between postpartum ObsQOR-10 and EQ-5D6 weeks postpartumEQ-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.
Correlation between ObsQOR-10 scores at multiple time points24 hours, 48 hours, 1 week postpartumThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREmily E Sharpe, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026