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Completed

NCT Number: NCT04462107

Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery

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

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Key information

Conditions

Cesarean Section

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surveys

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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. 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

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2020
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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