Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery

NCT04462107 | Completed

• 1 other identifier: 19-012077
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline, 24 hour, 48 hour, 1 week, 3 weeks, 6 weeks, 12 weeks, and 3 months

• 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

  Hospital discharge, approximately 3 days

• Compare frequency of activities of daily living

  Baseline

• Compare frequency of activities of daily living

  6 weeks postpartum

Study Arms (1)

Surveys

All participants will complete questionnaires at several time points, ranging from baseline to 3 months post partum.

Other: Surveys

Interventions

Surveys OTHER

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

Surveys

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women whom are pregnant and will have a scheduled C-section to deliver infant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Women 18 years of age or older who receive neuraxial anesthesia for elective cesarean delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 40184308 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Emily E Sharpe, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: July 8, 2020
• Study Start: February 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)