Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04462107
• Other study ID #: 19-012077
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: May 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. r cesarean delivery and at 6 weeks post partum.	Baseline
Primary	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. r cesarean delivery and at 6 weeks post partum.	post partum=24 hours
Primary	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. r cesarean delivery and at 6 weeks post partum.	48 hours post partum
Primary	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. r cesarean delivery and at 6 weeks post partum.	1 week post partum
Primary	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. r cesarean delivery and at 6 weeks post partum.	3 weeks post partum
Primary	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. r cesarean delivery and at 6 weeks post partum.	6 weeks post partum
Primary	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. r cesarean delivery and at 6 weeks post partum.	3 months post partum
Secondary	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	Baseline, 24 hour, 48 hour, 1 week, 3 weeks, 6 weeks, 12 weeks, and 3 months
Secondary	Compare opioid consumption post partum	Compare opioid consumption post partum	24 hours, 48 hours, 1 week, 3 weeks, 6 weeks, and 3months post partum
Secondary	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.	Hospital discharge, approximately 3 days
Secondary	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	Baseline
Secondary	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	6 weeks
Secondary	Compare Edinburgh Postnatal Depression Scale	Edinburgh Postnatal Depression Scale is a 10 item questionnaire to identify women who have postpartum depression	6 weeks
Secondary	Compare a modified recovery after delivery questionnaire	9 questions that ask the mother about feeding baby, sleep, fatigue, bonding, parenting, and social functioning	6 weeks

External Links

•   Mayo Clinic Clinical Trials