Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery

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

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

Conditions
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Cesarean Section

Intervention / Treatment
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* Other: Surveys


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surveys<br>All participants will complete questionnaires at several time points, ranging from baseline to 3 months post partum. | Other: Surveys<br>* All participants will complete surveys that range in time from baseline to 3 months post partum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Compare opioid consumption post partum | 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 | 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 | 
| 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 | 
| 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 | 
| Compare Edinburgh Postnatal Depression Scale | Edinburgh Postnatal Depression Scale is a 10 item questionnaire to identify women who have postpartum depression | 6 weeks | 
| 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 |