- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02472327
Decreasing Patient Dissatisfaction With Unplanned Cesarean Sections
Decreasing Patient Dissatisfaction With Unplanned Cesarean Sections: A Prospective Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients admitted to the Labor and Delivery unit at Albany Medical College who are in labor or being evaluated for possible indicated delivery will receive information regarding the study. Those who consent to participation, if they are then determined to need a cesarean birth will be randomized into two groups. The first group will receive pre-operative counseling by the obstetrics resident who will be performing the cesarean, the second group will receive usual care. The counseling sheet was determined based upon the findings of a previous study done at this institution, and addresses four themes that were recurrent aspects of patient dissatisfaction after cesarean birth: poor communication, trust of physicians, loss of control, and fear of surgery.
Two weeks after the cesarean section, patients participating in the study are called on the phone by one of the investigators. A patient satisfaction survey, using a Likert scale is administered. This investigator is blinded as to whether the patient has received the additional counseling or not. Comparison of these scores will be used to determine whether pre-operative counseling can reduce dissatisfaction in patients undergoing unplanned cesarean sections.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Albany, New York, United States, 12208
- Albany Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- pregnant patient admitted at Albany Medical Center
- Faculty group patient
Exclusion Criteria:
--Patients who have scheduled cesarean sections
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Typical Care
These patients will receive normal peripartum care and support.
|
|
|
Experimental: Pre-operative support
These patients will receive additional emotional support prior to undergoing an unplanned cesarean section during labor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: 2 weeks postpartum
|
Two weeks postpartum study subjects will participate in a patient satisfaction survey, using a phone interview, and a quantitative Likert scale to determine whether pre-operative counseling improves patient satisfaction scores.
|
2 weeks postpartum
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AlbanyMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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