NCT02472327

Brief Summary

Patient satisfaction after an unplanned cesarean section was studied and in the previous study it was noted that there were common themes that lead to patient dissatisfaction. The four common themes were: lack of trust regarding the indications for surgery, communication issues, loss of control, and fear during the situation. The purpose of this second phase of this study is to try and improve patient dissatisfaction by offering additional emotional support prior to the c/s with the hope of decreasing the trust issues toward physicians, decreasing the communication barriers, and decreasing the fear and loss of control. The additional emotional support that will be received prior to the cesarean section will be scripted based upon the findings of the investigators' prior study - the patient will be asked four questions and each question addresses the four themes that were noted in the previous study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

June 3, 2015

Last Update Submit

January 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    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

Study Arms (2)

Typical Care

NO INTERVENTION

These patients will receive normal peripartum care and support.

Pre-operative support

EXPERIMENTAL

These patients will receive additional emotional support prior to undergoing an unplanned cesarean section during labor.

Behavioral: Pre-operative support

Interventions

Pre-operative support

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant patient admitted at Albany Medical Center
  • Faculty group patient

You may not qualify if:

  • Patients who have scheduled cesarean sections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Paul Burcher MD, PhD

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 15, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations