NCT00757484

Brief Summary

The purpose of this study is to establish normal postoperative changes in blood pressure in women undergoing scheduled gynecologic surgery requiring inpatient postoperative care. Also, to establish if there is a difference in normal postoperative blood pressure changes between elderly and non-elderly women undergoing scheduled gynecologic surgery requiring inpatient postoperative care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
528

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

December 17, 2015

Completed
Last Updated

December 17, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

September 19, 2008

Results QC Date

May 27, 2015

Last Update Submit

December 15, 2015

Conditions

Urogynecology

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Underwent Gynecologic Surgery

    491 women were included in analysis. Measure is categorized by the type of surgery.

    January 2007 to January 2008

Secondary Outcomes (3)

  • Percentage of Women With Asymptomatic Hypotension

    1 year

  • Percentage of Participants Undergoing Different Types of Anesthesia

    January 2007 to January 2008

  • Surgical Time

    January 2007 to January 2008

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Gynecologic patients

You may qualify if:

  • Women who underwent scheduled gynecologic surgery requiring inpatient postoperative care between January 2007 - January 2008

You may not qualify if:

  • Women who experienced myocardial infarction, cardiac arrest or failure, pulmonary embolism, infection requiring intravenous antibiotics, intra- or postoperative hemorrhage requiring blood transfusion, renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Results Point of Contact

Title
Dr. Erin Duecy
Organization
University of Rochester Medical Center
erin_duecy@urmc.rochester.edu
585-275-4004

Study Officials

  • Erin Duecy, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 23, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

December 17, 2015

Results First Posted

December 17, 2015

Record last verified: 2015-05

Locations

US(1)