Trial Outcomes & Findings for Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial (NCT NCT00799292)
NCT ID: NCT00799292
Last Updated: 2018-07-24
Results Overview
COMPLETED
PHASE4
58 participants
Blood loss will be assessed at the end of the operative procedure
2018-07-24
Participant Flow
Enrollment and informed consent was obtained prior to the operation in the gynecology clinic or private offices from 1/2004 - 1/2005.
Randomization occurred at the time of surgery.
Participant milestones
| Measure |
No Injection
Patients did not receive an injection at cervix prior to beginning the procedure.
|
Injection of Vasopressin
Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial
Baseline characteristics by cohort
| Measure |
No Injection
n=29 Participants
Patients did not receive an injection at cervix prior to beginning the procedure.
|
Injection of Vasopressin
n=29 Participants
Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
29 participants
n=107 Participants
|
58 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood loss will be assessed at the end of the operative procedureOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Duration of vaginal hysterectomyEstimated blood loss as mL
Outcome measures
| Measure |
No Injection
n=29 Participants
Patients did not receive an injection at cervix prior to beginning the procedure.
|
Injection of Vasopressin
n=29 Participants
Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
|
|---|---|---|
|
Estimated Blood Loss
|
266.4 mL
Standard Deviation 240.50
|
145.3 mL
Standard Deviation 137.14
|
SECONDARY outcome
Timeframe: Duration of procedures and immediate post-operative stay in hospitalOutcome measures
Outcome data not reported
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Charles Ascher-Walsh MD, MPH
Mt Sinai School of Medicine, Department of Obstetrics and Gynecology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place