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NCT01393704 · ClinicalTrials.gov registry record · Phase 4
Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial
A Phase 4 study of Blood Loss, Surgical, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 152
- Enrollment target
- 1
- Study location
NCT01393704: Completed Phase 4 study of Blood Loss, Surgical, sponsored by Brigham and Women's Hospital.
NCT01393704 is a Phase 4 study of Blood Loss, Surgical that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 152 participants, above the 111-participant average among 6 other Blood Loss, Surgical trials with a reported enrollment target (37% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01393704, a Phase 4 study of Blood Loss, Surgical, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 152 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this study is to compare blood loss at the time of laparoscopic or robotically-assisted laparoscopic myomectomy when using different amounts of dilute vasopressin solution. Myomectomy is a surgical procedure to remove fibroids from the uterus. Vasopressin is a synthetic drug used to help decrease blood loss at the time of gynecologic surgery; although very little is know about the optimal dosage and administration. The investigators plan to perform a randomized clinical trial on patients scheduled for minimally invasive myomectomy. All patients will get the same overall amount of vasopressin. Patients will be assigned by chance to one of two groups: one group will receive higher volume of a more dilute vasopressin solution. The other group will receive a lower volume of a more concentrated solution. The investigators will collect information on operative blood loss and complications related to surgery.
Primary Outcome
To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Pre and post-operative hematocrit change (%) was one of these measurement methods.
Conditions Studied
Interventions
- DRUG Vasopressin
Study Locations (1)
Massachusetts
- Brigham&Women's hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
What the finished NCT01393704 record still lists
NCT01393704 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 111-participant average among 6 other Blood Loss, Surgical trials with a reported enrollment target (37% higher).
The record links to 1 condition, with Blood Loss, Surgical appearing as the primary indexed condition, and to 1 intervention - of which Vasopressin is the first listed.
NCT01393704 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01393704 about?
NCT01393704 is a clinical study titled "Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial". The main purpose of this study is to compare blood loss at the time of laparoscopic or robotically-assisted laparoscopic myomectomy when using different amounts of dilute vasopressin solution. Myomectomy is a surgical procedure to remove fibroids from the uterus. Vasopressin is a synthetic drug used...
What is the current status of trial NCT01393704?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 152 participants. The study started on 2011-07. Estimated completion is 2015-06.
What conditions does trial NCT01393704 study?
This clinical trial studies the following conditions: Blood Loss, Surgical.
What interventions are being tested in trial NCT01393704?
The interventions under investigation include: Vasopressin (DRUG).
Who is sponsoring clinical trial NCT01393704?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01393704 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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