Beachwood, Ohio 44122

  • Myoma

Purpose:

The goal of the investigators study is to evaluate the effectiveness of paracervical injection of vasopressin at the time of abdominal myomectomy to decrease blood loss. The investigators will continue to use intramyometrial vasopressin as this has previously been shown to be effective. The study will not exceed the safely documented dose of vasopressin.


Study summary:

After the initial physician consultation and investigations have been completed, the treatment options will be reviewed with the patient. If the patient chooses to proceed with an abdominal myomectomy, then she will be offered participation in the study. If she chooses to participate, the patient will undergo routine pre-operative assessments including either transvaginal ultrasound or pelvic MRI. The pre-operative hemoglobin level will be measured within at least 2 weeks of the operative procedure. Randomization to either the vasopressin group or the placebo group will be carried out in the operating room by assigning each recruited patient a consecutively numbered, sealed opaque envelope, which will contain the designated treatment as determined by a computer-generated series of random numbers. The randomization will be performed by an independent member of the division that is not involved in the study. At the time of induction of anesthesia, a sealed envelope will be opened by the research fellow. At the time of induction of anesthesia, the sealed envelope will be opened to reveal the randomization to only the research fellow. The attending physician will remain blinded. The research fellow will prepare either the placebo solution or the vasopressin and will be responsible for performing the paracervical injection. The attending physician will be responsible for recording the surgeon rate of bleeding, the total ebl, and the total operating time. In the both groups, one vial (20 units) of vasopressin will be diluted to 40mL with normal saline solution. Not more than 16mL (8units) of vasopressin will be used. This dose was chosen as there is no standard vasopressin dose routinely used. The dose is well below the maximum amount of vasopressin used, and at a level that few complications have been seen in the past. Given it is standard practice for all patients to receive intramyometrial vasopressin injections, both groups will have the medication ordered and prepared. In the patients randomized to paracervical vasopressin, 8mL (4mL per side of the cervix) will be injected using a 22F spinal needle. An additional 8mL (4 units) will be injected in intramyometrial as this is standard of care in our practice. In the patients randomized to no paracervical vasopressin, 16mL (8 units) will then be used to inject vasopressin intramyometrial prior to the myomectomy. This will help determine if the routine of delivery of vasopressin will aid in decreased blood loss. The operative case will otherwise proceed in the standard fashion. The total ebl, total operative time, and myomectomy operative time will all be recorded. The myomectomy operative time will be recorded from the time of the first incision on the uterus, to complete closure of any uterine defects.


Criteria:

Inclusion Criteria: - Age 18-60 years old - All women who are candidates for abdominal myomectomy and are willing to accept randomization Exclusion Criteria: - Patients unable to consent for the study - Suspected malignancy - History of adverse reaction or allergy to vasopressin - Active cardiovascular or pulmonary disease that would indicate a contraindication to use of vasopressin


Study is Available At:


Original ID:

043231


NCT ID:

NCT02377492


Secondary ID:


Study Acronym:


Brief Title:

Paracervical Vasopressin Injection Compared With Intramyometrial Vasopressin in Abdominal Myomectomy


Official Title:

Paracervical Vasopressin Injection Compared With Intramyometrial Vasopressin in Abdominal Myomectomy: A Randomized Controlled Trial


Overall Status:

Not yet recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University Hospital Case Medical Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Single


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Gretchen Collins, MD
216-285-5028

Study Dates

Start Date:March 2015
Primary Completion Date:March 2017
Primary Completion Type:Anticipated
Verification Date:February 2015
Last Changed Date:March 2, 2015
First Received Date:February 25, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Total operation time (time from incision to end of surgery)
Time Frame:1 day
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Peri-operative complications
Time Frame:2 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in Hgb and Hct post-operatively from pre-operative level
Time Frame:1- 2 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:1. Estimating blood loss at the end of myomectomy (calculated as [total suction canister volume] +[laparotomy pads] - [volume of irritation used] - [volume of vasopressin used])
Time Frame:1 day
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Vasopressins
Description:Either paracervical and intramyometrial or intramyometrial alone at time of abdominal myomectomy.
Arm Name:Paracervical & Intramyometrial
Other Name:vasopressin

Study Arms

Study Arm Type:Active Comparator
Arm Name:Intramyometrial
Description:Vasopressin will be placed intramyometrial (16mL, 8 units)
Study Arm Type:Experimental
Arm Name:Paracervical & Intramyometrial
Description:Vasopressin will be placed paracervically (8mL, 4 units) and intramyometrial (8mL, 4 units)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University Hospital Case Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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