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Paracervical Vasopressin Injection Compared With Intramyometrial Vasopressin in Abdominal Myomectomy

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ClinicalTrials.gov Identifier: NCT02377492
Recruitment Status : Unknown
Verified February 2015 by Gretchen Collins, University Hospitals Cleveland Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Gretchen Collins, University Hospitals Cleveland Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myoma Drug: Vasopressins Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Paracervical Vasopressin Injection Compared With Intramyometrial Vasopressin in Abdominal Myomectomy: A Randomized Controlled Trial
Study Start Date : March 2015
Estimated Primary Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids

Arm Intervention/treatment
Experimental: Paracervical & Intramyometrial
Vasopressin will be placed paracervically (8mL, 4 units) and intramyometrial (8mL, 4 units)
Drug: Vasopressins
Either paracervical and intramyometrial or intramyometrial alone at time of abdominal myomectomy.
Other Name: vasopressin

Active Comparator: Intramyometrial
Vasopressin will be placed intramyometrial (16mL, 8 units)
Drug: Vasopressins
Either paracervical and intramyometrial or intramyometrial alone at time of abdominal myomectomy.
Other Name: vasopressin




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in Hgb and Hct post-operatively from pre-operative level [ Time Frame: 1- 2 days ]
  2. Peri-operative complications [ Time Frame: 2 days ]
  3. Total operation time (time from incision to end of surgery) [ Time Frame: 1 day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377492


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

Locations
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United States, Ohio
University Hospitals Fertility Center
Beachwood, Ohio, United States, 44122
University Hospitals
Cleveland, Ohio, United States, 44117
Contact: James Liu, MD    216-285-5028      
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
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Responsible Party: Gretchen Collins, MD, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02377492    
Other Study ID Numbers: 043231
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs