ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01700478
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):
Dr Sharifa Frederick, University Hospital of the West Indies

Brief Summary:
This study was done to determine if the use of a combination of preoperative rectal misoprostol 400µg used with intraoperative perivascular vasopressin is better than perivascular vasopressin used alone to decrease bleeding at myomectomy.

Condition or disease Intervention/treatment Phase
Hemorrhage Drug: Misoprostol + vasopressin Drug: Vasopressin Phase 4

Detailed Description:
A myomectomy is a fertility sparing procedure in which fibroids are removed from the uterus. This procedure can be associated with significant blood loss which can result in significant morbidity and mortality. The drug misoprostol which has been been use in the treatment of postpartum hemorrhage was given to subset of patients who were scheduled to undergo elective myomectomy at the University hospital of the West Indies and from the private practice of the participating doctors who were invited to participate in the study. Patients were randomized to receive or not to receive pre-operative rectal misoprostol 400µg, 60 minutes before surgery. Twenty five patients received misoprostol and twenty patients did not.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy
Study Start Date : February 2005
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Misoprostol + vasopressin, Vasopressin
Misoprostol 400ug given rectally one hour before surgery.
Drug: Misoprostol + vasopressin
400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery.
Other Name: Cytotec
Drug: Vasopressin
Vasopressin was used in all patients during surgery.
Other Name: Anti-diuretic hormone



Primary Outcome Measures :
  1. Blood loss in millilitres [ Time Frame: At the time of surgery ]

Secondary Outcome Measures :
  1. A change in hemoglobin grams per decilitre [ Time Frame: At baseline and 24hours after surgery ]


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.


Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with symptomatic fibroids who desire future fertility and or who wish to maintain their uterus.

Exclusion Criteria:

  • patients who have had previous myomectomy or previous pelvic surgery.
  • patients who are severely anemic or who have significant medical conditions such as cardiac or pulmonary disease.
  • patients who refuse to participate or give consent to the procedures. Patients with a known allergy to any of the study drugs.

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): NCT01700478


Locations
Jamaica
University Hospital of the West Indies
Kingston, Jamaica
Sponsors and Collaborators
University Hospital of the West Indies
Investigators
Principal Investigator: Sharifa K Frederick, dM University Hospital of the West Indies

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Sharifa Frederick, Doctor, University Hospital of the West Indies
ClinicalTrials.gov Identifier: NCT01700478     History of Changes
Other Study ID Numbers: MV-001
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: October 2012

Keywords provided by Dr Sharifa Frederick, University Hospital of the West Indies:
Myomectomy

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Misoprostol
Vasopressins
Arginine Vasopressin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents