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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Sharifa Frederick, University Hospital of the West Indies
ClinicalTrials.gov Identifier:
NCT01700478
First received: September 25, 2012
Last updated: February 7, 2013
Last verified: October 2012
  Purpose

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 Intervention Phase
Hemorrhage
Drug: Misoprostol + vasopressin
Drug: Vasopressin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by University Hospital of the West Indies:

Primary Outcome Measures:
  • Blood loss in millilitres [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A change in hemoglobin grams per decilitre [ Time Frame: At baseline and 24hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2005
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 40 Years
Genders 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University Hospital of the West Indies

Additional 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
Study First Received: September 25, 2012
Last Updated: February 7, 2013
Health Authority: Jamaica: Ministry of Health

Keywords provided by University Hospital of the West Indies:
Myomectomy

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

ClinicalTrials.gov processed this record on August 20, 2014