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

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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

Study Description

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	45 participants
Allocation:	N/A
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

MedlinePlus related topics: Bleeding Uterine Fibroids

Drug Information available for: Argipressin Vasopressin Misoprostol

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Blood loss in millilitres [ Time Frame: At the time of surgery ]

Secondary Outcome Measures :

A change in hemoglobin grams per decilitre [ Time Frame: At baseline and 24hours after surgery ]

Eligibility Criteria

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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.

Contacts and Locations

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

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Jamaica
University Hospital of the West Indies
Kingston, Jamaica

Sponsors and Collaborators

University Hospital of the West Indies

Investigators

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Principal Investigator:	Sharifa K Frederick, dM	University Hospital of the West Indies

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Frederick S, Frederick J, Fletcher H, Reid M, Hardie M, Gardner W. A trial comparing the use of rectal misoprostol plus perivascular vasopressin with perivascular vasopressin alone to decrease myometrial bleeding at the time of abdominal myomectomy. Fertil Steril. 2013 Oct;100(4):1044-9. doi: 10.1016/j.fertnstert.2013.06.022. Epub 2013 Jul 19.

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Responsible Party:	Dr Sharifa Frederick, Doctor, University Hospital of the West Indies
ClinicalTrials.gov Identifier:	NCT01700478
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:

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

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