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

NCT01700478 | Completed Phase 4

• 1 other identifier: MV-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage

Keywords

Myomectomy

Outcome Measures

Primary Outcomes (1)

• Blood loss in millilitres

  At the time of surgery

Secondary Outcomes (1)

• A change in hemoglobin grams per decilitre

  At baseline and 24hours after surgery

Study Arms (1)

Misoprostol + vasopressin, Vasopressin

EXPERIMENTAL

Misoprostol 400ug given rectally one hour before surgery.

Drug: Misoprostol + vasopressin; Drug: Vasopressin

Interventions

Misoprostol + vasopressin DRUG

400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery.

Also known as: Cytotec

Misoprostol + vasopressin, Vasopressin

Vasopressin DRUG

Vasopressin was used in all patients during surgery.

Also known as: Anti-diuretic hormone

Misoprostol + vasopressin, Vasopressin

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of the West Indies: lead

Study Sites (1)

University Hospital of the West Indies

Kingston, Jamaica

Location

Related Publications (1)

• 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.

  PMID: 23876539 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Misoprostol; Vasopressins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Sharifa K Frederick, dM

  University Hospital of the West Indies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: October 4, 2012
• Study Start: February 1, 2005
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: February 11, 2013

Record last verified: 2012-10

Locations

JA (1)