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

A Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01700478

Enrollment

Registered

2012-10-04

Start date

2005-02-28

Completion date

2005-04-30

Last updated

2013-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage

Keywords

Myomectomy

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.

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.

Interventions

DRUGMisoprostol + vasopressin

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

DRUGVasopressin

Vasopressin was used in all patients during surgery.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Blood loss in millilitres	At the time of surgery

Secondary

Measure	Time frame
A change in hemoglobin grams per decilitre	At baseline and 24hours after surgery

Countries

Jamaica

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026