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Completed

NCT Number: NCT01700478

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

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.

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of the West Indies

Kingston, Jamaica

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Misoprostol + vasopressin

Drug

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

Other names: Cytotec

Vasopressin

Drug

Vasopressin was used in all patients during surgery.

Other names: Anti-diuretic hormone

Primary outcomes

  1. Blood loss in millilitres

    Time frame: At the time of surgery

Secondary outcomes

  1. A change in hemoglobin grams per decilitre

    Time frame: At baseline and 24hours after surgery

Sponsors and collaborators

Lead sponsor

University Hospital of the West Indies

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Oct 4, 2012
Registry last updated
Feb 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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