Preoperative Misoprostol in Reducing Blood Loss in Total Abdominal Hysterectomy (TAH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199159
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : September 10, 2010
Information provided by:
The University of Hong Kong

Brief Summary:
Total abdominal hysterectomy is known to be associated with operative blood loss, which can lead to patients' morbidity. Misoprostol, a prostaglandin, has been shown to be effective in reducing operative blood loss during myomectomy. It is the first study to investigate if preoperative misoprostol is effective in reducing operative blood loss during total abdominal hysterectomy.

Condition or disease Intervention/treatment Phase
Hysterectomy Drug: Misoprostol Drug: Vitamin B 6 Not Applicable

Detailed Description:

Uterine leiomyoma is the commonest benign tumour affecting women in their reproductive age. Around 20-50% can cause symptoms that warrant treatment. Different medical therapies, including gonadotrophin releasing hormone analogues, mifepristone, progestins and androgens have been tried. However, most of the medical therapy have significant side-effects that would only allow a short-term treatment. Total abdominal hysterectomy is the definitive treatment for large, symptomatic fibroids. Operative mortality of total abdominal hysterectomy is rare. However, the operation may be associated with significant morbidities. Significant operative blood loss that required blood transfusion and oral iron supplement is not uncommonly encountered after total abdominal hysterectomy.

Various methods have been tried to reduce the operative blood loss during total abdominal hysterectomy. A course of hormonal therapy for a few months before operation aiming to shrink the size of fibroid(s) and reduce the vascularity is the commonest approach. Although it is effective, there are significant side effects and the cost of gonadotrophin releasing hormone analogues is high. Intramyometrial vasopressin injection has been reported, but serious complications have been reported.

Misoprostol, a prostaglandin E1 analogue, has been widely used in clinical practice in obstetrics and gynaecology. It stimulates uterine contractions and this increase in myometrial contraction will lead to contraction of the vessels supplying blood to the leiomyomas. Misoprostol has also been shown to increase the uterine artery resistance and reduce the blood flow to the leiomyomas. Study by Celik et al has shown that pre-operative misoprostol can reduce intra-operative blood loss and need for post-operative blood transfusion after abdominal myomectomy. Chang et al investigated the use of misoprostol and oxytocin in laparoscopy-assisted vaginal hysterectomy and found that the combination of pre-operative misoprostol and intra-operative oxytocin can reduce blood loss by 200 ml. As misoprostol can stimulate uterine contraction and reduce uterine blood flow, based on the hypothesis that pre-operative misoprostol may redistribute the blood from the diseased uterus back to the circulation hence reducing operative blood loss during total abdominal hysterectomy, we use a double-blind randomized controlled trial to investigate whether a single dose of sublingual misoprostol before total abdominal hysterectomy +/- salpingo-oophorectomy for symptomatic uterine leiomyomas can reduce operative blood loss and need for post-operative blood transfusion.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Preoperative Misoprostol in Reducing Operative Blood Loss During Hysterectomy
Study Start Date : January 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: preoperative misoprostol
400mcg misoprostol given preoperatively
Drug: Misoprostol
400mcg misoprostol given sublingually 30 minutes before total abdominal hysterectomy
Placebo Comparator: Placebo Drug: Vitamin B 6
20mg vitamin B6 given sublingually 30 minutes before total abdominal hysterectomy

Primary Outcome Measures :
  1. operative blood loss [ Time Frame: duration of operation, up to 3 hours ]
    The total volume of blood loss was estimated by measuring the amount of blood accumulated in the aspiration equipment and the amount of blood on the surgical gauze using a alkaline haematin method.

Secondary Outcome Measures :
  1. the requirement of blood transfusion [ Time Frame: from intra-operation to hospital discharge, up to 7 days ]
  2. the change in haemoglobin level after operation [ Time Frame: preoperative to 30 hours postoperative ]
  3. the incidence of side effects [ Time Frame: 30 minutes after misoprostol/placebo was given ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • symptomatic women undergoing total abdominal hysterectomy for various benign gynaecological diseases in Queen Mary Hospital

Exclusion Criteria:

  • any contraindication to misoprostol, including mitral stenosis, glaucoma, sickle cell anaemia, diastolic pressure over 100mmHg, severe asthma, or known allergy to prostaglandin;
  • a known history of pelvic/ovarian endometriosis;
  • a known history of or active medical disease;
  • a known history of previous myomectomy;
  • women who had pre-operative mifepristone or gonadotrophin releasing hormone analogues treatment;
  • women with mental impairment or incompetent in giving consent.

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 identifier (NCT number): NCT01199159

Hong Kong
University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Joyce Chai, University of Hong Kong Identifier: NCT01199159     History of Changes
Other Study ID Numbers: misohys001
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: September 10, 2010
Last Verified: September 2010

Keywords provided by The University of Hong Kong:
operative blood loss
total abdominal hysterectomy

Additional relevant MeSH terms:
Pathologic Processes
Vitamin B 6
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Anti-Ulcer Agents
Gastrointestinal Agents