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

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01199159
First received: September 6, 2010
Last updated: September 9, 2010
Last verified: September 2010
  Purpose

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 Intervention
Hysterectomy
Drug: Misoprostol
Drug: Vitamin B 6

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Preoperative Misoprostol in Reducing Operative Blood Loss During Hysterectomy

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • operative blood loss [ Time Frame: duration of operation, up to 3 hours ] [ Designated as safety issue: No ]
    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:
  • the requirement of blood transfusion [ Time Frame: from intra-operation to hospital discharge, up to 7 days ] [ Designated as safety issue: No ]
  • the change in haemoglobin level after operation [ Time Frame: preoperative to 30 hours postoperative ] [ Designated as safety issue: No ]
  • the incidence of side effects [ Time Frame: 30 minutes after misoprostol/placebo was given ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01199159

Locations
Hong Kong
University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
  More Information

No publications provided by The University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joyce Chai, University of Hong Kong
ClinicalTrials.gov Identifier: NCT01199159     History of Changes
Other Study ID Numbers: misohys001
Study First Received: September 6, 2010
Last Updated: September 9, 2010
Health Authority: Hong Kong: Ethics Committee

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Vitamins
Vitamin B 6
Pyridoxine
Pyridoxal
Misoprostol
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on September 16, 2014