search
Back to results

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

Primary Purpose

Hysterectomy

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Misoprostol
Vitamin B 6
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hysterectomy focused on measuring misoprostol, hysterectomy, operative blood loss, total abdominal hysterectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

preoperative misoprostol

Placebo

Arm Description

400mcg misoprostol given preoperatively

Outcomes

Primary Outcome Measures

operative blood loss
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
the change in haemoglobin level after operation
the incidence of side effects

Full Information

First Posted
September 6, 2010
Last Updated
September 9, 2010
Sponsor
The University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT01199159
Brief Title
Preoperative Misoprostol in Reducing Blood Loss in Total Abdominal Hysterectomy (TAH)
Official Title
A Pilot Study of the Preoperative Misoprostol in Reducing Operative Blood Loss During Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysterectomy
Keywords
misoprostol, hysterectomy, operative blood loss, total abdominal hysterectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
preoperative misoprostol
Arm Type
Active Comparator
Arm Description
400mcg misoprostol given preoperatively
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
400mcg misoprostol given sublingually 30 minutes before total abdominal hysterectomy
Intervention Type
Drug
Intervention Name(s)
Vitamin B 6
Intervention Description
20mg vitamin B6 given sublingually 30 minutes before total abdominal hysterectomy
Primary Outcome Measure Information:
Title
operative blood loss
Description
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.
Time Frame
duration of operation, up to 3 hours
Secondary Outcome Measure Information:
Title
the requirement of blood transfusion
Time Frame
from intra-operation to hospital discharge, up to 7 days
Title
the change in haemoglobin level after operation
Time Frame
preoperative to 30 hours postoperative
Title
the incidence of side effects
Time Frame
30 minutes after misoprostol/placebo was given

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
21514988
Citation
Chai J, Hon E, Li CF, Pun TC, Yeung SB, Ho PC. A pilot study of pre-operative misoprostol in reducing operative blood loss during hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2011 Sep;158(1):72-5. doi: 10.1016/j.ejogrb.2011.03.023. Epub 2011 Apr 23.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs