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

NCT ID: NCT01199159

Last Updated: 2010-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-04-30

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.

Conditions

Hysterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

preoperative misoprostol

400mcg misoprostol given preoperatively

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

400mcg misoprostol given sublingually 30 minutes before total abdominal hysterectomy

Placebo

Group Type: PLACEBO_COMPARATOR

Vitamin B 6

Intervention Type: DRUG

20mg vitamin B6 given sublingually 30 minutes before total abdominal hysterectomy

Interventions

Misoprostol

400mcg misoprostol given sublingually 30 minutes before total abdominal hysterectomy

Intervention Type: DRUG

Vitamin B 6

20mg vitamin B6 given sublingually 30 minutes before total abdominal hysterectomy

Intervention Type: DRUG

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

University of Hong Kong

Locations

University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 21514988 (View on PubMed)

Other Identifiers

misohys001

Identifier Type: -

Identifier Source: org_study_id