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

NCT01199159 | Completed

• 1 other identifier: misohys001
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Hysterectomy

Keywords

misoprostol; hysterectomy; operative blood loss; total abdominal hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  duration of operation, up to 3 hours

Secondary Outcomes (3)

• the requirement of blood transfusion

  from intra-operation to hospital discharge, up to 7 days

• the change in haemoglobin level after operation

  preoperative to 30 hours postoperative

• the incidence of side effects

  30 minutes after misoprostol/placebo was given

Study Arms (2)

preoperative misoprostol

ACTIVE COMPARATOR

400mcg misoprostol given preoperatively

Drug: Misoprostol

Placebo

PLACEBO COMPARATOR

Drug: Vitamin B 6

Interventions

Misoprostol DRUG

400mcg misoprostol given sublingually 30 minutes before total abdominal hysterectomy

preoperative misoprostol

Vitamin B 6 DRUG

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

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 21514988 DERIVED

MeSH Terms

Interventions

Misoprostol; Vitamin B 6

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2010
• First Posted: September 10, 2010
• Study Start: January 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 10, 2010

Record last verified: 2010-09

Locations

HK (1)