HysterectomyNCT01199159
Preoperative Misoprostol in Reducing Blood Loss in Total Abdominal Hysterectomy (TAH)
A study testing Misoprostol and Vitamin B 6 in people with Hysterectomy, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Misoprostol and Vitamin B 6
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2007to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- symptomatic women undergoing total abdominal hysterectomy for various benign gynaecological diseases in Queen Mary Hospital
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the Preoperative Misoprostol in Reducing Operative Blood Loss During Hysterectomy
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.
Read the 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
- Being tested
- Misoprostol, Vitamin B 6
- Keywords
- misoprostol, hysterectomy, operative blood loss, total abdominal hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
400mcg misoprostol given sublingually 30 minutes before total abdominal hysterectomy
Vitamin B 6Drug
20mg vitamin B6 given sublingually 30 minutes before total abdominal hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| preoperative misoprostol | Active comparator | 400mcg misoprostol given preoperatively Receives: Drug: Misoprostol |
| Placebo | Placebo comparator | Not described Receives: Drug: Vitamin B 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: duration of operation, up to 3 hours
Secondary outcomes (3)
the requirement of blood transfusion
Measured: from intra-operation to hospital discharge, up to 7 days
the change in haemoglobin level after operation
Measured: preoperative to 30 hours postoperative
the incidence of side effects
Measured: 30 minutes after misoprostol/placebo was given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startJan 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199159
- Sponsor's protocol ID
- misohys001
- Status last verified
- Sep 2010
- First submitted
- 6 Sep 2010
- Last updated
- 10 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21514988
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Preoperative Misoprostol in Reducing Operative Blood Loss During Hysterectomy
- ClinicalTrials.gov ID
- NCT01199159
- Acronym / sponsor ID
- misohys001
- Conditions
- Hysterectomy
- Keywords
- misoprostol, hysterectomy, operative blood loss, total abdominal hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative misoprostol | Active comparator | Drug: Misoprostol400mcg misoprostol given preoperatively |
| Placebo | Placebo comparator | Drug: Vitamin B 6 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- symptomatic women undergoing total abdominal hysterectomy for various benign gynaecological diseases in Queen Mary Hospital
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol400mcg misoprostol given sublingually 30 minutes before total abdominal hysterectomy | Drug | preoperative misoprostol |
| Vitamin B 620mg vitamin B6 given sublingually 30 minutes before total abdominal hysterectomy | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
the requirement of blood transfusion
Time frame: from intra-operation to hospital discharge, up to 7 days
the change in haemoglobin level after operation
Time frame: preoperative to 30 hours postoperative
the incidence of side effects
Time frame: 30 minutes after misoprostol/placebo was given
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2010.
- Derived from this study: PubMed 21514988Chai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol and Vitamin B 6 in people with Hysterectomy, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative blood loss (time frame: duration of operation, up to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01199159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2010.