Myoma;UterusPhase 3NCT03483142
the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation
A Phase 3 study testing Misoprostol in people with Myoma;Uterus and Blood Loss, run by ahmed nagy shaker ramadan at 1 site in Egypt.
Trial summary
assess the effect of using misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications. Research question Does pre-operative misoprostol affect on intra-operative blood loss during and after myomectomy operation ?. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Myoma;Uterus, Blood Loss
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 30 Jul 2018
- Phase
- Phase 3
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal patients aged between 35 to 50 years old.
- Five or less symptomatic uterine myomas .
- Maximum diameter of the largest myoma is 6 cm .
- All myomas are subserous or intramural.
- Uterine size less than 24 weeks pregnancy
Who cannot join
- History of previous surgery.
- Allergy to Misoprostol.
- Hypertension.
- Cardiac and Pulmonary diseases.
- Patients who have bleeding disorders.
- Anemia (Hb < 10g %).
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- Chronic endocrine or metabolic diseases such as Diabetes.
- Obesity (body mass index > 30 kg/m2).
- Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity Hospital
Cairo, Abbasia, 11566
abd el fatah soaod, professor, +226834576, Viced.research@med.asu.edu.eg
About this study
assess the effect of using misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications. Research question Does pre-operative misoprostol affect on intra-operative blood loss during and after myomectomy operation ?. Research hypothesis Pre-operative misoprostol may reduce intra-operative blood loss during and after myomectomy operation .
Read the detailed description
. Type of Study : Prospective double blind randomized placebo controlled clinical trial.
- Study Setting : This study will be conducted in Ain Shams University Maternity hospital.
- Study Period : 6 months
- Study Population : Patients will be recruited in this study those attending gynecology ward at Ain Shams University Maternity hospital who are 25-50 years old with symptomatic uterine myoma
Methodology
All women will be subjected to:
History taking:
It includes name, age, occupation, marriage and special habits,last menstrual period, menstrual history, history of present illness ( symptoms related to myoma ), any medical disorders and any previous surgeries.
Examination
General examination:
It includes blood pressure, heart rate and body temperature, body mass index, head\& neck examination Bilateral lower limb examination.
Abdominal examination:
It includes:
- Inspection : pelvi-abdominal swelling
- Palpation : smooth or irregular surface - mobility - consistency - size - tenderness
- Auscultation : soufflé ( increased vascularity )
- Percussion : dullness
Local examination:
Vaginal examnation will be done to detect uterine swelling with transmitted movement to the cervix . if movement not transmitted to cervix , it revealed extra-uterine swelling , also examination of adnexa Investigations Ultrasonography ( abdominal / vaginal ), (hysteroscopy , MRI , D\&C if indicated ) Pre-operative investigation ( Complete blood picture, blood group , RH, hematocrite , Kidney Function Test , Liver Function Test , random Blood Sugar , urine analysis Intervention
All women will be randomly assigned to either:
Group A ( study group ) ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol.
Group B (control group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
In all operations, the abdomen is entered by a Pfannenstiel incision. The operations are performed by the same team to avoid any bias related to surgical skills. The total volume of intra-operative blood loss is estimated by measuring the amount of blood accumulated in the suction container and the amount of blood on the surgical gauze by gauze weighting, the surgical gauzes are weighted before and after surgery using a scale accurate to 1 gram and the weight difference was calculated. The weight of 1 gram is taken as 1 ml blood.
Vital data during operation and the duration of the operation are recorded (time from opening of the peritoneum until its closure). The postoperative haemoglobin level is measured for each participant 24 h after the operation. Records are kept for any intra-operative or postoperative blood transfusion. Any postoperative adverse events, including any febrile episode (increase to or over 38.5°C in body temperature within 24 h following surgery) are documented. Also post operative vital data will be recorded
- Conditions
- Myoma;Uterus, Blood Loss
- Being tested
- Misoprostol, Placebos
- Medical subject headings
- Myofibroma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called misotac
( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
PlacebosDrug
( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol
| Study group | Role | What they receive |
|---|---|---|
| misoprostol group | Experimental | misoprostol group ( study group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation Receives: Drug: Misoprostol |
| placebo group | Placebo comparator | ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
reduce intra operative blood loss during myomectomy
Measured: time of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Nov 2017
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myoma;UterusStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention All women will be randomly assigned to either: Group A ( study group ) ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol. Group B (control group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ahmed nagy shaker ramadan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ahmed nagy shaker ramadan, Ain Shams Maternity Hospital
- Investigators
- sabry sayed, professor, Principal investigator, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483142
- Sponsor's protocol ID
- Myomectomy
- Status last verified
- May 2018
- First submitted
- 16 Mar 2018
- Last updated
- 18 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation
- ClinicalTrials.gov ID
- NCT03483142
- Acronym / sponsor ID
- Myomectomy
- Conditions
- Myoma;Uterus, Blood Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ahmed nagy shaker ramadanUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 30 Mar 2018 (actual)
- 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.
assess the effect of using misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications. Research question Does pre-operative misoprostol affect on intra-operative blood loss during and after myomectomy operation ?. Research hypothesis Pre-operative misoprostol may reduce intra-operative blood loss during and after myomectomy operation .
Detailed description
. Type of Study : Prospective double blind randomized placebo controlled clinical trial.
- Study Setting : This study will be conducted in Ain Shams University Maternity hospital.
- Study Period : 6 months
- Study Population : Patients will be recruited in this study those attending gynecology ward at Ain Shams University Maternity hospital who are 25-50 years old with symptomatic uterine myoma
Methodology
All women will be subjected to:
History taking:
It includes name, age, occupation, marriage and special habits,last menstrual period, menstrual history, history of present illness ( symptoms related to myoma ), any medical disorders and any previous surgeries.
Examination
General examination:
It includes blood pressure, heart rate and body temperature, body mass index, head\& neck examination Bilateral lower limb examination.
Abdominal examination:
It includes:
- Inspection : pelvi-abdominal swelling
- Palpation : smooth or irregular surface - mobility - consistency - size - tenderness
- Auscultation : soufflé ( increased vascularity )
- Percussion : dullness
Local examination:
Vaginal examnation will be done to detect uterine swelling with transmitted movement to the cervix . if movement not transmitted to cervix , it revealed extra-uterine swelling , also examination of adnexa Investigations Ultrasonography ( abdominal / vaginal ), (hysteroscopy , MRI , D\&C if indicated ) Pre-operative investigation ( Complete blood picture, blood group , RH, hematocrite , Kidney Function Test , Liver Function Test , random Blood Sugar , urine analysis Intervention
All women will be randomly assigned to either:
Group A ( study group ) ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol.
Group B (control group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
In all operations, the abdomen is entered by a Pfannenstiel incision. The operations are performed by the same team to avoid any bias related to surgical skills. The total volume of intra-operative blood loss is estimated by measuring the amount of blood accumulated in the suction container and the amount of blood on the surgical gauze by gauze weighting, the surgical gauzes are weighted before and after surgery using a scale accurate to 1 gram and the weight difference was calculated. The weight of 1 gram is taken as 1 ml blood.
Vital data during operation and the duration of the operation are recorded (time from opening of the peritoneum until its closure). The postoperative haemoglobin level is measured for each participant 24 h after the operation. Records are kept for any intra-operative or postoperative blood transfusion. Any postoperative adverse events, including any febrile episode (increase to or over 38.5°C in body temperature within 24 h following surgery) are documented. Also post operative vital data will be recorded
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention All women will be randomly assigned to either: Group A ( study group ) ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol. Group B (control group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
| Arm | Type | Receives |
|---|---|---|
| misoprostol group | Experimental | Drug: Misoprostolmisoprostol group ( study group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation |
| placebo group | Placebo comparator | Drug: Placebos( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Premenopausal patients aged between 35 to 50 years old.
- Five or less symptomatic uterine myomas .
- Maximum diameter of the largest myoma is 6 cm .
- All myomas are subserous or intramural.
- Uterine size less than 24 weeks pregnancy
Key exclusion criteria (9 listed)
- History of previous surgery.
- Allergy to Misoprostol.
- Hypertension.
- Cardiac and Pulmonary diseases.
- Patients who have bleeding disorders.
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 |
|---|---|---|
| MisoprostolAlso: misotac( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation | Drug | misoprostol group |
| Placebos( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol | Drug | placebo group |
Primary outcome
blood loss
Time frame: time of operation
reduce intra operative blood loss during myomectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
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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.
sabry sayed, professor principal investigator
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misoprostol in people with Myoma;Uterus and Blood Loss, run by ahmed nagy shaker ramadan at 1 site in Egypt.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 May 2018. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dina yahia mansour, MD (+201006575414, dinayahiamansour@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss (time frame: time of operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2018.