Myoma;UterusPhase 3NCT06325501
Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy
A Phase 3 study testing Misoprostol 200mcg Tab and Oxytocin in people with Myoma;Uterus, run by Cairo University at 1 site in Egypt.
Trial summary
Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Read more about this study
- Who is it for?
- Ages 20 to 48 years, women only
- Conditions the study is for
- Myoma;Uterus
- What is being tested?
- Misoprostol 200mcg Tab and Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Jan 2025
- 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 20 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- History of previous myomectomy
- Allergy to Misoprostol, carbetocin, TXA, ethamsylate, Oxytocin, vasopressin, bupivacaine and epinephrine.
- Hypertension.
- Cardiac and Pulmonary diseases.
- Patients who have bleeding disorders.
- Patients on antiplatelets or anticoagulant before surgery.
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- Anemia (Hb < 10g %).
- Chronic endocrine or metabolic diseases such as Diabetes.
- Renal and hepatic impairment.
- Moderate and morbid Obesity (body mass index > 35 kg/m2).
- Cases that will require intraoperative conversion of myomectomy to hysterectomy.
- Intracavitary, submucosal, pedunculated Subserosal and adnexal Myoma FIGO staging 0,1,2,7,8.
- history of Gynecological infections (PID), history of abdominal infections e.g.: peritonitis, history of any abdominal or pelvic operation for non-obstetric cause.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of medicine, Kasr el ainy hospital, Cairo university
Cairo, 11562
Mohammad A Taymour, MD, 01555761995, Mohammadtaymour@gmail.com
Waleed M Elkhyat, 01005135542, Waleed_elkhyat@yahoo.com
About this study
Official title: The Efficacy Of Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy
Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion.
Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps.
Read more
Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia.
Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy.
- Conditions
- Myoma;Uterus
- Being tested
- Misoprostol 200mcg Tab, Oxytocin
- Keywords
- misoprostol, oxytocin, myomectomy, blood loss
- Medical subject headings
- Myofibroma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 200mcg TabDrug
Also called Misotac
receiving a preoperative rectal dose of 800 ug of misoprostol half an hour before surgery
OxytocinDrug
Also called syntocinone
after the induction of general anaesthesia (GA), an infusion of 40 IU oxytocin in 500 ml normal saline was started at the rate of 250 ml/hour
| Study group | Role | What they receive |
|---|---|---|
| misoprostol | Active comparator | receiving a preoperative rectal dose of 800 ug of misoprostol half an hour before surgery Receives: Drug: Misoprostol 200mcg Tab |
| oxytocin | Active comparator | After the induction of general anaesthesia (GA), an infusion of 40 IU oxytocin in 500 ml normal saline was started at the rate of 250 ml/hour Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-operative blood loss
which was measured at the end of surgery by calculating the sum of blood in the suction bottle and the blood absorbed in the sponges. Dry sponges were weighed before the surgery and the blood-soaked sponges were weighed at the end of the surgery
Measured: time of surgery
Secondary outcomes (3)
blood transfusion
Measured: 24 hours
post-operative Hb
Measured: 24 hours
total surgery time
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Mar 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (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.
- More trials run by Cairo UniversityThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed nagy shaker ramadan, Cairo University
- Investigators
- Tarek N Anees, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325501
- Sponsor's protocol ID
- AA-2024-1
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Of Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy
- ClinicalTrials.gov ID
- NCT06325501
- Acronym / sponsor ID
- AA-2024-1
- Conditions
- Myoma;Uterus
- Keywords
- misoprostol, oxytocin, myomectomy, blood loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 22 Mar 2024 (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.
Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion.
Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps.
Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia.
Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| misoprostol | Active comparator | Drug: Misoprostol 200mcg Tabreceiving a preoperative rectal dose of 800 ug of misoprostol half an hour before surgery |
| oxytocin | Active comparator | Drug: OxytocinAfter the induction of general anaesthesia (GA), an infusion of 40 IU oxytocin in 500 ml normal saline was started at the rate of 250 ml/hour |
Who may qualify
- Ages
- 20 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- History of previous myomectomy
- Allergy to Misoprostol, carbetocin, TXA, ethamsylate, Oxytocin, vasopressin, bupivacaine and epinephrine.
- 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 |
|---|---|---|
| Misoprostol 200mcg TabAlso: Misotacreceiving a preoperative rectal dose of 800 ug of misoprostol half an hour before surgery | Drug | misoprostol |
| OxytocinAlso: syntocinoneafter the induction of general anaesthesia (GA), an infusion of 40 IU oxytocin in 500 ml normal saline was started at the rate of 250 ml/hour | Drug | oxytocin |
Primary outcome
intra-operative blood loss
Time frame: time of surgery
which was measured at the end of surgery by calculating the sum of blood in the suction bottle and the blood absorbed in the sponges. Dry sponges were weighed before the surgery and the blood-soaked sponges were weighed at the end of the surgery
3 secondary outcomes
blood transfusion
Time frame: 24 hours
post-operative Hb
Time frame: 24 hours
total surgery time
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Life Study: Lifestyle Intervention in Fibroid Elimination
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Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
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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.
Tarek N Anees, MD principal investigator
Cairo University
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 200mcg Tab and Oxytocin in people with Myoma;Uterus, run by Cairo University 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 0 inclusion and 14 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 22 Mar 2024. 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. 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 waleed M El-khayat, MD (01005263580 ext. +2, waleed_elkhyat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra-operative blood loss (time frame: time of surgery). 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 22 Mar 2024.