MyomamyomectomyNCT05266534
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets
A study testing Terlipressin, Carbetocin and Saline in people with Myoma, run by Wael Elbanna Clinic at 1 site in Egypt.
Trial summary
For gynecologists, reaching a conclusion about the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy that would influence the clinical decision and best practice. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- Myoma
- What is being tested?
- Terlipressin, Carbetocin and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women aged 16-45 yearsAppropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm)
- Baseline hemoglobin ≥9 g/dl
- No contra-indications to the use of glyopressin or carbitocin
- Myoma-related symptoms, such as pelvic pressure or pain,menorrhagia, or infertility
- Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks)
Who cannot join
- Open myomectomy using mechanical tourniquet
- Previous myomectomy
- History of bleeding disorders
- Concurrent anticoagulation therapy
- History of Uncontrolled ischaemic heart disease
- Any pelvic abnormalities requiring concomitant surgery
- Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
- Inability to understand and provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Wael El Banna Clinic
Maadi
Wael Elbanna, consultant, 01227760402, waelelbanna@drwaelelbanna.com
esraa moghawry, specialist, 01212421260
About this study
Official title: The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets.
For gynecologists, reaching a conclusion about the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy that would influence the clinical decision and best practice. Besides enriching the clinical evidence in open myomectomy without using haemostatic tourniquets. For society, our conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for women undergoing open myomectomy without using haemostatic tourniquets.
Read the detailed description
This study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at Wael ElBanna Clinic and the NRC site. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. Data will be pooled and presented in aggregate, without the identification of individual subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:
- Arm 1: intramyometrial Terlipressin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets
- Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets
- Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure without using haemostatic tourniquets Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. Women will be randomized to one of the three arms using a computergenerated randomization table with a 1:1:1 group allocation
- Conditions
- Myoma
- Being tested
- Terlipressin, Carbetocin, Saline
- Medical subject headings
- Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Also called glypressin
the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
CarbetocinDrug
Also called pabal
the efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
SalineDrug
Also called NaCl 0.9
the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
| Study group | Role | What they receive |
|---|---|---|
| intramyometrial Terlipressin injection in women undergoing open myomectomy | Active comparator | intramyometrial Terlipressin injection Receives: Drug: Terlipressin |
| intramyometrial Carbetocin injection in women undergoing open myomectomy | Active comparator | intramyometrial Carbetocin injection Receives: Drug: Carbetocin |
| intramyometrial saline injection in women undergoing open myomectomy procedure | Placebo comparator | intramyometrial saline injection in women Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets
the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets
Measured: 12 hours
Secondary outcomes (3)
To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets
To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets
Measured: 24 hours
To measure the operative time in each group without using haemostatic tourniquets
To measure the operative time in each group without using haemostatic tourniquets
Measured: 24 hours
to assess the measure the severity of pain using VAS score
post operative pain VAS score
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 posted4 Mar 2022
- Study start30 Dec 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2026 (estimated)
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 MyomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blinded Randomized Placebo-Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wael Elbanna Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266534
- Sponsor's protocol ID
- Elbanna_008
- Acronym
- myomectomy
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parker WH, Berek JS, Pritts EA, Olive D, Chalas E, Clarke-Pearson D. Regarding "Incidence of Occult Uterine Malignancy Following Vaginal Hysterectomy with Morcellation". J Minim Invasive Gynecol. 2018 Jan;25(1):187-188. doi: 10.1016/j.jmig.2017.07.027. Epub 2017 Aug 18. No abstract available.
PubMed 28826956
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets.
- ClinicalTrials.gov ID
- NCT05266534
- Acronym / sponsor ID
- myomectomy / Elbanna_008
- Conditions
- Myoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Wael Elbanna ClinicUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Mar 2022 (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.
For gynecologists, reaching a conclusion about the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy that would influence the clinical decision and best practice. Besides enriching the clinical evidence in open myomectomy without using haemostatic tourniquets. For society, our conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for women undergoing open myomectomy without using haemostatic tourniquets.
Detailed description
This study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at Wael ElBanna Clinic and the NRC site. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. Data will be pooled and presented in aggregate, without the identification of individual subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:
- Arm 1: intramyometrial Terlipressin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets
- Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets
- Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure without using haemostatic tourniquets Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. Women will be randomized to one of the three arms using a computergenerated randomization table with a 1:1:1 group allocation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Double Blinded Randomized Placebo-Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| intramyometrial Terlipressin injection in women undergoing open myomectomy | Active comparator | Drug: Terlipressinintramyometrial Terlipressin injection |
| intramyometrial Carbetocin injection in women undergoing open myomectomy | Active comparator | Drug: Carbetocinintramyometrial Carbetocin injection |
| intramyometrial saline injection in women undergoing open myomectomy procedure | Placebo comparator | Drug: Salineintramyometrial saline injection in women |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Women aged 16-45 yearsAppropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm)
- Baseline hemoglobin ≥9 g/dl
- No contra-indications to the use of glyopressin or carbitocin
- Myoma-related symptoms, such as pelvic pressure or pain,menorrhagia, or infertility
- Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks)
Key exclusion criteria (8 listed)
- Open myomectomy using mechanical tourniquet
- Previous myomectomy
- History of bleeding disorders
- Concurrent anticoagulation therapy
- History of Uncontrolled ischaemic heart disease
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 |
|---|---|---|
| TerlipressinAlso: glypressinthe efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy | Drug | intramyometrial Terlipressin injection in women undergoing open myomectomy |
| CarbetocinAlso: pabalthe efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy | Drug | intramyometrial Carbetocin injection in women undergoing open myomectomy |
| SalineAlso: NaCl 0.9the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy | Drug | intramyometrial saline injection in women undergoing open myomectomy procedure |
Primary outcome
To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets
Time frame: 12 hours
the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets
3 secondary outcomes
To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets
Time frame: 24 hours
To measure the operative time in each group without using haemostatic tourniquets
Time frame: 24 hours
to assess the measure the severity of pain using VAS score
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 28826956Parker WH, Berek JS, Pritts EA, Olive D, Chalas E, Clarke-Pearson D. Regarding "Incidence of Occult Uterine Malignancy Following Vaginal Hysterectomy with Morcellation". J Minim Invasive Gynecol. 2018 Jan;25(1):187-188. doi: 10.1016/j.jmig.2017.07.027. Epub 2017 Aug 18. No abstract available.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terlipressin, Carbetocin and Saline in people with Myoma, run by Wael Elbanna Clinic 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 8 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: looking for participants now, as of the sponsor's last update on 4 Mar 2022. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wael El Banna (01227760402, waelelbanna@drwaelelbanna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets (time frame: 12 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 NCT05266534, 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 4 Mar 2022.