MyomaNCT05170230
The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations
A study testing Terlipressin in people with Myoma, run by Wael Elbanna Clinic at 1 site in Egypt.
Trial summary
Our study aims to evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin injection on hemoglobin level in women undergoing abdominal laparoscopic myomectomy. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Myoma
- What is being tested?
- Terlipressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Feb 2022to 30 Jun 2026
- 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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women aged 16-45 years
- Appropriate medical status for laparoscopic surgery (largest myoma ≤15 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
- 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.
Egypt1 site, 1 recruiting
- Recruiting
Wael El Banna Clinic
Maadi
Wael Elbanna, 01227760402, waelelbanna@drwaelelbanna.com
esraa moghawry, 01212421260, esraamoghawry@gmail.com
About this study
Official title: The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations: Double Blinded Randomized Placebo-Controlled Trial
Our study aims to evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin injection on hemoglobin level in women undergoing abdominal laparoscopic myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.
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 injection of Terlipressin in women undergoing laparoscopic myomectomy procedure
- Arm 2: intramyometrial injection of Carbetocin in women undergoing laparoscopic myomectomy procedure
- Arm 3: intramyometrial injection of saline in women undergoing laparoscopic myomectomy procedure 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 computer-generated randomization table with a 1:1:1 group allocation.
- Conditions
- Myoma
- Being tested
- Terlipressin
- 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 carbitocin
intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy
| Study group | Role | What they receive |
|---|---|---|
| intracapsular myomectomy Terlipressin injection | Active comparator | intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure Receives: Drug: Terlipressin |
| intracapsular myomectomy Carbetocin injection | Active comparator | intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure Receives: Drug: Terlipressin |
| intramyometrial saline | Placebo comparator | intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure Receives: Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy
measure the amount of blood loss in mm after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy
Measured: 12 hours
Secondary outcomes (2)
1. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on hemoglobin
compare the hemoglobin level before and after operation after intracapsular injection of Terlipressin versus Carbetocin saline as aplacebo in women undergoing laparoscopic myomectomy
Measured: 24 hours
2. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on operative time
- To measure the operative time in minutes after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start27 Feb 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 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 materials that will be used will include blood tests and ultrasound. The study will involve three study arms: * Arm 1: intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure * Arm 2: intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure * Arm 3: intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure 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 computer-generated randomization table with a 1:1:1 group allocation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 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
- NCT05170230
- Sponsor's protocol ID
- Elbanna_006
- Status last verified
- Oct 2023
- First submitted
- 6 Dec 2021
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marsh EE, Ekpo GE, Cardozo ER, Brocks M, Dune T, Cohen LS. Racial differences in fibroid prevalence and ultrasound findings in asymptomatic young women (18-30 years old): a pilot study. Fertil Steril. 2013 Jun;99(7):1951-7. doi: 10.1016/j.fertnstert.2013.02.017. Epub 2013 Mar 15.
PubMed 23498888Srivastava S, Mahey R, Kachhawa G, Bhatla N, Upadhyay AD, Kriplani A. Comparison of intramyometrial vasopressin plus rectal misoprostol with intramyometrial vasopressin alone to decrease blood loss during laparoscopic myomectomy: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:279-283. doi: 10.1016/j.ejogrb.2018.07.006. Epub 2018 Jul 5.
PubMed 30056355
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations: Double Blinded Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05170230
- Acronym / sponsor ID
- Elbanna_006
- Conditions
- Myoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Wael Elbanna ClinicUniversity, hospital or other
- Study start
- 27 Feb 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Dec 2021 (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.
Our study aims to evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin injection on hemoglobin level in women undergoing abdominal laparoscopic myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.
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 injection of Terlipressin in women undergoing laparoscopic myomectomy procedure
- Arm 2: intramyometrial injection of Carbetocin in women undergoing laparoscopic myomectomy procedure
- Arm 3: intramyometrial injection of saline in women undergoing laparoscopic myomectomy procedure 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 computer-generated 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
- 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 materials that will be used will include blood tests and ultrasound. The study will involve three study arms: * Arm 1: intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure * Arm 2: intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure * Arm 3: intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure 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 computer-generated randomization table with a 1:1:1 group allocation.
| Arm | Type | Receives |
|---|---|---|
| intracapsular myomectomy Terlipressin injection | Active comparator | Drug: Terlipressinintracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure |
| intracapsular myomectomy Carbetocin injection | Active comparator | Drug: Terlipressinintracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure |
| intramyometrial saline | Placebo comparator | Drug: Terlipressinintracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Women aged 16-45 years
- Appropriate medical status for laparoscopic surgery (largest myoma ≤15 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
Key exclusion criteria (7 listed)
- Previous myomectomy
- History of bleeding disorders
- Concurrent anticoagulation therapy
- History of Uncontrolled ischaemic heart disease
- Any pelvic abnormalities requiring concomitant surgery
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: carbitocinintracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy | Drug | intracapsular myomectomy Carbetocin injection, intracapsular myomectomy Terlipressin injection, intramyometrial saline |
Primary outcome
intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy
Time frame: 12 hours
measure the amount of blood loss in mm after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy
2 secondary outcomes
1. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on hemoglobin
Time frame: 24 hours
2. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on operative time
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Background: PubMed 23498888Marsh EE, Ekpo GE, Cardozo ER, Brocks M, Dune T, Cohen LS. Racial differences in fibroid prevalence and ultrasound findings in asymptomatic young women (18-30 years old): a pilot study. Fertil Steril. 2013 Jun;99(7):1951-7. doi: 10.1016/j.fertnstert.2013.02.017. Epub 2013 Mar 15.
- Background: PubMed 30056355Srivastava S, Mahey R, Kachhawa G, Bhatla N, Upadhyay AD, Kriplani A. Comparison of intramyometrial vasopressin plus rectal misoprostol with intramyometrial vasopressin alone to decrease blood loss during laparoscopic myomectomy: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:279-283. doi: 10.1016/j.ejogrb.2018.07.006. Epub 2018 Jul 5.
- 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. This study is not recruiting at the moment.
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 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 6 inclusion and 7 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 25 Jun 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. 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?
Results are not available in the source record.
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?
intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy (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 NCT05170230, which also lists 2 linked publications.
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 25 Jun 2024.