Myoma;UterusNCT07390864
Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy
A study testing Methylergometrine (Intramyometrial Injection) and Carbetocin (Intramyometrial Injection) in people with Myoma;Uterus, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial is to determine whether intramyometrial ergometrine injection or intramyometrial carbetocin injection is more effective in reducing blood loss during and after abdominal myomectomy in women undergoing surgery for symptomatic uterine fibroids. Read more about this study
- Who is it for?
- Ages 25 to 48 years, women only
- Conditions the study is for
- Myoma;Uterus
- What is being tested?
- Methylergometrine (Intramyometrial Injection) and Carbetocin (Intramyometrial Injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2026to 30 Aug 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 25 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 25 to 48 years
- Body mass index (BMI) < 35 kg/m²
- Symptomatic uterine fibroids requiring surgical management (e.g., abnormal uterine bleeding, pelvic pain, or pressure symptoms)
- Intramyometrial uterine myomas classified as FIGO types 3 to 6, diagnosed by transvaginal ultrasonography or magnetic resonance imaging
- Maximum diameter of the largest myoma ≤ 20 cm
- Eligible for and scheduled to undergo abdominal myomectomy
- Able and willing to provide written informed consent
Who cannot join
- FIGO type 0, 1, 2, 7, or 8 myomas (intracavitary, submucosal, pedunculated subserosal, cervical, or adnexal)
- History of pelvic inflammatory disease, peritonitis, or significant abdominal or pelvic infection
- History of prior uterine surgery
- Use of hormonal treatment within 3 months prior to enrollment
- Contraindication to methylergometrine or carbetocin, including:
- Known drug allergy
Show all 16Show fewer
- Hypertension
- Cardiac or pulmonary disease
- Chronic endocrine or metabolic disease (e.g., diabetes mellitus)
- Renal or hepatic impairment
- High risk of bleeding, including:
- Known bleeding disorders
- Current use of antiplatelet or anticoagulant therapy
- Preoperative anemia (hemoglobin < 10 g/dL)
- BMI ≥ 35 kg/m²
- Intraoperative conversion from myomectomy to hysterectomy
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
Fayoum University
Al Fayyum, Faiyum Governorate, 38521
Haitham M Badran, MD, 01000151515, haitham.badran@fayoum.edu.eg
About this study
Official title: Intramyometrial Ergometrine Injection Versus Intramyometrial Carbetocin Injection to Decrease Blood Loss During and After Abdominal Myomectomy: A Randomized Clinical Trial
The goal of this randomized clinical trial is to determine whether intramyometrial ergometrine injection or intramyometrial carbetocin injection is more effective in reducing blood loss during and after abdominal myomectomy in women undergoing surgery for symptomatic uterine fibroids.
The main questions it aims to answer are:
Read more
Does intramyometrial ergometrine reduce intraoperative and postoperative blood loss during abdominal myomectomy?
Does intramyometrial carbetocin reduce intraoperative and postoperative blood loss during abdominal myomectomy?
Is there a difference between the two drugs in the need for blood transfusion and postoperative hemoglobin drop?
Researchers will compare intramyometrial ergometrine injection with intramyometrial carbetocin injection to see which intervention is more effective in controlling surgical bleeding and improving surgical outcomes.
Participants will:
Undergo abdominal myomectomy for uterine fibroids
Receive either intramyometrial ergometrine or intramyometrial carbetocin during surgery
Be monitored for intraoperative blood loss, postoperative blood loss, hemoglobin changes, and need for blood transfusion
Read the detailed description
Uterine leiomyomas are the most common benign tumors of the female reproductive tract and frequently require surgical management when symptomatic. Abdominal myomectomy remains the standard fertility-preserving surgical option for women with large or multiple intramyometrial fibroids. However, excessive intraoperative and postoperative blood loss continues to be a major challenge during myomectomy and is associated with increased morbidity, blood transfusion requirements, prolonged hospitalization, and delayed recovery.
Several pharmacological and surgical strategies have been investigated to minimize blood loss during myomectomy, including mechanical tourniquets, vasoconstrictors, uterine artery occlusion, and uterotonic agents. Among uterotonics, methylergometrine maleate and carbetocin are well-established agents that induce sustained uterine contractions and may reduce bleeding by compressing uterine vasculature. Methylergometrine, an ergot alkaloid, has long been used in obstetric hemorrhage, while carbetocin, a long-acting oxytocin analogue, offers prolonged uterotonic activity with a favorable pharmacokinetic profile. Despite their individual use, comparative data on their intramyometrial administration during abdominal myomectomy remain limited.
This prospective, double-blind, randomized comparative clinical trial is designed to evaluate and compare the effectiveness of intramyometrial methylergometrine versus intramyometrial carbetocin in reducing blood loss during and after abdominal myomectomy. The study will be conducted at Fayoum University maternity hospitals over an anticipated period of 20 months. To minimize bias, all procedures will be performed by the same surgical team following a standardized operative technique.
Participants will be randomly allocated to one of two intervention arms. In the first arm, methylergometrine maleate diluted in saline will be injected intramyometrially around the myoma before uterine incision. In the second arm, carbetocin diluted in saline will be administered in the same intramyometrial manner. The injections will be given circumferentially around the myoma, approximately 1-2 cm from its margins, and repeated as needed according to the number of myomas. Allocation concealment will be ensured using sequentially numbered opaque sealed envelopes, and double blinding will be maintained by coding the study drugs, with the allocation key retained by a designated supervisor until study completion.
A standardized abdominal myomectomy technique will be used in all cases, including Pfannenstiel incision, careful enucleation of myomas, meticulous hemostasis, layered uterine closure, and routine use of intraperitoneal drainage. Intraoperative blood loss will be quantified using a gravimetric method combined with suction measurements, while postoperative blood loss will be assessed via drain output. Perioperative monitoring will include vital signs, laboratory investigations, and clinical assessment for adverse events.
Safety monitoring will focus on drug-related side effects, hemodynamic changes, thromboembolic manifestations, and postoperative complications. The need for intraoperative or postoperative blood transfusion will be determined according to predefined clinical and laboratory criteria. Participants will be followed postoperatively until discharge and reassessed during early follow-up to ensure recovery and detect delayed complications.
The findings of this study are expected to provide evidence-based guidance on the optimal intramyometrial uterotonic agent for reducing blood loss during abdominal myomectomy, thereby improving surgical safety and patient outcomes in gynecologic practice.
- Conditions
- Myoma;Uterus
- Being tested
- Methylergometrine (Intramyometrial Injection), Carbetocin (Intramyometrial Injection)
- Keywords
- Ergometrine, Carbetocin, Blood Loss, Abdominal Myomectomy
- Medical subject headings
- Myofibroma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylergometrine (Intramyometrial Injection)Drug
Also called Methylergometrine maleate, Ergometrine, Methergine
Methylergometrine maleate is administered as an intramyometrial injection diluted in normal saline and injected circumferentially around the myoma before uterine incision during abdominal myomectomy to induce sustained uterine contraction and reduce surgical blood loss.
Carbetocin (Intramyometrial Injection)Drug
Also called Carbetocin, Long-acting oxytocin analogue
Carbetocin is administered as an intramyometrial injection diluted in normal saline and injected circumferentially around the myoma before uterine incision during abdominal myomectomy to promote sustained uterine contraction and reduce intraoperative and postoperative blood loss.
| Study group | Role | What they receive |
|---|---|---|
| Intramyometrial Ergometrine Injection | Active comparator | Participants receive intramyometrial injection of methylergometrine maleate diluted in saline and administered circumferentially around the myoma before uterine incision during abdominal myomectomy. Receives: Drug: Methylergometrine (Intramyometrial Injection) |
| Intramyometrial Carbetocin Injection | Experimental | Participants receive intramyometrial injection of carbetocin diluted in saline and administered circumferentially around the myoma before uterine incision during abdominal myomectomy. Receives: Drug: Carbetocin (Intramyometrial Injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Intraoperative and Postoperative Blood Loss
Total blood loss will be assessed as the sum of intraoperative and postoperative blood loss during abdominal myomectomy. Intraoperative blood loss will be estimated using a gravimetric method by weighing surgical swabs and measuring blood volume collected in suction devices. Postoperative blood loss will be measured as the volume collected in the intraperitoneal suction drain.
Measured: From the start of surgery until removal of the intraperitoneal drain (up to 48 hours postoperatively)
Secondary outcomes (6)
Need for Blood Transfusion
The proportion of participants requiring intraoperative or postoperative blood transfusion will be recorded based on clinical condition and predefined laboratory criteria.
Measured: Intraoperative period and through postoperative day 2 (up to 48 hours after surgery)
Change in Postoperative Hemoglobin and Hematocrit Levels
Hemoglobin and hematocrit levels will be measured preoperatively and on the second postoperative day to assess perioperative blood loss and the development of postoperative anemia.
Measured: Baseline (preoperative) and postoperative day 2 (≈48 hours after surgery)
Incidence of Drug-Related Side Effects
The occurrence of adverse effects potentially related to the study drugs, including nausea, vomiting, diarrhea, shivering, headache, and cardiovascular effects, will be monitored and recorded.
Measured: Time Frame: From drug administration through postoperative day 2 or hospital discharge, whichever occurs first (up to 72 hours)
Duration of Surgery
The total operative time will be recorded from skin incision to skin closure to assess surgical efficiency.
Measured: During the surgical procedure
Postoperative Febrile Morbidity
The incidence of postoperative fever will be recorded as an indicator of infection or other postoperative complications.
Measured: From end of surgery through postoperative day 3 (up to 72 hours after surgery)
Length of Postoperative Hospital Stay
The duration of hospital stay will be measured in days from the date of surgery until discharge.
Measured: From date of surgery to hospital discharge (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start18 Jan 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a parallel-group interventional clinical trial. Eligible participants undergoing abdominal myomectomy will be randomly assigned in a 1:1 allocation ratio to one of two intervention arms. Each participant will receive only one study intervention, and no crossover between treatment arms will occur during the study period. The parallel design allows for a direct comparison between intramyometrial methylergometrine and intramyometrial carbetocin, with both interventions administered at the same intraoperative time point and under identical surgical conditions. This model minimizes contamination between treatment arms and ensures that observed differences in blood loss and perioperative outcomes can be attributed to the assigned uterotonic agent. Randomization will be performed using a computer-generated randomization sequence, and allocation concealment will be maintained through the use of sequentially numbered opaque sealed envelopes. Double blinding will be i
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kafrelsheikh University
- Responsible party
- Principal investigator, ahmed nagy shaker ramadan, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390864
- Sponsor's protocol ID
- Fayoum-MD-2024
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet determined whether de-identified individual participant data (IPD) will be shared. If sharing is approved, only de-identified IPD necessary to reproduce the primary analyses may be made available to qualified researchers, and results will also be reported in aggregate form in publications.
Publications
Taher A, Farouk D, Mohamed Kotb MM, Ghamry NK, Kholaif K, A Mageed A Allah A, Ali AS, Osman OM, Nabil H, Islam Y, Bakry MS, Islam BA, Alalfy M, Nassar SA, Bosilah AH, Ghanem AA, Ali Rund NM, Refaat R, Abdel Wahed Ali HA, Bakry A, Ashour ASA, Nabil M, Zaki SS. Evaluating efficacy of intravenous carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial. Fertil Steril. 2021 Mar;115(3):793-801. doi: 10.1016/j.fertnstert.2020.09.132. Epub 2021 Jan 16.
PubMed 33461754Gallos I, Williams H, Price M, Pickering K, Merriel A, Tobias A, Lissauer D, Gee H, Tuncalp O, Gyte G, Moorthy V, Roberts T, Deeks J, Hofmeyr J, Gulmezoglu M, Coomarasamy A. Uterotonic drugs to prevent postpartum haemorrhage: a network meta-analysis. Health Technol Assess. 2019 Feb;23(9):1-356. doi: 10.3310/hta23090.
PubMed 30821683Spencer SPE, Lowe SA. Ergometrine for postpartum hemorrhage and associated myocardial ischemia: Two case reports and a review of the literature. Clin Case Rep. 2019 Nov 6;7(12):2433-2442. doi: 10.1002/ccr3.2516. eCollection 2019 Dec.
PubMed 31893076Hickman LC, Kotlyar A, Shue S, Falcone T. Hemostatic Techniques for Myomectomy: An Evidence-Based Approach. J Minim Invasive Gynecol. 2016 May-Jun;23(4):497-504. doi: 10.1016/j.jmig.2016.01.026. Epub 2016 Mar 9.
PubMed 26855249Kim T, Purdy MP, Kendall-Rauchfuss L, Habermann EB, Bews KA, Glasgow AE, Khan Z. Myomectomy associated blood transfusion risk and morbidity after surgery. Fertil Steril. 2020 Jul;114(1):175-184. doi: 10.1016/j.fertnstert.2020.02.110. Epub 2020 Jun 10.
PubMed 32532486Donnez J, Taylor HS, Marcellin L, Dolmans MM. Uterine fibroid-related infertility: mechanisms and management. Fertil Steril. 2024 Jul;122(1):31-39. doi: 10.1016/j.fertnstert.2024.02.049. Epub 2024 Mar 5.
PubMed 38453041Uimari O, Subramaniam KS, Vollenhoven B, Tapmeier TT. Uterine Fibroids (Leiomyomata) and Heavy Menstrual Bleeding. Front Reprod Health. 2022 Mar 4;4:818243. doi: 10.3389/frph.2022.818243. eCollection 2022.
PubMed 36303616Eltoukhi HM, Modi MN, Weston M, Armstrong AY, Stewart EA. The health disparities of uterine fibroid tumors for African American women: a public health issue. Am J Obstet Gynecol. 2014 Mar;210(3):194-9. doi: 10.1016/j.ajog.2013.08.008. Epub 2013 Aug 11.
PubMed 23942040Ahmad A, Kumar M, Bhoi NR, Badruddeen, Akhtar J, Khan MI, Ajmal M, Ahmad M. Diagnosis and management of uterine fibroids: current trends and future strategies. J Basic Clin Physiol Pharmacol. 2023 Mar 30;34(3):291-310. doi: 10.1515/jbcpp-2022-0219. eCollection 2023 May 1.
PubMed 36989026Yang Q, Ciebiera M, Bariani MV, Ali M, Elkafas H, Boyer TG, Al-Hendy A. Comprehensive Review of Uterine Fibroids: Developmental Origin, Pathogenesis, and Treatment. Endocr Rev. 2022 Jul 13;43(4):678-719. doi: 10.1210/endrev/bnab039.
PubMed 34741454
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramyometrial Ergometrine Injection Versus Intramyometrial Carbetocin Injection to Decrease Blood Loss During and After Abdominal Myomectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07390864
- Acronym / sponsor ID
- Fayoum-MD-2024
- Conditions
- Myoma;Uterus
- Keywords
- Ergometrine, Carbetocin, Blood Loss, Abdominal Myomectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kafrelsheikh University
- Study start
- 18 Jan 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 5 Feb 2026 (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.
The goal of this randomized clinical trial is to determine whether intramyometrial ergometrine injection or intramyometrial carbetocin injection is more effective in reducing blood loss during and after abdominal myomectomy in women undergoing surgery for symptomatic uterine fibroids.
The main questions it aims to answer are:
Does intramyometrial ergometrine reduce intraoperative and postoperative blood loss during abdominal myomectomy?
Does intramyometrial carbetocin reduce intraoperative and postoperative blood loss during abdominal myomectomy?
Is there a difference between the two drugs in the need for blood transfusion and postoperative hemoglobin drop?
Researchers will compare intramyometrial ergometrine injection with intramyometrial carbetocin injection to see which intervention is more effective in controlling surgical bleeding and improving surgical outcomes.
Participants will:
Undergo abdominal myomectomy for uterine fibroids
Receive either intramyometrial ergometrine or intramyometrial carbetocin during surgery
Be monitored for intraoperative blood loss, postoperative blood loss, hemoglobin changes, and need for blood transfusion
Detailed description
Uterine leiomyomas are the most common benign tumors of the female reproductive tract and frequently require surgical management when symptomatic. Abdominal myomectomy remains the standard fertility-preserving surgical option for women with large or multiple intramyometrial fibroids. However, excessive intraoperative and postoperative blood loss continues to be a major challenge during myomectomy and is associated with increased morbidity, blood transfusion requirements, prolonged hospitalization, and delayed recovery.
Several pharmacological and surgical strategies have been investigated to minimize blood loss during myomectomy, including mechanical tourniquets, vasoconstrictors, uterine artery occlusion, and uterotonic agents. Among uterotonics, methylergometrine maleate and carbetocin are well-established agents that induce sustained uterine contractions and may reduce bleeding by compressing uterine vasculature. Methylergometrine, an ergot alkaloid, has long been used in obstetric hemorrhage, while carbetocin, a long-acting oxytocin analogue, offers prolonged uterotonic activity with a favorable pharmacokinetic profile. Despite their individual use, comparative data on their intramyometrial administration during abdominal myomectomy remain limited.
This prospective, double-blind, randomized comparative clinical trial is designed to evaluate and compare the effectiveness of intramyometrial methylergometrine versus intramyometrial carbetocin in reducing blood loss during and after abdominal myomectomy. The study will be conducted at Fayoum University maternity hospitals over an anticipated period of 20 months. To minimize bias, all procedures will be performed by the same surgical team following a standardized operative technique.
Participants will be randomly allocated to one of two intervention arms. In the first arm, methylergometrine maleate diluted in saline will be injected intramyometrially around the myoma before uterine incision. In the second arm, carbetocin diluted in saline will be administered in the same intramyometrial manner. The injections will be given circumferentially around the myoma, approximately 1-2 cm from its margins, and repeated as needed according to the number of myomas. Allocation concealment will be ensured using sequentially numbered opaque sealed envelopes, and double blinding will be maintained by coding the study drugs, with the allocation key retained by a designated supervisor until study completion.
A standardized abdominal myomectomy technique will be used in all cases, including Pfannenstiel incision, careful enucleation of myomas, meticulous hemostasis, layered uterine closure, and routine use of intraperitoneal drainage. Intraoperative blood loss will be quantified using a gravimetric method combined with suction measurements, while postoperative blood loss will be assessed via drain output. Perioperative monitoring will include vital signs, laboratory investigations, and clinical assessment for adverse events.
Safety monitoring will focus on drug-related side effects, hemodynamic changes, thromboembolic manifestations, and postoperative complications. The need for intraoperative or postoperative blood transfusion will be determined according to predefined clinical and laboratory criteria. Participants will be followed postoperatively until discharge and reassessed during early follow-up to ensure recovery and detect delayed complications.
The findings of this study are expected to provide evidence-based guidance on the optimal intramyometrial uterotonic agent for reducing blood loss during abdominal myomectomy, thereby improving surgical safety and patient outcomes in gynecologic practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a parallel-group interventional clinical trial. Eligible participants undergoing abdominal myomectomy will be randomly assigned in a 1:1 allocation ratio to one of two intervention arms. Each participant will receive only one study intervention, and no crossover between treatment arms will occur during the study period. The parallel design allows for a direct comparison between intramyometrial methylergometrine and intramyometrial carbetocin, with both interventions administered at the same intraoperative time point and under identical surgical conditions. This model minimizes contamination between treatment arms and ensures that observed differences in blood loss and perioperative outcomes can be attributed to the assigned uterotonic agent. Randomization will be performed using a computer-generated randomization sequence, and allocation concealment will be maintained through the use of sequentially numbered opaque sealed envelopes. Double blinding will be i
| Arm | Type | Receives |
|---|---|---|
| Intramyometrial Ergometrine Injection | Active comparator | Drug: Methylergometrine (Intramyometrial Injection)Participants receive intramyometrial injection of methylergometrine maleate diluted in saline and administered circumferentially around the myoma before uterine incision during abdominal myomectomy. |
| Intramyometrial Carbetocin Injection | Experimental | Drug: Carbetocin (Intramyometrial Injection)Participants receive intramyometrial injection of carbetocin diluted in saline and administered circumferentially around the myoma before uterine incision during abdominal myomectomy. |
Who may qualify
- Ages
- 25 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female participants aged 25 to 48 years
- Body mass index (BMI) < 35 kg/m²
- Symptomatic uterine fibroids requiring surgical management (e.g., abnormal uterine bleeding, pelvic pain, or pressure symptoms)
- Intramyometrial uterine myomas classified as FIGO types 3 to 6, diagnosed by transvaginal ultrasonography or magnetic resonance imaging
- Maximum diameter of the largest myoma ≤ 20 cm
Key exclusion criteria (16 listed)
- FIGO type 0, 1, 2, 7, or 8 myomas (intracavitary, submucosal, pedunculated subserosal, cervical, or adnexal)
- History of pelvic inflammatory disease, peritonitis, or significant abdominal or pelvic infection
- History of prior uterine surgery
- Use of hormonal treatment within 3 months prior to enrollment
- Contraindication to methylergometrine or carbetocin, including:
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 |
|---|---|---|
| Methylergometrine (Intramyometrial Injection)Also: Methylergometrine maleate, Ergometrine, MethergineMethylergometrine maleate is administered as an intramyometrial injection diluted in normal saline and injected circumferentially around the myoma before uterine incision during abdominal myomectomy to induce sustained uterine contraction and reduce surgical blood loss. | Drug | Intramyometrial Ergometrine Injection |
| Carbetocin (Intramyometrial Injection)Also: Carbetocin, Long-acting oxytocin analogueCarbetocin is administered as an intramyometrial injection diluted in normal saline and injected circumferentially around the myoma before uterine incision during abdominal myomectomy to promote sustained uterine contraction and reduce intraoperative and postoperative blood loss. | Drug | Intramyometrial Carbetocin Injection |
Primary outcome
Estimated Intraoperative and Postoperative Blood Loss
Time frame: From the start of surgery until removal of the intraperitoneal drain (up to 48 hours postoperatively)
Total blood loss will be assessed as the sum of intraoperative and postoperative blood loss during abdominal myomectomy. Intraoperative blood loss will be estimated using a gravimetric method by weighing surgical swabs and measuring blood volume collected in suction devices. Postoperative blood loss will be measured as the volume collected in the intraperitoneal suction drain.
6 secondary outcomes
Need for Blood Transfusion
Time frame: Intraoperative period and through postoperative day 2 (up to 48 hours after surgery)
Change in Postoperative Hemoglobin and Hematocrit Levels
Time frame: Baseline (preoperative) and postoperative day 2 (≈48 hours after surgery)
Incidence of Drug-Related Side Effects
Time frame: Time Frame: From drug administration through postoperative day 2 or hospital discharge, whichever occurs first (up to 72 hours)
Duration of Surgery
Time frame: During the surgical procedure
Postoperative Febrile Morbidity
Time frame: From end of surgery through postoperative day 3 (up to 72 hours after surgery)
Length of Postoperative Hospital Stay
Time frame: From date of surgery to hospital discharge (up to 7 days)
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 5 Feb 2026.
- Results publication: PubMed 33461754Taher A, Farouk D, Mohamed Kotb MM, Ghamry NK, Kholaif K, A Mageed A Allah A, Ali AS, Osman OM, Nabil H, Islam Y, Bakry MS, Islam BA, Alalfy M, Nassar SA, Bosilah AH, Ghanem AA, Ali Rund NM, Refaat R, Abdel Wahed Ali HA, Bakry A, Ashour ASA, Nabil M, Zaki SS. Evaluating efficacy of intravenous carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial. Fertil Steril. 2021 Mar;115(3):793-801. doi: 10.1016/j.fertnstert.2020.09.132. Epub 2021 Jan 16.
- Results publication: PubMed 30821683Gallos I, Williams H, Price M, Pickering K, Merriel A, Tobias A, Lissauer D, Gee H, Tuncalp O, Gyte G, Moorthy V, Roberts T, Deeks J, Hofmeyr J, Gulmezoglu M, Coomarasamy A. Uterotonic drugs to prevent postpartum haemorrhage: a network meta-analysis. Health Technol Assess. 2019 Feb;23(9):1-356. doi: 10.3310/hta23090.
- Results publication: PubMed 31893076Spencer SPE, Lowe SA. Ergometrine for postpartum hemorrhage and associated myocardial ischemia: Two case reports and a review of the literature. Clin Case Rep. 2019 Nov 6;7(12):2433-2442. doi: 10.1002/ccr3.2516. eCollection 2019 Dec.
- Results publication: PubMed 26855249Hickman LC, Kotlyar A, Shue S, Falcone T. Hemostatic Techniques for Myomectomy: An Evidence-Based Approach. J Minim Invasive Gynecol. 2016 May-Jun;23(4):497-504. doi: 10.1016/j.jmig.2016.01.026. Epub 2016 Mar 9.
- Results publication: PubMed 32532486Kim T, Purdy MP, Kendall-Rauchfuss L, Habermann EB, Bews KA, Glasgow AE, Khan Z. Myomectomy associated blood transfusion risk and morbidity after surgery. Fertil Steril. 2020 Jul;114(1):175-184. doi: 10.1016/j.fertnstert.2020.02.110. Epub 2020 Jun 10.
- Results publication: PubMed 38453041Donnez J, Taylor HS, Marcellin L, Dolmans MM. Uterine fibroid-related infertility: mechanisms and management. Fertil Steril. 2024 Jul;122(1):31-39. doi: 10.1016/j.fertnstert.2024.02.049. Epub 2024 Mar 5.
- Results publication: PubMed 36303616Uimari O, Subramaniam KS, Vollenhoven B, Tapmeier TT. Uterine Fibroids (Leiomyomata) and Heavy Menstrual Bleeding. Front Reprod Health. 2022 Mar 4;4:818243. doi: 10.3389/frph.2022.818243. eCollection 2022.
- Results publication: PubMed 23942040Eltoukhi HM, Modi MN, Weston M, Armstrong AY, Stewart EA. The health disparities of uterine fibroid tumors for African American women: a public health issue. Am J Obstet Gynecol. 2014 Mar;210(3):194-9. doi: 10.1016/j.ajog.2013.08.008. Epub 2013 Aug 11.
- Results publication: PubMed 36989026Ahmad A, Kumar M, Bhoi NR, Badruddeen, Akhtar J, Khan MI, Ajmal M, Ahmad M. Diagnosis and management of uterine fibroids: current trends and future strategies. J Basic Clin Physiol Pharmacol. 2023 Mar 30;34(3):291-310. doi: 10.1515/jbcpp-2022-0219. eCollection 2023 May 1.
- Results publication: PubMed 34741454Yang Q, Ciebiera M, Bariani MV, Ali M, Elkafas H, Boyer TG, Al-Hendy A. Comprehensive Review of Uterine Fibroids: Developmental Origin, Pathogenesis, and Treatment. Endocr Rev. 2022 Jul 13;43(4):678-719. doi: 10.1210/endrev/bnab039.
- Individual participant dataSharing planned: Undecided. It is not yet determined whether de-identified individual participant data (IPD) will be shared. If sharing is approved, only de-identified IPD necessary to reproduce the primary analyses may be made available to qualified researchers, and results will also be reported in aggregate form in publications.
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Epidemiology and Risk Factors of Uterine Fibroids in China
Uterine Fibroid
RecruitingObservational study
The Effects of Uterine Fibroids on Pregnancy in Women
Female Infertility, Uterine Fibroid
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 Methylergometrine (Intramyometrial Injection) and Carbetocin (Intramyometrial Injection) 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 7 inclusion and 16 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 5 Feb 2026. 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.
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 Ahmed E Abd eltawab, MD (+201091355562, aea11@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Intraoperative and Postoperative Blood Loss (time frame: From the start of surgery until removal of the intraperitoneal drain (up to 48 hours postoperatively)). 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 NCT07390864, which also lists 10 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 5 Feb 2026.