LeiomyomaoxytocinNCT04996498
Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy
A study testing Oxytocin and sterile bacteriostatic water ampule in people with Leiomyoma, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
There is no previous study on the hemostatic effect of intrauterine instillation of oxytocin in hysteroscopic myomectomy. All previous studies focused on intravenous administration of oxytocin. Read more about this study
- Who is it for?
- Ages Up to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyoma
- What is being tested?
- Oxytocin and sterile bacteriostatic water ampule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2021to 1 Oct 2022
- 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 Up to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Symptomatic patient (Menorrhagia, recurrent pregnancy loss or infertility).
- 1 or 2 submucous uterine myoma diagnosed by ultrasound with a diameter less than 4 cm
- Myoma with FIGO 0 or 1.
- Body mass index less than 35.
Who cannot join
- Pregnancy
- Active pelvic infection
- history of bleeding disorder or patient on anti-coagulant.
- hepatic and renal diseases.
- history of ischemic heart disease.
- Patients with uterine structural abnormality or uterine septum.
Show all 10Show fewer
- Present or history of cervical or uterine cancer.
- Preoperative administration of gonadotropin-releasing hormone analogues or danazol.
- Allergy to glycine.
- Patients with hypercoagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy: A Randomized Double Blinded Control Trial
There is no previous study on the hemostatic effect of intrauterine instillation of oxytocin in hysteroscopic myomectomy. All previous studies focused on intravenous administration of oxytocin.
This trial may modify the surgical environment in hysteroscopic myomectomy by decreasing intraoperative bleeding to a degree that the amount of distention medium required for uterine distention will be reduced with a better visibility and shorter operation time.
Read more
The standard treatment of symptomatic myomas is hysterectomy for women who have completed childbearing period, and myomectomy for women who wish to preserve fertility hysteroscopic myomectomy currently is the gold standard minimally invasive procedure for the management of symptomatic submucous fibroids. Success of hysteroscopic myomectomy depends on good visualization throughout the procedure, via the correct distending pressure, continuous irrigation and the use of electrosurgery to control bleeding. Prolonged procedures that need continuous irrigation under high pressure are associated with higher risk of excessive fluid absorption and intravasation syndrome due to opened blood vessels within the myometrial, moreover, the thermal damage of the healthy tissues is increased with the use of the coagulation current.
Oxytocin receptors exist in the non-pregnant uterus but the concentration of the receptors is much lower than in pregnancy. this is why the clinical use of oxytocin outside of pregnancy is limited Oxytocin acts on oxytocin receptors in the myometrium and fibroid tissue leading to uterine contraction and constriction of uterine vasculature due to uterine contraction and vaso-constrictive effect of oxytocin thus reducing uterine perfusion and results in reducing intraoperative bleeding.
Read the detailed description
Patients will be subjected to:
- History taking: including personal history, menstrual and obstetric history, medical and surgical history, medications.
- Clinical examination; General and local with special concern about:
- Size and position of the uterus
- Transvaginal ultrasound to determine the number, size, location of fibroids and evaluation of the myometrial free margin that is defined as the minimum thickness between the outer edge of the fibroid and the inner edge of uterine serosa.
- Laboratory evaluation: All participants will have routine blood tests: Complete Blood Count (CBC), serum creatinine, viral markers, coagulation profile and liver function tests.
Surgical procedure:
- Office hysteroscopy will be performed the day before the procedure with the use of a 2-9 mm telescope with continuous-flow sheath (Hopkins II telescope 30 degrees: Karl storz) to assess and confirm the fibroid location, its intracavitary portion and to exclude any associated uterine pathology).
- Hysteroscopy will be performed in the early proliferative phase (postmenstrual) in dorsal lithotomy position under general anesthesia, cervical dilatation will be done with Hegar dilators then resection of the submucous fibroid using monopolar resectoscope using 1,5% glycine as a distension medium by single operator to avoid inter-observer variability.
- The intervention group (oxytocin group) will receive 10 IU of oxytocin for every 1000 ml of the distending medium (1,5% Glycine). While in the control group a sterile bacteriostatic water ampule in the same form will be added to every 1000 ml of the distending medium (1,5% Glycine).
- After completing the procedure, the surgeon will complete a record scale to document estimated blood loss, rating the bleeding (0: no bleeding, I; mild bleeding, II: moderate bleeding, III: severe bleeding, IV: severe bleeding with clots). Also will document the clarity of visual field using 3 point likert scale as (poor, fair, good).
- Post operative settings:
- the duration of surgery and the volume of injected media will be calculated and documented.
- all patients will be subjected to postoperative hemoglobin 24 hours after the procedure, any intraoperative or postoperative complications will be documented
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called syntocinon
intrauterine Instillation of oxytocin in distention media used during Hysteroscopic Myomectomy
sterile bacteriostatic water ampuleOther
a placebo drug similar in shape to oxytocin ampules
| Study group | Role | What they receive |
|---|---|---|
| Group A (Oxytocin group): | Active comparator | 30 women will undergo a hysteroscopic myomectomy with the use of 10 IU of oxytocin for every 1000 ml of the distending medium (1,5% Glycine ). Receives: Drug: Oxytocin |
| Group B (Placebo group): | Placebo comparator | 30 women will undergo hysteroscopic myomectomy with the use of a sterile bacteriostatic water ampule in the distending medium (1,5% glycine). Receives: Other: sterile bacteriostatic water ampule |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in hemoglobin level 24 hours after the procedure surgery
the change of hemoglobin postoperative to know the effect of oxytocin compared to placebo in reducing blood loss.
surgery compared to the pre-operative values to see if intrauterine instillation of oxytocin will reduce blood loss during hysteroscopic myomectomy
Measured: preoperative and 24 hour postoperative
the change of hematocrit level 24 hour after the procedure
a follow up CBC is done 24 hour after the procedure to see the difference in hematocrit and know about the blood loss intraoperative
Measured: preoperative and 24 hour postoperative
Secondary outcomes (5)
the surgeon rating of intraoperative bleeding and the visual field quality of operative view,
After completing the procedure, the surgeon will complete a record scale to document estimated blood loss, rating the bleeding (0: no bleeding, I; mild bleeding, II: moderate bleeding, III: severe bleeding, IV: severe bleeding with clots).
Measured: immediately postoperative
the duration of surgery, intraoperative
Success of hysteroscopic myomectomy depends on good visualization throughout the procedure, so, if oxytocin decrease blood loss intraoperative , the operation time will be reduced .
Measured: immediately postoperative
intraoperative and postoperative complications
there are some operative complications as uterine perforation , cervical tear and fluid overload also, there is some adverse effects of oxytocin as arrythmia, nausea, vomiting , hypotension and abdominal pain
Measured: intraoperative and within the first 24 hours postoperative
the surgeon rating the visual field
After completing the procedure, the surgeon will document the clarity of visual field using 3 point scale as (poor, fair, good)
Measured: immediately postoperative
the volume of distension media used intraoperative
glycine 1,5% is used as a distention media during procedure, each solution contain 1000 ml . counting the number of solution used intraoperative to calculate the amount of distension media used.
Measured: immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start15 Apr 2021
- Primary completion1 Jul 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LeiomyomaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled double blinded clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Amir Hamdy Abd El hady Mahfouz, Ain Shams Maternity Hospital
- Investigators
- amir Mahfouz, Master, Principal investigator, AinShams MH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996498
- Sponsor's protocol ID
- Hysteroscopic Myomectomy:
- Acronym
- oxytocin
- Status last verified
- Nov 2023
- First submitted
- 7 Jul 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Spiezio Sardo A, Mazzon I, Bramante S, Bettocchi S, Bifulco G, Guida M, Nappi C. Hysteroscopic myomectomy: a comprehensive review of surgical techniques. Hum Reprod Update. 2008 Mar-Apr;14(2):101-19. doi: 10.1093/humupd/dmm041. Epub 2007 Dec 6.
PubMed 18063608Vilos GA, Allaire C, Laberge PY, Leyland N; SPECIAL CONTRIBUTORS. The management of uterine leiomyomas. J Obstet Gynaecol Can. 2015 Feb;37(2):157-178. doi: 10.1016/S1701-2163(15)30338-8.
PubMed 25767949Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.
PubMed 21345435Maggi M, Magini A, Fiscella A, Giannini S, Fantoni G, Toffoletti F, Massi G, Serio M. Sex steroid modulation of neurohypophysial hormone receptors in human nonpregnant myometrium. J Clin Endocrinol Metab. 1992 Feb;74(2):385-92. doi: 10.1210/jcem.74.2.1309835.
PubMed 1309835Atashkhoei S, Fakhari S, Pourfathi H, Bilehjani E, Garabaghi PM, Asiaei A. Effect of oxytocin infusion on reducing the blood loss during abdominal myomectomy: a double-blind randomised controlled trial. BJOG. 2017 Jan;124(2):292-298. doi: 10.1111/1471-0528.14416. Epub 2016 Nov 15.
PubMed 27862855
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy: A Randomized Double Blinded Control Trial
- ClinicalTrials.gov ID
- NCT04996498
- Acronym / sponsor ID
- oxytocin / Hysteroscopic Myomectomy:
- Conditions
- Leiomyoma
- Keywords
- Hysteroscopic Myomectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 9 Aug 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.
There is no previous study on the hemostatic effect of intrauterine instillation of oxytocin in hysteroscopic myomectomy. All previous studies focused on intravenous administration of oxytocin.
This trial may modify the surgical environment in hysteroscopic myomectomy by decreasing intraoperative bleeding to a degree that the amount of distention medium required for uterine distention will be reduced with a better visibility and shorter operation time.
The standard treatment of symptomatic myomas is hysterectomy for women who have completed childbearing period, and myomectomy for women who wish to preserve fertility hysteroscopic myomectomy currently is the gold standard minimally invasive procedure for the management of symptomatic submucous fibroids. Success of hysteroscopic myomectomy depends on good visualization throughout the procedure, via the correct distending pressure, continuous irrigation and the use of electrosurgery to control bleeding. Prolonged procedures that need continuous irrigation under high pressure are associated with higher risk of excessive fluid absorption and intravasation syndrome due to opened blood vessels within the myometrial, moreover, the thermal damage of the healthy tissues is increased with the use of the coagulation current.
Oxytocin receptors exist in the non-pregnant uterus but the concentration of the receptors is much lower than in pregnancy. this is why the clinical use of oxytocin outside of pregnancy is limited Oxytocin acts on oxytocin receptors in the myometrium and fibroid tissue leading to uterine contraction and constriction of uterine vasculature due to uterine contraction and vaso-constrictive effect of oxytocin thus reducing uterine perfusion and results in reducing intraoperative bleeding.
Detailed description
Patients will be subjected to:
- History taking: including personal history, menstrual and obstetric history, medical and surgical history, medications.
- Clinical examination; General and local with special concern about:
- Size and position of the uterus
- Transvaginal ultrasound to determine the number, size, location of fibroids and evaluation of the myometrial free margin that is defined as the minimum thickness between the outer edge of the fibroid and the inner edge of uterine serosa.
- Laboratory evaluation: All participants will have routine blood tests: Complete Blood Count (CBC), serum creatinine, viral markers, coagulation profile and liver function tests.
Surgical procedure:
- Office hysteroscopy will be performed the day before the procedure with the use of a 2-9 mm telescope with continuous-flow sheath (Hopkins II telescope 30 degrees: Karl storz) to assess and confirm the fibroid location, its intracavitary portion and to exclude any associated uterine pathology).
- Hysteroscopy will be performed in the early proliferative phase (postmenstrual) in dorsal lithotomy position under general anesthesia, cervical dilatation will be done with Hegar dilators then resection of the submucous fibroid using monopolar resectoscope using 1,5% glycine as a distension medium by single operator to avoid inter-observer variability.
- The intervention group (oxytocin group) will receive 10 IU of oxytocin for every 1000 ml of the distending medium (1,5% Glycine). While in the control group a sterile bacteriostatic water ampule in the same form will be added to every 1000 ml of the distending medium (1,5% Glycine).
- After completing the procedure, the surgeon will complete a record scale to document estimated blood loss, rating the bleeding (0: no bleeding, I; mild bleeding, II: moderate bleeding, III: severe bleeding, IV: severe bleeding with clots). Also will document the clarity of visual field using 3 point likert scale as (poor, fair, good).
- Post operative settings:
- the duration of surgery and the volume of injected media will be calculated and documented.
- all patients will be subjected to postoperative hemoglobin 24 hours after the procedure, any intraoperative or postoperative complications will be documented
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled double blinded clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Group A (Oxytocin group): | Active comparator | Drug: Oxytocin30 women will undergo a hysteroscopic myomectomy with the use of 10 IU of oxytocin for every 1000 ml of the distending medium (1,5% Glycine ). |
| Group B (Placebo group): | Placebo comparator | Other: sterile bacteriostatic water ampule30 women will undergo hysteroscopic myomectomy with the use of a sterile bacteriostatic water ampule in the distending medium (1,5% glycine). |
Who may qualify
- Ages
- Up to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Symptomatic patient (Menorrhagia, recurrent pregnancy loss or infertility).
- 1 or 2 submucous uterine myoma diagnosed by ultrasound with a diameter less than 4 cm
- Myoma with FIGO 0 or 1.
- Body mass index less than 35.
Key exclusion criteria (10 listed)
- Pregnancy
- Active pelvic infection
- history of bleeding disorder or patient on anti-coagulant.
- hepatic and renal diseases.
- history of ischemic 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 |
|---|---|---|
| OxytocinAlso: syntocinonintrauterine Instillation of oxytocin in distention media used during Hysteroscopic Myomectomy | Drug | Group A (Oxytocin group): |
| sterile bacteriostatic water ampulea placebo drug similar in shape to oxytocin ampules | Other | Group B (Placebo group): |
Primary outcome
the change in hemoglobin level 24 hours after the procedure surgery
Time frame: preoperative and 24 hour postoperative
the change of hemoglobin postoperative to know the effect of oxytocin compared to placebo in reducing blood loss. surgery compared to the pre-operative values to see if intrauterine instillation of oxytocin will reduce blood loss during hysteroscopic myomectomy
the change of hematocrit level 24 hour after the procedure
Time frame: preoperative and 24 hour postoperative
a follow up CBC is done 24 hour after the procedure to see the difference in hematocrit and know about the blood loss intraoperative
5 secondary outcomes
the surgeon rating of intraoperative bleeding and the visual field quality of operative view,
Time frame: immediately postoperative
the duration of surgery, intraoperative
Time frame: immediately postoperative
intraoperative and postoperative complications
Time frame: intraoperative and within the first 24 hours postoperative
the surgeon rating the visual field
Time frame: immediately postoperative
the volume of distension media used intraoperative
Time frame: immediately postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 18063608Di Spiezio Sardo A, Mazzon I, Bramante S, Bettocchi S, Bifulco G, Guida M, Nappi C. Hysteroscopic myomectomy: a comprehensive review of surgical techniques. Hum Reprod Update. 2008 Mar-Apr;14(2):101-19. doi: 10.1093/humupd/dmm041. Epub 2007 Dec 6.
- Background: PubMed 25767949Vilos GA, Allaire C, Laberge PY, Leyland N; SPECIAL CONTRIBUTORS. The management of uterine leiomyomas. J Obstet Gynaecol Can. 2015 Feb;37(2):157-178. doi: 10.1016/S1701-2163(15)30338-8.
- Background: PubMed 21345435Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.
- Background: PubMed 1309835Maggi M, Magini A, Fiscella A, Giannini S, Fantoni G, Toffoletti F, Massi G, Serio M. Sex steroid modulation of neurohypophysial hormone receptors in human nonpregnant myometrium. J Clin Endocrinol Metab. 1992 Feb;74(2):385-92. doi: 10.1210/jcem.74.2.1309835.
- Background: PubMed 27862855Atashkhoei S, Fakhari S, Pourfathi H, Bilehjani E, Garabaghi PM, Asiaei A. Effect of oxytocin infusion on reducing the blood loss during abdominal myomectomy: a double-blind randomised controlled trial. BJOG. 2017 Jan;124(2):292-298. doi: 10.1111/1471-0528.14416. Epub 2016 Nov 15.
- practice guidelines for the diagnosis and management of submucous leiomyomas. Journal of minimally invasive gynecology,Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
amir Mahfouz, Master principal investigator
AinShams MH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin and sterile bacteriostatic water ampule in people with Leiomyoma, run by Ain Shams Maternity Hospital 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 7 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in hemoglobin level 24 hours after the procedure surgery (time frame: preoperative and 24 hour postoperative). The study lists 2 primary outcomes in all. 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 NCT04996498, which also lists 5 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 7 Nov 2023.