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To evaluate the effects of oxytocin infusion during abdominal myomectomy.
Myomectomy is indicated for symptomatic uterine fibroids. Fibroids have blood supply and 20% of the abdominal myomectomy cases might require blood transfusion because of the nature of the surgery. Oxytocin infusion is one of the intervention to decrease blood loss during myomectomy. To evaluate the effects and benefits of oxytocin infusion during abdominal myomectomy we decide to conduct this randomized study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin infusion | Experimental | Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia. |
|
| Placebo | Placebo Comparator | Patients will receive pure normal saline infusion at the same rate and volume just before the surgery after the induction of general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss during surgery | estimated blood loss during the surgery measured by aspiration fluid. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss after abdominal myomectomy | change in Hematocrit Percentage (before and after the surgery) | 1 hour postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
Female patients with uterus and undergoing abdominal myomectomy
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| Name | Affiliation | Role |
|---|---|---|
| Berna Aslan | Kanuni Sultan Suleyman Research and Training Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanuni Sultan Suleyman Egitim ve Arastırma Hastanesi | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27862855 | Result | Atashkhoei 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. | |
| 16398771 | Result | Chang FW, Yu MH, Ku CH, Chen CH, Wu GJ, Liu JY. Effect of uterotonics on intra-operative blood loss during laparoscopy-assisted vaginal hysterectomy: a randomised controlled trial. BJOG. 2006 Jan;113(1):47-52. doi: 10.1111/j.1471-0528.2005.00804.x. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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The abdominal myomectomy cases will be randomized into 2 separate groups in a parallel fashion using an online software at 1:1 ratio.
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Randomization will be performed by an online software and the list will be given to anesthesiologist so that neither the surgeon nor patient will know which intervention was performed. Randomized cards will be in sealed envelopes and will be open by anesthesiologist at the time of surgery.
| saline | Other | Patients will receive intravenous normal saline infusion just before the surgery after the induction of general anesthesia. |
|
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |