Comparing Preoperative Vaginal Misoprostol, Intraoperative Oxytocin Infusion, Intravenous Carbetocin and Pericervical Hemostatic Tourniquet in Reducing Blood Loss During Abdominal Myomectomy, a Randomized Controlled Trial
Sponsor study identifier
interventional
120
0 countries
N/A
Study Start
November 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of the study is to compare the effectiveness of a single preoperative dose of vaginal misoprostol, intraoperative oxytocin infusion, IV carbetocin and pericervical tourniquet for the reduction of blood loss during of abdominal myomectomy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 8, 2020
Actual (reported)October 22, 2020
Actual (reported)November 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Intraoperative blood loss
estimated by calculating the sum of canisters containing irrigation fluids and suctioned (ml)blood minus used irrigation solution plus the amount of absorbed blood in used sponges then converting weight with volume of blood loss as \[post-operative wet sponge weight in (grams) minus preoperative dry sponge weight (grams) which means 1 ml of blood weighs 1gm\].
baseline
The need for blood transfusion
baseline
Preoperative and postoperative haemoglobin and haematocrit values
24 hours before and 24 hours after
Perioperative blood pressure and HR
Up to 4 hours postoperative
Time of ambulation
within 12 hours postoperative
Post-operative hospital stay
within 3 days postoperative
receive two tablets of 200µg misoprostol (Pfizer Limited, United Kingdom) administered into the posterior fornix of the vagina 1 hour before the onset of surgery
After induction of general anaesthesia and immediately prior to the operation, an infusion of 30 IU oxytocin in 500 ml normal saline at a rate of 120 ml/h will be started during myomectomy.
receive 100 μg IV Carbetocin (1ml) \[Pabal, Ferring (UK)\] in 5 ml saline over 1 minute just before skin incision
2 tablets vaginally 1 hour before surgery
Abdel-Hafeez M, Elnaggar A, Ali M, Ismail AM, Yacoub M. Rectal misoprostol for myomectomy: A randomised placebo-controlled study. Aust N Z J Obstet Gynaecol. 2015 Aug;55(4):363-8. doi: 10.1111/ajo.12359. Epub 2015 Jul 14.
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.
Ahmed Ibrahim Aref, professor
Kasr Alainy Cairo University
Soumaya Mohamed AbouElew, professor
Kasr Alainy Cairo University
First Submitted
October 8, 2020
First Posted
October 22, 2020
Study Start
November 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma
pericervical tourniquet using a Foley catheter size 18, which will be firmly tied at the level of the cervico-isthmic junction of the uterus before the uterine incision.
100 μg IV Carbetocin (1ml) in 5 ml saline over 1 minute
a Foley catheter size 18, which will be firmly tied at the level of the cervico-isthmic junction of the uterus before the uterine incision,The time of tourniquet administration will be recorded, and will be released not later than 45 minutes after its application. For those requiring multiple applications, the tourniquet will be reapplied after a period of at least 15 minutes.
Contact the study team to confirm eligibility.
Farouk H, Shady N (2017) Intravenous Carbetocin to decrease blood loss during open myomectomy: a randomized placebo-controlled study. IJRCOG 7:
Gad Allah, S. H., A Wali, A., & Mostafa, S. (2015). Hemostatic effect and postoperative benefits of intramyometrial carbetocin injection during myomectomy: a randomized controlled trial. Evidence Based Women's Health Journal, 5(4), 185-189.
Gharabaghi PM, Alizadeh S, Atashkhoye S, Sayyah-Melli M, Jafari- Shobeiri M, Ouladsahebmadarek E, et al. Comparing the Outcomes and Side Effects of Administration of a Single Preoperative Dose of Vaginal Misoprostol With Intraoperative Oxytocin Infusion in Blood Loss During Abdominal Myomectomy. Int J Women's Health Reprod Sci 2017;
Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5.
Ragab A, Khaiary M, Badawy A. The Use of Single Versus Double Dose of Intra-vaginal Prostaglandin E2 "Misoprostol" prior to Abdominal Myomectomy: A Randomized Controlled Clinical Trial. J Reprod Infertil. 2014 Jul;15(3):152-6.
Primary Completion
August 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 22, 2020
Record last verified: 2020-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: