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The Efficacy and Safety of Preoperative Misoprostol in Blood-loss Reduction During Myomectomy. (MM)

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ClinicalTrials.gov Identifier: NCT03509168
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
College of Health Sciences, Makerere University

Brief Summary:

Open myomectomy remains the principal treatment for symptomatic fibroids in sub-Saharan countries irrespective of fertility desires. This however has got to be balanced against potential risks such as profuse hemorrhage; blood loss at open myomectomy remains dreary with the use of various pharmacologic agents yielding inconclusive results. This trial is aimed at exploring the benefit of preoperative use of a readily available uterotonic, Misoprostol in reduction of intraoperative blood loss during open myomectomy with the Null hypothesis stating: there is no difference in mean blood loss during open myomectomy whether one preoperatively inserts a single dose of 400mcg vaginal misoprostol or not.

Alternate hypothesis: single dose 400mcg vaginal Misoprostol given 60 minutes preoperatively during open myomectomy reduces intra-operative blood loss by at least 20% as measured by surgical mops and suction.

Participants from two referral hospitals in Uganda with symptomatic fibroids and scheduled for open myomectomy will be recruited. 48 women that meet the inclusion criteria and have none of the exclusion criteria and provide signed informed consent will be enrolled. The screening will be done on the gynecological wards and patients will be randomized to either the control or interventional arm by means of sealed, sequentially numbered opaque envelopes containing computer-generated random numbers. Blinding will affect theatre team and patients. Primary (blood loss as estimated by surgical mops and suction) and secondary endpoints (e.g. postoperative drop in Hb) will be calculated. Data analysis: Data will be analyzed on an intention-to-treat basis. Analysis will be done using STATA software 14.0. This will include descriptive statistics for measures of central tendency and dispersion. Student t-test and Mann Whitney U test will be used for mean blood loss. Stratification for age, parity, complaints, total fibroid mass and usage of other intraoperative blood-loss techniques will be analyzed. categorical data to be analyzed by coefficients.

Results of this study are meant to better inform clinicians about the use of misoprostol for this role and possibly include it in the management protocols for open myomectomy in Sub-Saharan countries where burden of blood products is strained.


Condition or disease Intervention/treatment Phase
Uterine Fibroid Drug: Misoprostol Pfizer Brand Other: Non-insertion of Misoprostol Pfizer Brand Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicenter-randomized single blind controlled trial with a (1:1) allocation ratio.
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Pre-operative Vaginal Misoprostol in Reduction of Intraoperative Blood Loss During Myomectomy. Amulticentre Single Blind Randomized Trial.
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : June 3, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Active Comparator: Misoprostol Pfizer Brand arm
participants receive a single dose of 400mcg vaginal misoprostol preoperatively (60minutes before) during open myomectomy
Drug: Misoprostol Pfizer Brand
insertion of a preoperative single dose 400 micrograms of Misoprostol Pfizer Brand placed vaginally
Other Name: cytotec

No misoprostol arm
standard of care
Other: Non-insertion of Misoprostol Pfizer Brand
participants in this arm will receive the standard of care which in our setting involves the use of either a tourniquet to control intraoperative blood loss especially if the fibroids are large or rarely, other interventions like oxytocin, tranexamic acid, vasopressin and occasionally not using either of the interventions.




Primary Outcome Measures :
  1. intraoperative blood loss during open myomectomy in milliliters [ Time Frame: immediate post-operative ]
    Soaked mops will be weighed and blood loss estimated by subtracting the soaked weight from the dry weight and by multiplying this by 1.060 (average density of human blood is 1.06g/ml); a volume in ml would be acquired. Only mops are intended to be routinely used during the operation for cleaning and clearing the operation field although measurement of blood collected in the suction cylinder in milliliters if used will also be added. Adequate mops will be provided to avoid any spillage onto the operating table polythene sheet. A standardized digital weighing scale will be availed in each operating room. Any spillage onto the bed, however, will be collected in a polythene sheet and poured into a measuring cylinder for quantification.


Secondary Outcome Measures :
  1. duration of surgery [ Time Frame: immediate postoperative ]
    from incision time to time for insertion of last stitch

  2. duration of hospital stay [ Time Frame: 4th postoperative day. (96 hours) ]
    number of days spent within the hospital post-operatively

  3. need for blood transfusion [ Time Frame: during and within 72 hours after open myomectomy ]
    hemodynamic instability during and after open myomectomy following profuse hemorrhage as assessed by the clinicians.

  4. Serious adverse outcomes [ Time Frame: 72 hours following open myomectomy ]
    death, massive transfusion >5 units of blood, development of deep venous thrombosis pulmonary edema and pulmonary embolism

  5. drop in postoperative hemoglobin concentration [ Time Frame: hemoglobin estimation done approximately 72 hours post-operatively ]
    Hemoglobin estimation done both pre- and post-operatively; difference between the two values to be a measure of amount of blood lost. patients that receive blood transfusion to be excluded.



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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Reproductive age (15-49 years)
  • Documented symptomatic uterine fibroids by ultrasound imaging
  • Presenting to any of the selected hospitals within the study period.
  • Scheduled for open myomectomy
  • Willing to give informed consent

Exclusion Criteria:

  • Previous uterine surgeries.
  • Poorly controlled hypertension or diabetes
  • History of a bleeding disorder, concurrent anticoagulant therapy, family history of bleeding disorder, prior history of deep venous thrombosis.
  • Pregnancy
  • Hemoglobin less than 10.5 g/dL at the time of surgery
  • Prior treatment using GnRH analogues
  • Intra-operative exclusion; pelvic endometriosis, adenomyosis, pelvic abcesses, pelvic malignancies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509168


Contacts
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Contact: Moses Mugisha +256774731973 mugisha5964@gmail.com
Contact: Josephat Byamugisha +256772580330 jbyamugisha@gmail.com

Locations
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Uganda
Makerere University Recruiting
Kampala, Central, Uganda, +256
Contact: Moses Mugisha    +256774731973    mugisha5964@gmail.com   
Contact: Josephat Byamugisha, Professor    +256772580330    jbyamugisha@gmail.com   
Sponsors and Collaborators
Makerere University
Investigators
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Principal Investigator: Moses Mugisha Makerere University
Study Chair: Josephat Byamugisha, Professor Makerere University

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Responsible Party: College of Health Sciences, Principal Investigator, Makerere University
ClinicalTrials.gov Identifier: NCT03509168     History of Changes
Other Study ID Numbers: myomectomy trial
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics