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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||multicenter-randomized single blind controlled trial with a (1:1) allocation ratio.|
|Masking:||Double (Participant, Care Provider)|
|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|
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.
- 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.
- duration of surgery [ Time Frame: immediate postoperative ]from incision time to time for insertion of last stitch
- duration of hospital stay [ Time Frame: 4th postoperative day. (96 hours) ]number of days spent within the hospital post-operatively
- 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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509168
|Contact: Moses Mugishaemail@example.com|
|Contact: Josephat Byamugishafirstname.lastname@example.org|
|Kampala, Central, Uganda, +256|
|Contact: Moses Mugisha +256774731973 email@example.com|
|Contact: Josephat Byamugisha, Professor +256772580330 firstname.lastname@example.org|
|Principal Investigator:||Moses Mugisha||Makerere University|
|Study Chair:||Josephat Byamugisha, Professor||Makerere University|