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

NCT03509168 | Unknown Phase 2 DMC

• 1 other identifier: myomectomy trial
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Fibroid

Outcome Measures

Primary Outcomes (1)

• intraoperative blood loss during open myomectomy in milliliters

  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.

  immediate post-operative

Secondary Outcomes (5)

• duration of surgery

  immediate postoperative

• duration of hospital stay

  4th postoperative day. (96 hours)

• need for blood transfusion

  during and within 72 hours after open myomectomy

• Serious adverse outcomes

  72 hours following open myomectomy

• drop in postoperative hemoglobin concentration

  hemoglobin estimation done approximately 72 hours post-operatively

Study Arms (2)

Misoprostol Pfizer Brand arm

ACTIVE COMPARATOR

participants receive a single dose of 400mcg vaginal misoprostol preoperatively (60minutes before) during open myomectomy

Drug: Misoprostol Pfizer Brand

No misoprostol arm

OTHER

standard of care

Other: Non-insertion of Misoprostol Pfizer Brand

Interventions

Misoprostol Pfizer Brand DRUG

insertion of a preoperative single dose 400 micrograms of Misoprostol Pfizer Brand placed vaginally

Also known as: cytotec

Misoprostol Pfizer Brand arm

Non-insertion of Misoprostol Pfizer Brand OTHER

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.

No misoprostol arm

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Makerere University

Kampala, Central Region, +256, Uganda

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Moses Mugisha

  Makerere University

  PRINCIPAL INVESTIGATOR

• Josephat Byamugisha, Professor

  Makerere University

  STUDY CHAIR

Central Study Contacts

Moses Mugisha

CONTACT

+256774731973; mugisha5964@gmail.com

Josephat Byamugisha

CONTACT

+256772580330; jbyamugisha@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: multicenter-randomized single blind controlled trial with a (1:1) allocation ratio.

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 26, 2018
• Study Start: January 10, 2018
• Primary Completion: May 30, 2018
• Study Completion: June 3, 2018
• Last Updated: April 30, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)