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

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

Interventions

DRUG

Misoprostol Pfizer Brand

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

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.

Sponsors & Collaborators

• Makerere University

  lead OTHER

Principal Investigators

• Moses Mugisha · Makerere University

• Josephat Byamugisha, Professor · Makerere University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-10

Primary Completion

2018-05-30

Completion

2018-06-03

Countries

• Uganda

Study Locations