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

• Status: Unknown status
• Trial end date: 2018-06-03
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Makerere University
• Treatments: Misoprostol

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