The Efficacy and Safety of Preoperative Misoprostol in Blood-loss Reduction During Myomectomy.
Status:
Unknown status
Trial end date:
2018-06-03
Target enrollment:
Participant gender:
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.