Use of Misoprostol in Hysteroscopic Myomectomy
ConditionHysteroscopic Myomectomy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-55
SponsorAssuta Ashdod Hospital
About this trial
Hysteroscopic myomectomy is typically suitable for myomas measuring under 4 cm in size. The utilization of misoprostol before the procedure can facilitate uterine access, decrease fluid absorption, and reduce blood loss, consequently leading to a decrease in the overall procedure time. In this randomized trial, the investigators aim to investigate the impact of misoprostol administration and its effects on each of the mentioned parameters.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
women between the ags of 20 years- 55 years, inclusive
undergoing hysteroscopic myomectomy
submucosal fibroid less than 40 mm (type 0, 1 and 2)
up to 2 submucosal fibroids
Disqualifiers
post menopausal women
inability to perform operative hysteroscopy under anesthesia in the past due to cervical stenosis
previous PID or documented tubal occlusion
positive BHCG test
Trial design
Design model
Parallel
Treatments tested in this trial
Misoprostol 400 Microgram Oral Tablet
DrugS.L misoprostol 400 mcg
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: hysteroscopic myomectomy without misoprostolNo intervention 0 interventions
Group B: Misoprostol groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
length of the procedure
overall procedure time
Time frame
from the first insertion of the hysteroscope to the end of the procedure, minutesSecondary outcomes
1
fluid absorption
fluid deficit as measured within the procedure
Time frame
from the start of the procedure to the end of the procedure2
success in one procedure
complete removal of the fibroid in a one step procedure
Time frame
from the start of the procedure to the end of the procedure3
surgical complications
surgical complications according to the Dindo-Clavien scale
Time frame
1 month folowing the procedure4
patient satisfaction
satisfaction from the procedure on a scale of 1-10
Time frame
within 30 days of the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assuta Ashdod Hospital
Lead sponsor
Assuta Medical Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: