Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy
the Effectiveness of Preoperative Vaginal Dinoprostone in Reducing Blood Loss During Abdominal Myomectomy:a Randomized Controlled Trial
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
The aim of the study is to compare the effectiveness of vaginal dinoprostone 3 mg versus placebo before myomectomy to decrease blood loss during and after the operation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2019
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2019
CompletedFirst Posted
Study publicly available on registry
September 6, 2019
CompletedStudy Start
First participant enrolled
September 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2019
CompletedSeptember 6, 2019
September 1, 2019
3 months
September 4, 2019
September 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mean amount of intraoperative blood loss
Mean amount of intraoperative blood loss in ml
intraoperative
Secondary Outcomes (1)
Change of hemoglobin after surgery
24 hours
Study Arms (2)
dinoprostone 3 mg
EXPERIMENTALpatients will take 1 tablet of vaginal dinoprostone 1 hour before the surgery
placebo
PLACEBO COMPARATORpatients will take 1 tablet of placebo 1 hour before the surgery
Interventions
the patient will take one vaginal tablet of 3 mg dinoprostone 1 hour before surgery
Eligibility Criteria
You may qualify if:
- Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
- Age ≥ 18 years and ≤ 50 years
- Pre-operative hemoglobin \>8 g/dl
- Ability to understand and the willingness to sign a written informed consent.
- Admissible medical/surgical history
- Five or less symptomatic uterine myomas
- All myomas are subserous or intramural.
- Uterine size less than 24 weeks pregnancy
You may not qualify if:
- Patients who have had a prior abdominal myomectomy
- Post-menopausal women
- Patients with known bleeding/clotting disorders
- Patients with a history of gynecologic malignancy
- Hypertension.
- Cardiac and Pulmonary diseases.
- Obesity (body mass index \> 30 kg/m2).
- History of allergic reactions attributed to misoprostol
- Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
AHMED SAMY
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
September 4, 2019
First Posted
September 6, 2019
Study Start
September 10, 2019
Primary Completion
November 30, 2019
Study Completion
December 10, 2019
Last Updated
September 6, 2019
Record last verified: 2019-09