Single-dose Vaginal Dinoprostone and Hysterectomy
Effect of a Single Preoperative Dose of Vaginal Dinoprostone on Intraoperative Blood Loss During Abdominal Hysterectomy:a Randomized Controlled Trial
1 other identifier
interventional
118
1 country
1
Brief Summary
In this study, we will assess the efficacy of dinoprostone in minimizing blood loss during hysterectomy when used as a single preoperative dose via the vaginal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect
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
1 active site
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 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedAugust 27, 2020
August 1, 2020
8 months
September 4, 2019
August 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
decrease blood loss during hysterectomy
decrease blood loss during hysterectomy in ml
intraoperative
Secondary Outcomes (1)
postoperative hemoglobin level
24 hours
Study Arms (2)
dinoprostone 3 mg
EXPERIMENTAL60 minutes before the surgery 3 mg of dinoprostone inserted vaginally
placebo
PLACEBO COMPARATOR60 minutes before the surgery 1 tablet of placebo inserted vaginally
Interventions
1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery
Eligibility Criteria
You may qualify if:
- Patients presenting for hysterectomy for any benign indication including uterine fibroids.
- Age ≥ 18 years
- Pre-operative hemoglobin \>8 g/dl
- Willing to have dinoprostone or a placebo prior to hysterectomy
- Ability to understand and the willingness to sign a written informed consent.
You may not qualify if:
- Patients with known or suspected endometrial/ovarian/cervical cancer.
- Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia.
- Patients currently undergoing treatment for any type of cancer.
- Patients with known bleeding/clotting disorders or a history of thromboembolism (including deep venous thrombosis or pulmonary embolism)
- History of allergic reactions to dinoprostone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Ahmed Samy
Giza, 11231, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AHMED SAMY
Cairo University
- PRINCIPAL INVESTIGATOR
ayman taher, MD
Cairo University
- PRINCIPAL INVESTIGATOR
ahmed S Ali
faculty of medicine al-azhar university
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 25, 2019
Primary Completion
May 30, 2020
Study Completion
June 30, 2020
Last Updated
August 27, 2020
Record last verified: 2020-08