HysterectomyPhase 3NCT04080323
Single-dose Vaginal Dinoprostone and Hysterectomy
A Phase 3 study testing Dinoprostone 3 mg in people with Hysterectomy, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Dinoprostone 3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2019to 30 Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Single Preoperative Dose of Vaginal Dinoprostone on Intraoperative Blood Loss During Abdominal Hysterectomy:a Randomized Controlled Trial
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
- Conditions
- Hysterectomy
- Being tested
- Dinoprostone 3 mg, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinoprostone 3 mgDrug
1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery
placeboDrug
1 vaginal tablet of placebo 60 minutes before surgery
| Study group | Role | What they receive |
|---|---|---|
| dinoprostone 3 mg | Experimental | 60 minutes before the surgery 3 mg of dinoprostone inserted vaginally Receives: Drug: Dinoprostone 3 mg |
| placebo | Placebo comparator | 60 minutes before the surgery 1 tablet of placebo inserted vaginally Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease blood loss during hysterectomy
decrease blood loss during hysterectomy in ml
Measured: intraoperative
Secondary outcomes (1)
postoperative hemoglobin level
postoperative hemoglobin level in gm/dl
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start25 Sep 2019
- Primary completion30 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, Study director, Cairo Universityayman taher, MD, Principal investigator, Cairo Universityahmed S Ali, Principal investigator, faculty of medicine al-azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080323
- Sponsor's protocol ID
- dinoprostone hysterectomy
- Status last verified
- Aug 2020
- First submitted
- 4 Sep 2019
- Last updated
- 27 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Preoperative Dose of Vaginal Dinoprostone on Intraoperative Blood Loss During Abdominal Hysterectomy:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04080323
- Acronym / sponsor ID
- dinoprostone hysterectomy
- Conditions
- Hysterectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dinoprostone 3 mg | Experimental | Drug: Dinoprostone 3 mg60 minutes before the surgery 3 mg of dinoprostone inserted vaginally |
| placebo | Placebo comparator | Drug: placebo60 minutes before the surgery 1 tablet of placebo inserted vaginally |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients presenting for hysterectomy for any benign indication including uterine fibroids.
Key exclusion criteria (5 listed)
- • Patients with known or suspected endometrial/ovarian/cervical cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dinoprostone 3 mg1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery | Drug | dinoprostone 3 mg |
| placebo1 vaginal tablet of placebo 60 minutes before surgery | Drug | placebo |
Primary outcome
decrease blood loss during hysterectomy
Time frame: intraoperative
decrease blood loss during hysterectomy in ml
1 secondary outcome
postoperative hemoglobin level
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMED SAMY study director
Cairo University
ayman taher, MD principal investigator
Cairo University
ahmed S Ali principal investigator
faculty of medicine al-azhar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dinoprostone 3 mg in people with Hysterectomy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease blood loss during hysterectomy (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.