Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal MyomectomyPhase 4NCT02643186
Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
A Phase 4 study testing preoperative vaginal misoprostol and bilateral uterine artery ligation in people with Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The study aims at comparison between the effect of preoperative misoprostol and bilateral uterine artery ligation regarding their effect to decrease blood loss in transabdominal myomectomy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
- What is being tested?
- preoperative vaginal misoprostol and bilateral uterine artery ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2015to Jul 2017
- Phase
- Phase 4
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women in the reproductive age (20-40 years) diagnosed as having uterine fibroids who are consenting to have trans- abdominal myomectomy in the postmenstrual period diagnosed by: clinical symptoms and signs:
- abnormal uterine bleeding (menorrhagia or/and metrorrhagia)
- pain (dull aching lower abdominal pain or dysmenorrhea)
- pressure symptoms (dyspareunia, dysuria, dyschezia or /and backache)
- progressive abdominal enlargement (abdominal swelling) ultrasound (abdominal or transvaginal) to confirm the clinical diagnosis:
- maximum diameter of the largest fibroid is greater than 4 cm
- maximum number of uterine myomas is not to be more than 5 myomas
- uterine fibroid may be subserous or intramural
Who cannot join
- obesity (BMI >30 kg/m2)
- cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10 gm/dl)
- patients known to be allergic to prostaglandin preparations
- patients who received preoperative hormonal therapy (GnRH analogue)
- patients presented by or with suspected malignant gynecological disease patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids patients with contraindication to general anaesthesia
- patients with positive pregnancy test
- virgin patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
walid basuony, lecturer, 0100763042, walidbasuony@gmail.com
About this study
Official title: Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy , a Randomized Control Trail
The study aims at comparison between the effect of preoperative misoprostol and bilateral uterine artery ligation regarding their effect to decrease blood loss in transabdominal myomectomy.
- Being tested
- preoperative vaginal misoprostol, bilateral uterine artery ligation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative vaginal misoprostolDrug
Also called cytotec
preoperative vaginal misoprostol 400 micrograms 1 hour before surgery
bilateral uterine artery ligationProcedure or surgery
Also called devascularization
bilateral ascending uterine artery ligation at the level of uterine isthmus with 2/0 vicryl sutures
| Study group | Role | What they receive |
|---|---|---|
| misoprostol group | Active comparator | preoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy Receives: Drug: preoperative vaginal misoprostol |
| uterine artery ligation group | Active comparator | bilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy Receives: Procedure: bilateral uterine artery ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimated intraoperative blood loss measured in milliliters
Measured: 60 min
Secondary outcomes (6)
the need of intra-operative blood transfusion
Below a hemoglobin concentration of 7 g/dL requiring blood transfusion. It is indicated when intra-operative blood loss exceeds 15% of the patient's estimated blood volume, which is equal to the patient's weight in kilograms multiplied by 10).
Measured: 60 min
the need for conversion from myomectomy to hysterectomy
It is indicated when there is uncontrolled intra-operative hemorrhage affecting the patient's vital signs and not responsive to conservative measures when it is impossible to reconstruct the uterus because of the many defects left by the removal of multiple fibroids
Measured: 60 min
operative time in minutes
Measured: 60 min
intraoperative or postoperative complications
Measured: 24 hours
differance between pre and post operative hemoglobin and hematocrit levels
Measured: 24 hours
duration of hospital stay in days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal MyomectomyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aliaa mohamed ali, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643186
- Sponsor's protocol ID
- ASUMH
- Status last verified
- Dec 2015
- First submitted
- 21 Dec 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy , a Randomized Control Trail
- ClinicalTrials.gov ID
- NCT02643186
- Acronym / sponsor ID
- ASUMH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2017 (estimated)
- First posted
- 31 Dec 2015 (estimated)
- 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.
The study aims at comparison between the effect of preoperative misoprostol and bilateral uterine artery ligation regarding their effect to decrease blood loss in transabdominal myomectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| misoprostol group | Active comparator | Drug: preoperative vaginal misoprostolpreoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy |
| uterine artery ligation group | Active comparator | Procedure: bilateral uterine artery ligationbilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- women in the reproductive age (20-40 years) diagnosed as having uterine fibroids who are consenting to have trans- abdominal myomectomy in the postmenstrual period diagnosed by: clinical symptoms and signs:
- abnormal uterine bleeding (menorrhagia or/and metrorrhagia)
- pain (dull aching lower abdominal pain or dysmenorrhea)
- pressure symptoms (dyspareunia, dysuria, dyschezia or /and backache)
- progressive abdominal enlargement (abdominal swelling) ultrasound (abdominal or transvaginal) to confirm the clinical diagnosis:
Key exclusion criteria (7 listed)
- obesity (BMI >30 kg/m2)
- cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10 gm/dl)
- patients known to be allergic to prostaglandin preparations
- patients who received preoperative hormonal therapy (GnRH analogue)
- patients presented by or with suspected malignant gynecological disease patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids patients with contraindication to general anaesthesia
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 |
|---|---|---|
| preoperative vaginal misoprostolAlso: cytotecpreoperative vaginal misoprostol 400 micrograms 1 hour before surgery | Drug | misoprostol group |
| bilateral uterine artery ligationAlso: devascularizationbilateral ascending uterine artery ligation at the level of uterine isthmus with 2/0 vicryl sutures | Procedure or surgery | uterine artery ligation group |
Primary outcome
estimated intraoperative blood loss measured in milliliters
Time frame: 60 min
6 secondary outcomes
the need of intra-operative blood transfusion
Time frame: 60 min
the need for conversion from myomectomy to hysterectomy
Time frame: 60 min
operative time in minutes
Time frame: 60 min
intraoperative or postoperative complications
Time frame: 24 hours
differance between pre and post operative hemoglobin and hematocrit levels
Time frame: 24 hours
duration of hospital stay in days
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing preoperative vaginal misoprostol and bilateral uterine artery ligation in people with Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy, run by Ain Shams Maternity Hospital 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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Dec 2015. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact walid basuony basuony, lecturer (01001763042, walidbasuony@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimated intraoperative blood loss measured in milliliters (time frame: 60 min). 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 31 Dec 2015.