GYN DisordersNCT03675802
Cervical Preparation in Hysteroscopy
A study testing misoprostol and dinoprostone in people with GYN Disorders, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
The hysteroscopy was performed in the proliferativephase of the menstrual cycle. The patients were given generalintravenous anesthesia (propofol/fentanyl) after the vulvar and the vaginal area had been disinfected with a 7.5% Betadinesolution by the surgical nurse All operations were performed by the same surgeon to… Read more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- GYN Disorders
- What is being tested?
- misoprostol and dinoprostone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Sep 2018to 15 Mar 2019
- Phase
- Interventional
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients of reproductive age
- have undergone a cesarean section at least once
- an indication for diagnostic hysteroscopy for menstrualproblems or suspected intrauterine lesions (suchas uterine polyps and filling defects in the uterine cavity) by abnormal findings from hysterosalpingography,ultrasonography, or saline infusion sonography.
Who cannot join
- Patients who delivered vaginally
- Had undergone any other transcervical or transabdominal uterine and cervical intervention other than cesareansection, such as loop electrosurgical procedures, cervical cryotherapy, cervical biopsies, and spontaneousabortions, previous dilation, and previous electiveabortions.
- Patients with cervical pathology,e.g. tears or polyps.
- The patients with a contraindicationto prostaglandins such as hypersensitivity, bronchial asthma, glaucoma, severeasthma, cardiac, liver or kidney diseases.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Randomized Comparison of Vaginal Dinoprostone and Misoprostol for Cervical Ripening Before Diagnostic Hysteroscopy in Patients Who Have Undergone Cesarean Section
The hysteroscopy was performed in the proliferativephase of the menstrual cycle.
The patients were given generalintravenous anesthesia (propofol/fentanyl) after the vulvar and the vaginal area had been disinfected with a 7.5% Betadinesolution by the surgical nurse All operations were performed by the same surgeon to avoid possible discrepancies between different surgeons.
Read the detailed description
Astandard rigid30 hysteroscope (Karl Storz bettocchi hysteroscope) with a 30° viewing angleand an outer sheath diameter 5.5 mm, inner sheath diameter 4.3 mm and scope diameter 2.9 mmwas used in all procedures.
A speculum was introduced into the vagina, and the uterine cervixwas visualized. Initially, the surgeon attempted to passthrough the cervical canal with the tool directly. When thatwas not possible or when the cervical canal was too rigid ortoo tight, the cervix was grasped with a tenaculum.
- Conditions
- GYN Disorders
- Being tested
- misoprostol, dinoprostone
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostolDrug
giving misoprostol to this group
dinoprostoneDrug
giving dinoprostine
| Study group | Role | What they receive |
|---|---|---|
| Arm number one ,misoprostol | Active comparator | Not described Receives: Drug: misoprostol |
| Arm number 2 dinoprostone | Active comparator | Not described Receives: Drug: dinoprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who will require cervical dilatation
Measured: within an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start23 Sep 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion15 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GYN DisordersStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
- Investigators
- mahmoud Alalfy, PhD, Study chair, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675802
- Sponsor's protocol ID
- Hysteroscopy
- Status last verified
- Jan 2019
- First submitted
- 16 Sep 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Vaginal Dinoprostone and Misoprostol for Cervical Ripening Before Diagnostic Hysteroscopy in Patients Who Have Undergone Cesarean Section
- ClinicalTrials.gov ID
- NCT03675802
- Acronym / sponsor ID
- Hysteroscopy
- Conditions
- GYN Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 23 Sep 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 15 Mar 2019 (estimated)
- First posted
- 18 Sep 2018 (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.
The hysteroscopy was performed in the proliferativephase of the menstrual cycle.
The patients were given generalintravenous anesthesia (propofol/fentanyl) after the vulvar and the vaginal area had been disinfected with a 7.5% Betadinesolution by the surgical nurse All operations were performed by the same surgeon to avoid possible discrepancies between different surgeons.
Detailed description
Astandard rigid30 hysteroscope (Karl Storz bettocchi hysteroscope) with a 30° viewing angleand an outer sheath diameter 5.5 mm, inner sheath diameter 4.3 mm and scope diameter 2.9 mmwas used in all procedures.
A speculum was introduced into the vagina, and the uterine cervixwas visualized. Initially, the surgeon attempted to passthrough the cervical canal with the tool directly. When thatwas not possible or when the cervical canal was too rigid ortoo tight, the cervix was grasped with a tenaculum.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm number one ,misoprostol | Active comparator | Drug: misoprostol |
| Arm number 2 dinoprostone | Active comparator | Drug: dinoprostone |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients of reproductive age
- have undergone a cesarean section at least once
- an indication for diagnostic hysteroscopy for menstrualproblems or suspected intrauterine lesions (suchas uterine polyps and filling defects in the uterine cavity) by abnormal findings from hysterosalpingography,ultrasonography, or saline infusion sonography.
Key exclusion criteria (5 listed)
- Patients who delivered vaginally
- Had undergone any other transcervical or transabdominal uterine and cervical intervention other than cesareansection, such as loop electrosurgical procedures, cervical cryotherapy, cervical biopsies, and spontaneousabortions, previous dilation, and previous electiveabortions.
- Patients with cervical pathology,e.g. tears or polyps.
- The patients with a contraindicationto prostaglandins such as hypersensitivity, bronchial asthma, glaucoma, severeasthma, cardiac, liver or kidney diseases.
- -
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 |
|---|---|---|
| misoprostolgiving misoprostol to this group | Drug | Arm number one ,misoprostol |
| dinoprostonegiving dinoprostine | Drug | Arm number 2 dinoprostone |
Primary outcome
The number of women who will require cervical dilatation
Time frame: within an hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No
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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.
mahmoud Alalfy, PhD study chair
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing misoprostol and dinoprostone in people with GYN Disorders, run by Aljazeera 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 3 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: status not confirmed, as of the sponsor's last update on 9 Jan 2019. 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.
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 Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of women who will require cervical dilatation (time frame: within an hour). 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 9 Jan 2019.