Cesarean Section; DehiscenceNicheNCT03130387
Prevalence of Cesarean Section Niche in Women With Unexplained Abnormal Uterine Bleeding
A study testing Office Hysteroscope in people with Cesarean Section; Dehiscence and Abnormal Uterine Bleeding, run by Ain Shams University.
Trial summary
Prevalence of Cesarean Section Niche in women With Unexplained Abnormal Uterine Bleeding Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section; Dehiscence, Abnormal Uterine Bleeding
- What is being tested?
- Office Hysteroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 20 Apr 2017
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a history of cesarean section who are complaining of abnormal uterine bleeding with the following criteria :
- Normal complete blood count apart from paramaters of anemia
- Not using drugs affecting coagulation profile
- Bleeding is not related to pregnancy
- Not using intrauterine contraceptive devices or hormonal contraceptives
- By ultrasonography : no abnormalities in the pelvis e.g benign or malignant tumors , ovarian cysts or tumors
- No evidence of cervical abnormalities as cause of bleeding with cervical examination or cervical smears
Who cannot join
- Any patient not fulfilling the inclusion criteria
- If the patient refused the technique ( office hysteroscopy )
About this study
Prevalence of Cesarean Section Niche in women With Unexplained Abnormal Uterine Bleeding
Read the detailed description
Prevalence of Cesarean Section Niche as diagnosed by office hysteroscopy and transvaginal sonography in women With Unexplained Abnormal Uterine Bleeding
- Being tested
- Office Hysteroscope
- Keywords
- Hytsteroscopy
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office HysteroscopeDevice
Diagnosis of C.S niche in patients wit AUB by office hysteroscope
| Study group | Role | What they receive |
|---|---|---|
| Office hysteroscopy | Other | Examinatin with Office hysteroscope for women with abnormal uterine bleeding who had a history of previous cesarean section Receives: Device: Office Hysteroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cisarean section niche
Prevalence of cisarean section niche in women complainig of unexplained abnormal uterine bleeding
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Jan 2016
- Primary completion20 Apr 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section; DehiscenceStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Hysteroscopic examination for patients with AUB
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Hassan Elbohoty, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130387
- Sponsor's protocol ID
- IEldawa
- Acronym
- Niche
- Status last verified
- Apr 2017
- First submitted
- 22 Apr 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cesarean Section Niche in Women With Unexplained Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT03130387
- Acronym / sponsor ID
- Niche / IEldawa
- Keywords
- Hytsteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 26 Apr 2017 (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.
Prevalence of Cesarean Section Niche in women With Unexplained Abnormal Uterine Bleeding
Detailed description
Prevalence of Cesarean Section Niche as diagnosed by office hysteroscopy and transvaginal sonography in women With Unexplained Abnormal Uterine Bleeding
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hysteroscopic examination for patients with AUB
| Arm | Type | Receives |
|---|---|---|
| Office hysteroscopy | Other | Device: Office HysteroscopeExaminatin with Office hysteroscope for women with abnormal uterine bleeding who had a history of previous cesarean section |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with a history of cesarean section who are complaining of abnormal uterine bleeding with the following criteria :
- Normal complete blood count apart from paramaters of anemia
- Not using drugs affecting coagulation profile
- Bleeding is not related to pregnancy
- Not using intrauterine contraceptive devices or hormonal contraceptives
Key exclusion criteria (2 listed)
- Any patient not fulfilling the inclusion criteria
- If the patient refused the technique ( office hysteroscopy )
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 |
|---|---|---|
| Office HysteroscopeDiagnosis of C.S niche in patients wit AUB by office hysteroscope | Device | Office hysteroscopy |
Primary outcome
Prevalence of cisarean section niche
Time frame: 1 year
Prevalence of cisarean section niche in women complainig of unexplained abnormal uterine bleeding
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 26 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Office Hysteroscope in people with Cesarean Section; Dehiscence and Abnormal Uterine Bleeding, run by Ain Shams University.
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 7 inclusion and 2 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Prevalence of cisarean section niche (time frame: 1 year). 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 26 Apr 2017.