Uterine BleedingNCT02705222
Comparison Between D&C and Hysteroscopy in Management of AUB in Perimenopausal Women
A study testing D&C and Hysteroscopy in people with Uterine Bleeding, run by Mohamed Sayed Abdelhafez at 1 site in Egypt.
Trial summary
The aim of this study is to compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding and outlining a mode of treatment-specific to the cause. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Uterine Bleeding
- What is being tested?
- D&C and Hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Mar 2018
- 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 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Perimenopausal women complaining of abnormal uterine bleeding (menorrhagia, metrorrhagia, polymenorrhoea or polymenorrhagia) without local gynecological cause.
- Failure of medical treatment for at least 3 months.
Who cannot join
- Age < 45 or > 55 years.
- Blood disorders or coagulopathy.
- Diagnosed or suspected local gynecologic lesion (polyp, adenomyosis, myoma, malignancy or cervical pathology).
- Use intrauterine contraceptive device.
- Pregnancy related conditions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
About this study
Official title: Comparison Between Dilatation and Curettage and Hysteroscopy in Management of Abnormal Uterine Bleeding in Perimenopausal Women
The aim of this study is to compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding and outlining a mode of treatment-specific to the cause.
Read the detailed description
Perimenopausal women complaining of abnormal uterine bleeding will be selected for assessment through detailed history taking, general and abdominal examination, local gynecological examination, transvaginal sonography (TVS) scanning and routine blood investigations. Eligible participants in our study will be those who complain of menorrhagia, metrorrhagia, polymenorrhoea or polymenorrhagia without local gynecological cause with failure of medical treatment for at least 3 months. All women participating in the study will be randomly allocated into two groups; dilatation and curettage (D\&C) group and hysteroscopy group. For women in the D\&C group, cervical dilatation and fractional endometrial curettage will be done under total intravenous (IV) anesthesia in operation theater and the curetting will be sent for histopathological examination. For women in the hysteroscopy group, hysteroscopy will be done under total IV anesthesia in operation theater hysteroscopic-guided curettings will also be taken and sent for histopathological examination.
- Conditions
- Uterine Bleeding
- Being tested
- D&C, Hysteroscopy
- Keywords
- Abnormal uterine bleeding, Dilatation and curettage, Hysteroscopy
- Medical subject headings
- Uterine Hemorrhage, Metrorrhagia, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D&CProcedure or surgery
Also called Dilatation and curettage
Cervical dilatation and fractional endometrial curettage will be done in operation theatre and the curetting will be sent for histopathological examination
HysteroscopyProcedure or surgery
Hysteroscopy will be done in operation theatre and hysteroscopic-guided curettings will also be taken and sent for histopathological examination
| Study group | Role | What they receive |
|---|---|---|
| D&C group | Active comparator | Women will undergo D\&C Receives: Procedure: D&C |
| Hysteroscopy group | Active comparator | Women will undergo hysteroscopy Receives: Procedure: Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of abnormal endometrial patterns
Number of patients diagnosed to have abnormal endometrial patterns after histopathological examination of the curretings per total number of patients underwent the procedure
Measured: One week after the procedure
Secondary outcomes (1)
Improvement rate
Number of patients improved after performing the procedure and recieving the treatment-specific to cause per total number of patients underwent the procedure
Measured: 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine BleedingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Sayed Abdelhafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Sayed Abdelhafez, Mansoura University
- Investigators
- Sara M Madany, Principal investigator, Mansoura UniversityMohamed S Abdelhafez, Dr, Study director, Mansoura UniversityMoustafa H Nawwar, Dr, Study director, Mansoura UniversityMohamed A Elnegeri, Prof, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705222
- Sponsor's protocol ID
- SMM
- Status last verified
- Oct 2018
- First submitted
- 26 Feb 2016
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dilatation and Curettage and Hysteroscopy in Management of Abnormal Uterine Bleeding in Perimenopausal Women
- ClinicalTrials.gov ID
- NCT02705222
- Acronym / sponsor ID
- SMM
- Conditions
- Uterine Bleeding
- Keywords
- Abnormal uterine bleeding, Dilatation and curettage, Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mohamed Sayed AbdelhafezUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 10 Mar 2016 (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 aim of this study is to compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding and outlining a mode of treatment-specific to the cause.
Detailed description
Perimenopausal women complaining of abnormal uterine bleeding will be selected for assessment through detailed history taking, general and abdominal examination, local gynecological examination, transvaginal sonography (TVS) scanning and routine blood investigations. Eligible participants in our study will be those who complain of menorrhagia, metrorrhagia, polymenorrhoea or polymenorrhagia without local gynecological cause with failure of medical treatment for at least 3 months. All women participating in the study will be randomly allocated into two groups; dilatation and curettage (D\&C) group and hysteroscopy group. For women in the D\&C group, cervical dilatation and fractional endometrial curettage will be done under total intravenous (IV) anesthesia in operation theater and the curetting will be sent for histopathological examination. For women in the hysteroscopy group, hysteroscopy will be done under total IV anesthesia in operation theater hysteroscopic-guided curettings will also be taken and sent for histopathological examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D&C group | Active comparator | Procedure: D&CWomen will undergo D\&C |
| Hysteroscopy group | Active comparator | Procedure: HysteroscopyWomen will undergo hysteroscopy |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Perimenopausal women complaining of abnormal uterine bleeding (menorrhagia, metrorrhagia, polymenorrhoea or polymenorrhagia) without local gynecological cause.
- Failure of medical treatment for at least 3 months.
Key exclusion criteria (5 listed)
- Age < 45 or > 55 years.
- Blood disorders or coagulopathy.
- Diagnosed or suspected local gynecologic lesion (polyp, adenomyosis, myoma, malignancy or cervical pathology).
- Use intrauterine contraceptive device.
- Pregnancy related conditions.
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 |
|---|---|---|
| D&CAlso: Dilatation and curettageCervical dilatation and fractional endometrial curettage will be done in operation theatre and the curetting will be sent for histopathological examination | Procedure or surgery | D&C group |
| HysteroscopyHysteroscopy will be done in operation theatre and hysteroscopic-guided curettings will also be taken and sent for histopathological examination | Procedure or surgery | Hysteroscopy group |
Primary outcome
Percentage of abnormal endometrial patterns
Time frame: One week after the procedure
Number of patients diagnosed to have abnormal endometrial patterns after histopathological examination of the curretings per total number of patients underwent the procedure
1 secondary outcome
Improvement rate
Time frame: 3 months after the procedure
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 29 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Uterine Bleeding
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Active, not recruitingObservational study
Endometrial Cancer Vaginal Fluid Specimen Collection Study
Abnormal Uterine Bleeding (AUB), Endometrial Cancer
Recruiting
Platelet Rich Plasma for Uterine Scar
Cesarean Section Complications, Uterine Bleeding
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.
Sara M Madany principal investigator
Mansoura University
Mohamed S Abdelhafez, Dr study director
Mansoura University
Moustafa H Nawwar, Dr study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D&C and Hysteroscopy in people with Uterine Bleeding, run by Mohamed Sayed Abdelhafez 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 2 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 29 Oct 2018. 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?
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?
Percentage of abnormal endometrial patterns (time frame: One week after the procedure). 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 29 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.