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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02705222
Other study ID # SMM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date March 2018

Study information

Verified date October 2018
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 55 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
D&C
Cervical dilatation and fractional endometrial curettage will be done in operation theatre and the curetting will be sent for histopathological examination
Hysteroscopy
Hysteroscopy will be done in operation theatre and hysteroscopic-guided curettings will also be taken and sent for histopathological examination

Locations

Country Name City State
Egypt Obstetrics and Gynecology Department in Mansoura University Hospital Mansourah Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mohamed Sayed Abdelhafez

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 One week after the procedure
Secondary 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 3 months after the procedure
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