Comparison Between D&C and Hysteroscopy in Management of AUB in Perimenopausal Women

Uterine Bleeding Clinical Trial

Official title:

Comparison Between Dilatation and Curettage and Hysteroscopy in Management of Abnormal Uterine Bleeding in Perimenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705222
• Other study ID #: SMM
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hemorrhage
• Uterine Bleeding
• Uterine Hemorrhage

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