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

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ClinicalTrials.gov Identifier: NCT02705222
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Sayed Abdelhafez, Mansoura University

Brief 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.

Condition or disease Intervention/treatment Phase
Uterine Bleeding Procedure: D&C Procedure: Hysteroscopy Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison Between Dilatation and Curettage and Hysteroscopy in Management of Abnormal Uterine Bleeding in Perimenopausal Women
Actual Study Start Date : March 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

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Arm Intervention/treatment
Active Comparator: D&C group
Women will undergo D&C
Procedure: D&C
Cervical dilatation and fractional endometrial curettage will be done in operation theatre and the curetting will be sent for histopathological examination
Other Name: Dilatation and curettage

Active Comparator: Hysteroscopy group
Women will undergo hysteroscopy
Procedure: Hysteroscopy
Hysteroscopy will be done in operation theatre and hysteroscopic-guided curettings will also be taken and sent for histopathological examination




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Improvement rate [ Time Frame: 3 months after the procedure ]
    Number of patients improved after performing the procedure and recieving the treatment-specific to cause per total number of patients underwent the procedure



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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705222


Locations
Egypt
Obstetrics and Gynecology Department in Mansoura University Hospital
Mansourah, Dakahlia, Egypt, 35111
Sponsors and Collaborators
Mohamed Sayed Abdelhafez
Investigators
Principal Investigator: Sara M Madany Mansoura University
Study Director: Mohamed S Abdelhafez, Dr Mansoura University
Study Director: Moustafa H Nawwar, Dr Mansoura University
Study Chair: Mohamed A Elnegeri, Prof Mansoura University

Responsible Party: Mohamed Sayed Abdelhafez, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02705222     History of Changes
Other Study ID Numbers: SMM
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mohamed Sayed Abdelhafez, Mansoura University:
Abnormal uterine bleeding
Dilatation and curettage
Hysteroscopy

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female