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Completed

NCT Number: NCT02705222

Comparison Between D&C and Hysteroscopy in Management of AUB 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.

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Key information

Conditions

Uterine Bleeding Dilatation, Pathologic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Metrorrhagia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

D&C

Procedure

Cervical dilatation and fractional endometrial curettage will be done in operation theatre and the curetting will be sent for histopathological examination

Other names: Dilatation and curettage

Hysteroscopy

Procedure

Hysteroscopy will be done in operation theatre and hysteroscopic-guided curettings will also be taken and sent for histopathological examination

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mohamed Sayed Abdelhafez

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 10, 2016
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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