NCT03205111

Brief Summary

The aim of this study is to photographically characterize the endometrium in patients presenting with abnormal uterine bleeding at age group from 20 to 45 years old. and compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

June 29, 2017

Last Update Submit

June 29, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hysteroscopic assessment of endometrial pathology

    Patterns of endometrial pathology after histopathological examination of the curretings in patients with abnormal uterine bleeding

    7 days

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

100 women between 20 and 45 years of age who presented with complaints of abnormal uterine bleeding will be recruited for this study.

You may qualify if:

  • Perimenopausal women complaining of abnormal uterine bleeding.

You may not qualify if:

  • Active pelvic infections
  • Medical disorders
  • Bleeding tendency
  • Hormonal treatment
  • Pregnancy
  • Contraceptive treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Bennett AR, Gray SH. What to do when she's bleeding through: the recognition, evaluation, and management of abnormal uterine bleeding in adolescents. Curr Opin Pediatr. 2014 Aug;26(4):413-9. doi: 10.1097/MOP.0000000000000121.

  • Saadia A, Mubarik A, Zubair A, Jamal S, Zafar A. Diagnostic accuracy of endometrial curettage in endometrial pathology. J Ayub Med Coll Abbottabad. 2011 Jan-Mar;23(1):129-31.

  • Zhu HL, Liang XD, Wang JL, Cui H, Wei LH. Hysteroscopy and directed biopsy in the diagnosis of endometrial carcinoma. Chin Med J (Engl). 2010 Dec;123(24):3524-8.

MeSH Terms

Conditions

Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed Z. Fahmi

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Essam M. Abdallah, Profosser

    Assiut University

    STUDY CHAIR
  • Hazem S. Mohammed, Professor

    Assiut University

    STUDY DIRECTOR
  • Kamal M. Zahran, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 2, 2017

Study Start

July 1, 2017

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share