NCT03130387

Brief Summary

Prevalence of Cesarean Section Niche in women With Unexplained Abnormal Uterine Bleeding

Trial Health

100
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

April 22, 2017

Last Update Submit

April 25, 2017

Conditions

Cesarean Section; DehiscenceAbnormal Uterine Bleeding

Keywords

Hytsteroscopy

Outcome Measures

Primary Outcomes (1)

  • Prevalence of cisarean section niche

    Prevalence of cisarean section niche in women complainig of unexplained abnormal uterine bleeding

    1 year

Study Arms (1)

Office hysteroscopy

OTHER

Examinatin with Office hysteroscope for women with abnormal uterine bleeding who had a history of previous cesarean section

Device: Office Hysteroscope

Interventions

Office HysteroscopeDEVICE

Diagnosis of C.S niche in patients wit AUB by office hysteroscope

Office hysteroscopy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales only
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with a history of cesarean section who are complaining of abnormal uterine bleeding with the following criteria :
  • Normal complete blood count apart from paramaters of anemia
  • Not using drugs affecting coagulation profile
  • Bleeding is not related to pregnancy
  • Not using intrauterine contraceptive devices or hormonal contraceptives
  • By ultrasonography : no abnormalities in the pelvis e.g benign or malignant tumors , ovarian cysts or tumors
  • No evidence of cervical abnormalities as cause of bleeding with cervical examination or cervical smears

You may not qualify if:

  • If the patient refused the technique ( office hysteroscopy )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Hysteroscopic examination for patients with AUB
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Early Cancer Detection Unit

Study Record Dates

First Submitted

April 22, 2017

First Posted

April 26, 2017

Study Start

January 1, 2016

Primary Completion

April 20, 2017

Study Completion

April 20, 2017

Last Updated

April 26, 2017

Record last verified: 2017-04