Back to resultsPrediction of Response to IUCD Associated Menorrhagia Using Doppler
Primary Purpose
Women's Health: Amenorrhea/Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Doppler
Sponsored by
About this trial
This is an interventional screening trial for Women's Health: Amenorrhea/Dysmenorrhea
Eligibility Criteria
Inclusion Criteria:
- women in chile bearing period (age 20-35 yrs ) with history of regular menstrual cycle presenting with recent onset of more then three months menorrhagia after IUCD "copper T 380 A" insertion
Exclusion Criteria:
- history of bleeding tendency
- history of abnormal uterine bleeding due to other causes
- history of active liver disease
- history of antiplatelet or anticoagulant intake in the last month
- history of thyroid disease
- history of endometritis
- history of allergy to NSAIDs
- Adenomyosis
- women having contraindications to use NSAIDs e.g. peptic ulcer
- Insulin dependant diabetes mellitus
Sites / Locations
- AinshamsU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm clinical trial
Arm Description
Outcomes
Primary Outcome Measures
Resistance index and Pulsitality index (Predicting the response to IUCD associated menorrhagia)
Base line uterine artery doppler is done to the patient complaining of IUCD related menorrhagia prior to treatment , parameters of doppler are: resistance index and pulsitality index, then the patient takes mefenamic acid tablets 500 mg three times daily for five days, assessment of response whether the patient is responder or not is done using pictorial blood loss assessment chart then base line doppler parameters in responders and non responders are compared to correlate the response to base line doppler parameters
Secondary Outcome Measures
Full Information
NCT ID
NCT03794895
First Posted
December 27, 2018
Last Updated
January 3, 2019
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT03794895
Brief Title
Prediction of Response to IUCD Associated Menorrhagia Using Doppler
Official Title
Assessment of Efficacy of Uterine Artery Doppler in Predicting the Response to Mefenamic Acid During Treatment of Women With IUCD Associated Menorrhagia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in women having IUCD associated menorrhagia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women's Health: Amenorrhea/Dysmenorrhea
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm clinical trial
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Doppler
Intervention Description
Doing doppler for women having IUCD associated menorrhagia
Primary Outcome Measure Information:
Title
Resistance index and Pulsitality index (Predicting the response to IUCD associated menorrhagia)
Description
Base line uterine artery doppler is done to the patient complaining of IUCD related menorrhagia prior to treatment , parameters of doppler are: resistance index and pulsitality index, then the patient takes mefenamic acid tablets 500 mg three times daily for five days, assessment of response whether the patient is responder or not is done using pictorial blood loss assessment chart then base line doppler parameters in responders and non responders are compared to correlate the response to base line doppler parameters
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female having menorrhagia due to IUCD
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women in chile bearing period (age 20-35 yrs ) with history of regular menstrual cycle presenting with recent onset of more then three months menorrhagia after IUCD "copper T 380 A" insertion
Exclusion Criteria:
history of bleeding tendency
history of abnormal uterine bleeding due to other causes
history of active liver disease
history of antiplatelet or anticoagulant intake in the last month
history of thyroid disease
history of endometritis
history of allergy to NSAIDs
Adenomyosis
women having contraindications to use NSAIDs e.g. peptic ulcer
Insulin dependant diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasmine Es Ismail, Bachelor
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AinshamsU
City
Cairo
State/Province
Abbaseya
ZIP/Postal Code
11511
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Prediction of Response to IUCD Associated Menorrhagia Using Doppler
We'll reach out to this number within 24 hrs