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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03794895
Other study ID # Yasmine's Protocol
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date May 1, 2018

Study information

Verified date January 2019
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in women having IUCD associated menorrhagia


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date May 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Doppler
Doing doppler for women having IUCD associated menorrhagia

Locations

Country Name City State
Egypt AinshamsU Cairo Abbaseya

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 year