Prediction of Response to IUCD Associated Menorrhagia Using Doppler

Women's Health: Amenorrhea/Dysmenorrhea Clinical Trial

Official title:

Assessment of Efficacy of Uterine Artery Doppler in Predicting the Response to Mefenamic Acid During Treatment of Women With IUCD Associated Menorrhagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794895
• Other study ID #: Yasmine's Protocol
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Amenorrhea
• Dysmenorrhea
• Menorrhagia
• Women's Health: Amenorrhea/Dysmenorrhea

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