Prediction of Response to IUCD Associated Menorrhagia Using Doppler

NCT03794895 | Completed

• 1 other identifier: Yasmine's Protocol
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Women's Health: Amenorrhea/Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single arm clinical trial

EXPERIMENTAL

Device: Doppler

Interventions

Doppler DEVICE

Doing doppler for women having IUCD associated menorrhagia

Single arm clinical trial

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: female having menorrhagia due to IUCD
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinshamsU

Cairo, Abbaseya, 11511, Egypt

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Echocardiography, Doppler

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Ultrasonography, Doppler; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Yasmine Es Ismail, Bachelor

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 7, 2019
• Study Start: May 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Locations

EG (1)