Contraception
Conditions
Brief summary
The Copper intrauterine device is the most common method of reversible contraception worldwide. Abnormal uterine bleeding and pain are the most common medical indications for the discontinuation of the intrauterine device. Excessive prostaglandin release in the endometrial cavity appears to play an important role in both bleeding and pain related to copper intrauterine devices.There are many types of prostaglandin metabolites that present in the endometrium one of them is prostacyclin which causes vasodilatation and inhibits platelet aggregation. Another one is thromboxane which has two types; A2 which is active and rapidly converted into B2, which is inactive. Thromboxane causes vasoconstriction and blood clotting. Non-steroidal anti-inflammatory drugs (NSAIDs) are prostaglandin synthetase inhibitors acting by decreasing production of endometrial prostaglandins; they can improve both heavy uterine bleeding and pain. Since its discovery; several drugs in NSAIDs class have been used to treat heavy uterine bleeding and pain associated with copper intrauterine device use such as mefenamic acid, ibuprofen and naproxen. The most recent systematic review found NSAIDs is the most widely studied drugs for reduction of the menstrual blood and pain associated with copper intrauterine device. The Cochrane Review also found that NSAIDs are the most effective treatment to reduce the bleeding with copper intrauterine device use.
Interventions
DRUGIbuprofen
The women will receive 400mg ibuprofen 3 times per day from the first day of the cycle for 5 days
Sponsors
Assiut University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Women have menorrhagia secondary to IUD. 2. Planning for birth spacing for at least 1 year. 3. Patient aged between 20-45 years old. 4. No history of any medical treatment. 5. Living in a nearby area to make follow-up reasonably possible.
Exclusion criteria
1. Evidence of defective coagulation. 2. History or evidence of malignancy. 3. Hyperplasia in the endometrial biopsy. 4. Incidental adnexal abnormality on ultrasound. 5. Untreated abnormal cervical cytology 6. contraindications to ibuprofen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of bleeding days per month | 3 months | by menstrual diary |
Secondary
| Measure | Time frame |
|---|---|
| Uterine Doppler indices | 3 months |
Countries
Egypt
Outcome results
None listed