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To evaluate the correlation between uterine artery Doppler indices and subsequent menstrual changes after 3 months of insertion of copper T-380 IUD and LNG-IUS
A randomized prospective clinical trial
Study Population:
The study population includes multiparous women, having normal menstrual cycles, who are eligible for insertion of IUCD. Women will be recruited for enrollment when they come to the family planning clinic. They will be counseled about different contraceptive options. If they want to have the IUCD, they will be asked to participate in the study after been evaluated to ensure fulfilling inclusion and exclusion criteria Women will be enrolled in the study after giving written informed consent Group (A): ….Women will have the copper T-380 IUD (PREGNA, India, imported by DKT Egypt LLC-Egypt) ® IUD.
Group (B): …. Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Copper intrauterine contraceptive device | Women will have the copper T-380 IUD (silverline, imported by DKT Egypt LLC-Egypt) ® IUD. |
| |
| Levonorgestrel Intrauterine System | Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copper intrauterine contraceptive device | Device | copper T-380 IUD |
|
| Measure | Description | Time Frame |
|---|---|---|
| menstrual changes. | Pictorial blood loss assessment chart PBAC score (a score >100was equivalent to blood loss >80 mL) | 3 months after insertion |
| uterine artery pulsatility index | trans-vaginal ultrasound pulsed doppler | 3 months after insertion |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes multiparous women, having normal menstrual cycles, who are eligible for insertion of IUCD. Women will be recruited for enrollment when they come to the family planning clinic. They will be counseled about different contraceptive options. If they want to have the IUCD, they will be asked to participate in the study after been evaluated to ensure fulfilling inclusion and exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara A Salem, MD | Contact | 01272842226 | 02 | sara_abdallah100@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Beni-Suef University | Faculty of Medicine Beni-Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-suef university Hospital | Banī Suwayf | Beni Suweif Governorate | 62521 | Egypt |
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| LNG-IUS | Device | Levonorgestrel Intrauterine System |
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