Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device

Study Overview
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Brief Summary
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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

Detailed Description
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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 .

Official Title
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Correlation Between Uterine Artery Doppler Indices and Menstrual Changes After Insertion of Copper Intrauterine Contraceptive Device and Levonorgestrel Intrauterine System

Conditions
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Intrauterine Contraceptive Device Complication

Intervention / Treatment
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* Device: Copper intrauterine contraceptive device
* Device: LNG-IUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Desire to have intrauterine contraceptive device after counseling about different contraceptive options and consented to the study. Normal menstrual bleeding cycles (24-35 days). Exclusion Criteria: Nulliparity. Undiagnosed uterine bleeding. Any proven ovarian, uterine or endometrial pathology such as; uterine myoma, adenomyosis, endometrial polyps, ovarian cysts Contraceptive pills had not been taken during the previous 3 months and any previous IUD had been removed at least 1 month earlier Hemorrhagic disorders. Acute or chronic pelvic inflammatory disease Known uterine anomalies e.g., Bicornuate/septate Uterus. Anemia (hemoglobin <10 g/dl). Diagnosis of active cervical infection Dysplasia in the cervix. Patients wishing post-partum or post-abortum IUD insertion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Copper intrauterine contraceptive device<br>Women will have the copper T-380 IUD (silverline, imported by DKT Egypt LLC-Egypt) ® IUD. | Device: Copper intrauterine contraceptive device<br>* copper T-380 IUD<br>* Other names: silverline;|
| Levonorgestrel Intrauterine System<br>Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD . | Device: LNG-IUS<br>* Levonorgestrel Intrauterine System<br>* Other names: mirena;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine Contraceptive Device, Doppler