Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device
NCT ID: NCT05986344
Last Updated: 2023-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
165 participants
OBSERVATIONAL
2023-08-30
2023-12-30
Brief Summary
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Detailed Description
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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 .
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Copper intrauterine contraceptive device
Women will have the copper T-380 IUD (silverline, imported by DKT Egypt LLC-Egypt) ® IUD.
Copper intrauterine contraceptive device
copper T-380 IUD
Levonorgestrel Intrauterine System
Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD .
LNG-IUS
Levonorgestrel Intrauterine System
Interventions
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Copper intrauterine contraceptive device
copper T-380 IUD
LNG-IUS
Levonorgestrel Intrauterine System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal menstrual bleeding cycles (24-35 days).
Exclusion Criteria
2. Undiagnosed uterine bleeding.
3. Any proven ovarian, uterine or endometrial pathology such as; uterine myoma, adenomyosis, endometrial polyps, ovarian cysts
4. Contraceptive pills had not been taken during the previous 3 months and any previous IUD had been removed at least 1 month earlier
5. Hemorrhagic disorders.
6. Acute or chronic pelvic inflammatory disease
7. Known uterine anomalies e.g., Bicornuate/septate Uterus.
8. Anemia (hemoglobin \<10 g/dl).
9. Diagnosis of active cervical infection
10. Dysplasia in the cervix.
11. Patients wishing post-partum or post-abortum IUD insertion
20 Years
40 Years
FEMALE
Yes
Sponsors
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Beni-Suef University
OTHER
Responsible Party
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Sara Abdallah Mohamed Salem
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Principal Investigators
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Beni-Suef University
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine Beni-Suef University
Locations
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Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, Egypt
Countries
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Central Contacts
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Other Identifiers
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Doppler IUD
Identifier Type: -
Identifier Source: org_study_id
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