Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device

NCT ID: NCT05986344

Last Updated: 2023-08-15

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-30

Study Completion Date

2023-12-30

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 .

Conditions

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Intrauterine Contraceptive Device Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DEVICE

copper T-380 IUD

Levonorgestrel Intrauterine System

Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD .

LNG-IUS

Intervention Type DEVICE

Levonorgestrel Intrauterine System

Interventions

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Copper intrauterine contraceptive device

copper T-380 IUD

Intervention Type DEVICE

LNG-IUS

Levonorgestrel Intrauterine System

Intervention Type DEVICE

Other Intervention Names

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silverline mirena

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

1. Nulliparity.
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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Sara Abdallah Mohamed Salem

principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Egypt

Central Contacts

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Sara A Salem, MD

Role: CONTACT

01272842226 ext. 02

Other Identifiers

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Doppler IUD

Identifier Type: -

Identifier Source: org_study_id

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