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Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device

Sponsor
Beni-Suef University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05986344
Collaborator
(none)
165
Enrollment
1
Location
4
Anticipated Duration (Months)
41.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Copper intrauterine contraceptive device
  • Device: LNG-IUS

Detailed Description

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 .

Study Design

Study Type:
Observational
Anticipated Enrollment :
165 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Correlation Between Uterine Artery Doppler Indices and Menstrual Changes After Insertion of Copper Intrauterine Contraceptive Device and Levonorgestrel Intrauterine System
Anticipated Study Start Date :
Aug 30, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Copper intrauterine contraceptive device

Women will have the copper T-380 IUD (silverline, imported by DKT Egypt LLC-Egypt) ® IUD.

Device: Copper intrauterine contraceptive device
copper T-380 IUD
Other Names:
  • silverline

    		•
    Levonorgestrel Intrauterine System

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

    Device: LNG-IUS
    Levonorgestrel Intrauterine System
    Other Names:
  • mirena

    		•

    Outcome Measures

    Primary Outcome Measures

    1. menstrual changes. [3 months after insertion]

      Pictorial blood loss assessment chart PBAC score (a score >100was equivalent to blood loss >80 mL)

    2. uterine artery pulsatility index [3 months after insertion]

      trans-vaginal ultrasound pulsed doppler

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni-suef university Hospital Banī Suwayf Beni Suef Egypt 62521

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

    • Principal Investigator: Beni-Suef University, Faculty of Medicine Beni-Suef University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Abdallah Mohamed Salem, principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT05986344
    Other Study ID Numbers:
    • Doppler IUD
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 15, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sara Abdallah Mohamed Salem, principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University
    Intrauterine Contraceptive Device
    Doppler
    Additional relevant MeSH terms:
    Copper
    Contraceptive Agents

    Study Results

    No Results Posted as of Aug 15, 2023