Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device

Beni-Suef University165 enrolled

Overview

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 .

Study Type

OBSERVATIONAL

Enrollment

165

Conditions

Intrauterine Contraceptive Device Complication

Interventions

Copper intrauterine contraceptive deviceDEVICE

copper T-380 IUD

LNG-IUSDEVICE

Levonorgestrel Intrauterine System

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Outcomes

Primary Outcomes

menstrual changes.

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

Time frame: 3 months after insertion

uterine artery pulsatility index

trans-vaginal ultrasound pulsed doppler

Time frame: 3 months after insertion

Central Contacts

Sara A Salem, MD

CONTACT

01272842226 sara_abdallah100@yahoo.com

Data from ClinicalTrials.gov

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