Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device

Beni-Suef University

Status: Not yet enrolling

Conditions: Intrauterine Contraceptive Device Complication

Treatments: Device: Copper intrauterine contraceptive device; Device: LNG-IUS

Study type: Observational

Funder types: Other

Identifiers

NCT05986344

Doppler IUD

Details and patient eligibility

About

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

Full 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 .

Enrollment: 165 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

165 participants in 2 patient groups

Copper intrauterine contraceptive device

Description:

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

Treatment:

Device: Copper intrauterine contraceptive device

Levonorgestrel Intrauterine System

Description:

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

Treatment:

Device: LNG-IUS