Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device

Not yet recruiting

• Conditions: Intrauterine Contraceptive Device Complication
• Interventions: Device: Copper intrauterine contraceptive device; Device: LNG-IUS

• Registration Number: NCT05986344
• Lead Sponsor: Beni-Suef University

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

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 Timeline

• Study First Submitted: 2023-07-25
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-13
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-15
• Study Start: 2023-08-30
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 165

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Copper intrauterine contraceptive device	Copper intrauterine contraceptive device	Women will have the copper T-380 IUD (silverline, imported by DKT Egypt LLC-Egypt) ® IUD.
Levonorgestrel Intrauterine System	LNG-IUS	Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD .

Primary Outcome Measures

Name	Time	Method
menstrual changes.	3 months after insertion	Pictorial blood loss assessment chart PBAC score (a score \>100was equivalent to blood loss \>80 mL)
uterine artery pulsatility index	3 months after insertion	trans-vaginal ultrasound pulsed doppler

Trial Locations

Locations (1)

Beni-suef university Hospital; 🇪🇬 Banī Suwayf, Beni Suef, Egypt