Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device

NCT05986344 | Unknown

• 1 other identifier: Doppler IUD
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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

Conditions

Intrauterine Contraceptive Device Complication

Keywords

Intrauterine Contraceptive Device; Doppler

Outcome Measures

Primary Outcomes (2)

• menstrual changes.

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

  3 months after insertion

• uterine artery pulsatility index

  trans-vaginal ultrasound pulsed doppler

  3 months after insertion

Study Arms (2)

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

Levonorgestrel Intrauterine System

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

Device: LNG-IUS

Interventions

Copper intrauterine contraceptive device DEVICE

copper T-380 IUD

Also known as: silverline

Copper intrauterine contraceptive device

LNG-IUS DEVICE

Levonorgestrel Intrauterine System

Also known as: mirena

Levonorgestrel Intrauterine System

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Desire to have intrauterine contraceptive device after counseling about different contraceptive options and consented to the study.
• Normal menstrual bleeding cycles (24-35 days).

You may not qualify if:

• Nulliparity.
• Undiagnosed uterine bleeding.
• Any proven ovarian, uterine or endometrial pathology such as; uterine myoma, adenomyosis, endometrial polyps, ovarian cysts
• Contraceptive pills had not been taken during the previous 3 months and any previous IUD had been removed at least 1 month earlier
• Hemorrhagic disorders.
• Acute or chronic pelvic inflammatory disease
• Known uterine anomalies e.g., Bicornuate/septate Uterus.
• Anemia (hemoglobin \<10 g/dl).
• Diagnosis of active cervical infection
• Dysplasia in the cervix.
• Patients wishing post-partum or post-abortum IUD insertion

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

Study Officials

• Beni-Suef University

  Faculty of Medicine Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara A Salem, MD

CONTACT

01272842226; sara_abdallah100@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: August 30, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

EG (1)