Effect of Levonorgestrel Intrauterine System on Hemoglobin Level

NCT06935968 | Not Yet Recruiting

• 1 other identifier: Mirena
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

To study the effect of LNG-IUS on improving iron status in reproductive-aged women presenting for contraception.

Conditions

Hemoglobin; Deficiency

Outcome Measures

Primary Outcomes (1)

• Change of blood haemoglobin level from time of insertion to 6 months after insertion

  To know the effect of LNG-IUDs on hemoglobin level after insertion

  6 months

Secondary Outcomes (1)

• Change of serum ferritin level from time of insertion to 6 months after insertionPrevalence of iron deficiency and iron deficiency anemia in women requiring contraception in our community

  6 months

Study Arms (1)

Levonorgestrel intrauterine system insertion

OTHER

Device: Levonorgestrel intrautrine system

Interventions

Levonorgestrel intrautrine system DEVICE

Insertion of levonorgestrel intrautrine system and take a blood sample from the women to analyse it

Also known as: Take a blood sample

Levonorgestrel intrauterine system insertion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The study will include married women attending the outpatient clinics of the forementioned health facilities for contraception counseling
• Age between 18 and 45 years
• Women who choose LNG\_IUS for contraception
• Any parity including nulliparous

You may not qualify if:

• Women with any inherited hemoglobinopathy (thalassemia, sickle cell anemia) or acquired hemolytic anemia 2.Women with sever iron deficiency anemia requiring immediate treatment 3.Women with any contraindication to Mirena insertion (pelvic inflammatory disease, cervical or vaginal infection, cervical cancer) 4. Any uterine abnormality making LNG\_IUS insertion difficult (septate uterus or fibroid distorting the cavity) 5. Women within 6 months of delivery

Sponsors & Collaborators

• Assiut University: lead

Central Study Contacts

Mariam Melad

CONTACT

01020214925; mariomamelad8@gmail.com

Essam eldeen Rashad

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 20, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04