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Clinical Trials/NCT06935968
NCT06935968Not yet recruitingNot Applicable

Effect of Levonorgestrel Intrautrine System on Hemoglobin Level and Iron Profile on Women Requiring Contraception

Assiut University0 sites100 target enrollmentStarted: May 1, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
100
Primary Endpoint
Change of blood haemoglobin level from time of insertion to 6 months after insertion
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed Description

Women come to family planning clinic to insert levonorgestrel intrautrine system and take a blood sample from her to analyse hemoglobin level

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •1.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)
  • •Any uterine abnormality making LNG_IUS insertion difficult (septate uterus or fibroid distorting the cavity)
  • •Women within 6 months of delivery

Arms & Interventions

Levonorgestrel intrauterine system insertion

Other

Intervention: Levonorgestrel intrautrine system (Device)

Outcomes

Primary Outcomes

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

Time Frame: 6 months

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mariam Melad Matta

Resident doctor

Assiut University

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