Effect of Levonorgestrel Intrauterine System on Hemoglobin Level

April 12, 2025 updated by: Mariam Melad Matta, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Essam eldeen Rashad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. The study will include married women attending the outpatient clinics of the forementioned health facilities for contraception counseling
  2. Age between 18 and 45 years
  3. Women who choose LNG_IUS for contraception
  4. 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) 4. Any uterine abnormality making LNG_IUS insertion difficult (septate uterus or fibroid distorting the cavity) 5. Women within 6 months of delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Levonorgestrel intrauterine system insertion
Device: Levonorgestrel intrautrine system
Insertion of levonorgestrel intrautrine system and take a blood sample from the women to analyse it
Other Names:
  • Take a blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 6 months
To know the effect of LNG-IUDs in serum ferritin
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 12, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 12, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mirena (Company Internal)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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