Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device

August 13, 2023 updated by: Sara Abdallah Mohamed Salem, Beni-Suef University

Correlation Between Uterine Artery Doppler Indices and Menstrual Changes After Insertion of Copper Intrauterine Contraceptive Device and Levonorgestrel Intrauterine System

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

165

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 Locations

  • Egypt
    • Beni Suef
      • Banī Suwayf, Beni Suef, Egypt, 62521
        • Beni-suef university Hospital

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

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.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
copper T-380 IUD
Other Names:
  • silverline
Levonorgestrel Intrauterine System
Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD .
Device: LNG-IUS
Levonorgestrel Intrauterine System
Other Names:
  • mirena

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Beni-Suef University, Faculty of medicine Beni-Suef 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)

August 30, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Doppler IUD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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