Discontinuation Rate Among Copper IUD Users

January 12, 2018 updated by: noha mohamed elzaydy

Discontinuation Rates Among Copper Intrauterine Device Users in Primary Healthcare Unit and University Clinic. Is There a Difference?

The intrauterine device (IUD) is one of the most widely used reversible, long-term contraceptive methods in the world. But despite all its advantages; discontinuation rate of IUD ranged from 9.6% to 37.3 % (according to Demographic and Health Surveys data). In Egypt, in 2014, the discontinuation rate of IUD (within 12 months of use) was 14.3%.This study explores the differences around this rate in Egyptian university clinic and primary healthcare clinic with detailed percentages of possible causes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of the study is to compare between primary health care unit and university family planning clinic in discontinuation rate among copper IUD users.

  1. The Research Hypothesis: (Null hypothesis)

    • In women using copper IUD, discontinuation rate in primary health care unit and university clinic may be similar.

  2. The Research Question:

    • In women using copper IUD, Does discontinuation rate in primary health care unit and university clinic differ?

  3. METHODOLOGY:

Patients and Methods

• Study setting:

  • Family planning Outpatient clinic of Ain Shams Maternity Hospital, (ASUMH)

  • primary health care unit in ain shams area

    • Study population:

  • Study period: 1 year

  • Sample size: was calculated using Sample size computer program 11. After review of literature, no previous similar study was done before, so assume a discontinuation rate of 50% among Cu-IUD users in primary healthcare unit and 25% among Cu-IUD users in university clinic. Based on these values; the study will include 170 Cu-IUD users; equally selected as 85 subjects from each clinic. But due to the expected drop outs, recruitment will start by 200 women from each clinic.

    • Statistics:

      • Descriptive statistics for measured variables will be expressed as range, mean and standard deviation (for metric data); range, median and interquartile range (for discrete data); and number and proportions (for categorical data). Cu-IUD discontinuation findings in each clinic will be compared using the t-test or the Mann-whitney U test depending on whether the measured parameters are guassian variables. A P-value of 0.05 or less will be considered statistically significant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Ain Shams
      • Cairo, Ain Shams, Egypt, 11566
        • Recruiting
        • Ain Shams Maternity Hospital
        • Contact:
          • Ain Shams Maternity hospital
          • Phone Number: 202 02-26845870
          • Email: socea@socea.org

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

women attending family planning for Cu- IUD insertion who meet inclusion criteria

Description

Inclusion Criteria:

  • 1. Age from 18-49 years. 2. Women planning for Cu-IUD insertion as a contraceptive method.

Exclusion Criteria:

  • 1. Any woman with condition included in Category 3 or 4 for Cu-IUD in medical eligibility criteria for contraceptive use (MEC) -World Health Organization-2015.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
university clinic
  • Enrollment: 200 Subjects will be enrolled from women attending family planning clinic for Cu- IUD insertion
  • Informed Consent: All participants will give their informed consent prior to enrollment.
  • Data collection & recording: Data of each patient will be recorded in a Case Record Form (CRF).
  • Follow up visits /questionnaire: will be conducted from each subject at 6 months and 12 months after Cu-IUD insertion. User satisfaction score and haemoglobin serum level will be included in the questionnaire.
Device: Cu-IUD
Copper Intra-uterine device used as contraceptive method
primary healthcare unit clinic
  • Enrollment: 200 Subjects will be enrolled from women attending family planning clinic for Cu- IUD insertion
  • Informed Consent: All participants will give their informed consent prior to enrollment.
  • Data collection & recording: Data of each patient will be recorded in a Case Record Form (CRF).
  • Follow up visits /questionnaire: will be conducted from each subject at 6 months and 12 months after Cu-IUD insertion. User satisfaction score and haemoglobin serum level will be included in the questionnaire.
Device: Cu-IUD
Copper Intra-uterine device used as contraceptive method

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
measure discontinuation rate
Time Frame: 1 year
• To measure the discontinuation rate among copper IUD users in primary health care unit and university clinic.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
exclude anemia
Time Frame: 1 year
To exclude Anemia from reasons of Cu-IUD discontinuation.
1 year
comparison
Time Frame: 1 year
• To identify reasons of discontinuation among Copper IUD users and percentage of each cause in both university clinic and primary health care unit.
1 year
users" satisfaction
Time Frame: 1 year
• To measure copper IUD users' satisfaction of this contraceptive method in both university clinic and primary health care unit.
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
noha mohamed elzaydy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ain Shams Maternity Hospital, Ain Shams Maternity Hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cu-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.

Clinical Trials on Contraceptive Device; Intrauterine

Clinical Trials on Cu-IUD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings