Discontinuation Rate Among Copper IUD Users

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The Research Hypothesis: (Null hypothesis) • In women using copper IUD, discontinuation rate in primary health care unit and university clinic may be similar. The Research Question: • In women using copper IUD, Does discontinuation rate in primary health care unit and university clinic differ? 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.

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

Conditions
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Contraceptive Device; Intrauterine

Intervention / Treatment
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* Device: Cu-IUD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| university clinic<br>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<br>* Copper Intra-uterine device used as contraceptive method<br>|
| primary healthcare unit clinic<br>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<br>* Copper Intra-uterine device used as contraceptive method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure discontinuation rate | • To measure the discontinuation rate among copper IUD users in primary health care unit and university clinic. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exclude anemia | To exclude Anemia from reasons of Cu-IUD discontinuation. | 1 year | 
| comparison | • 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 | • To measure copper IUD users' satisfaction of this contraceptive method in both university clinic and primary health care unit. | 1 year |