Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT03404102
Status:
UNKNOWN
Last Update Posted:
2018-01-19
First Post:
2018-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Discontinuation Rate Among Copper IUD Users
Sponsor:
noha mohamed elzaydy
Organization:
Study Overview
Official Title:
Discontinuation Rates Among Copper Intrauterine Device Users in Primary Healthcare Unit and University Clinic. Is There a Difference?
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: