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Discontinuation Rate Among Copper IUD Users

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03404102
Enrollment
400
Registered
2018-01-19
Start date
2017-10-17
Completion date
2018-09-30
Last updated
2018-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive Device; Intrauterine

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.

Interventions

DEVICECu-IUD

Copper Intra-uterine device used as contraceptive method

Sponsors

noha mohamed elzaydy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
measure discontinuation rate1 year• To measure the discontinuation rate among copper IUD users in primary health care unit and university clinic.

Secondary

MeasureTime frameDescription
exclude anemia1 yearTo exclude Anemia from reasons of Cu-IUD discontinuation.
comparison1 year• To identify reasons of discontinuation among Copper IUD users and percentage of each cause in both university clinic and primary health care unit.
users satisfaction1 year• To measure copper IUD users' satisfaction of this contraceptive method in both university clinic and primary health care unit.

Countries

Egypt

Contacts

Primary Contactnoha elzaydy, M.B.B.Ch.
nohaelzaydy@gmail.com01008309518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026