Discontinuation Rate Among Copper IUD Users

Contraceptive Device; Intrauterine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03404102
• Other study ID #: Cu-IUD
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2018
• Last updated: January 12, 2018
• Start date: October 17, 2017
• Est. completion date: September 2018

Study information

• Verified date: January 2018
• Source: Ain Shams Maternity Hospital
• Contact: noha elzaydy, M.B.B.Ch.
• Phone: 01008309518
• Email: nohaelzaydy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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:

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

o primary health care unit in ain shams area

• Study population:

o Study period: 1 year

o 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraceptive Device; Intrauterine

Intervention

Device:
• Cu-IUD
Copper Intra-uterine device used as contraceptive method

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity hospital	Cairo	Ain Shams

Sponsors (1)

Lead Sponsor	Collaborator
noha mohamed elzaydy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure discontinuation rate	• To measure the discontinuation rate among copper IUD users in primary health care unit and university clinic.	1 year
Secondary	exclude anemia	To exclude Anemia from reasons of Cu-IUD discontinuation.	1 year
Secondary	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
Secondary	users" satisfaction	• To measure copper IUD users' satisfaction of this contraceptive method in both university clinic and primary health care unit.	1 year