Discontinuation Rate Among Copper IUD Users

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: Unknown
• Conditions: Contraceptive Device; Intrauterine
• Intervention / Treatment: Device: Cu-IUD

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: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: noha mohamed elzaydy
• Investigators: Study Director: Ain Shams Maternity Hospital, Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 19, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID 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