Discontinuation Rate Among Copper IUD Users

NCT ID: NCT03404102

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-17
• Study Completion Date: 2018-09-30

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.

Conditions

Contraceptive Device; Intrauterine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cu-IUD

Intervention Type: DEVICE

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.

Cu-IUD

Intervention Type: DEVICE

Copper Intra-uterine device used as contraceptive method

Interventions

Cu-IUD

Copper Intra-uterine device used as contraceptive method

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

noha mohamed elzaydy

OTHER

Sponsor Role: lead

Responsible Party

noha mohamed elzaydy

researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ain Shams Maternity Hospital

Role: STUDY_DIRECTOR

Ain Shams Maternity Hospital

Locations

Ain Shams Maternity hospital

Cairo, Ain Shams, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

noha elzaydy, M.B.B.Ch.

Role: CONTACT

nohaelzaydy@gmail.com

01008309518 ext. 202

Facility Contacts

Ain Shams Maternity hospital

Role: primary

socea@socea.org

02-26845870 ext. 202

Other Identifiers

Cu-IUD

Identifier Type: -

Identifier Source: org_study_id