Clinical trial NCT03404102: Discontinuation Rate Among Copper IUD Users
Official title: Discontinuation Rates Among Copper Intrauterine Device Users in Primary Healthcare Unit and University Clinic. Is There a Difference?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Contraceptive Device; Intrauterine
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women attending family planning for Cu- IUD insertion who meet inclusion criteria

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.

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.

Primary outcomes:
measure: measure discontinuation rate
timeFrame: 1 year
Secondary outcomes:
measure: exclude anemia
timeFrame: 1 year
measure: comparison
timeFrame: 1 year
measure: users" satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity hospital
state: Ain Shams
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Ain Shams Maternity Hospital
role: STUDY_DIRECTOR
References: