Contraceptive Device; IntrauterineNCT03404102
Discontinuation Rate Among Copper IUD Users
An observational study of Contraceptive Device; Intrauterine, run by noha mohamed elzaydy at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Device; Intrauterine
- What is being tested?
- Cu-IUD
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Oct 2017to Sep 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women attending family planning for Cu- IUD insertion who meet inclusion criteria
Who may be able to join
- 1. Age from 18-49 years. 2. Women planning for Cu-IUD insertion as a contraceptive method.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity hospital
Cairo, Ain Shams, 11566
Ain Shams Maternity hospital, 02-26845870 ext. 202, socea@socea.org
About this study
Official title: 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.
Read the 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.
- The Research Hypothesis: (Null hypothesis)
- In women using copper IUD, discontinuation rate in primary health care unit and university clinic may be similar.
- The Research Question:
- In women using copper IUD, Does discontinuation rate in primary health care unit and university clinic differ?
- 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
- Being tested
- Cu-IUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cu-IUDDevice
Copper Intra-uterine device used as contraceptive method
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cu-IUD | |
| 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. Receives: Device: Cu-IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure discontinuation rate
- To measure the discontinuation rate among copper IUD users in primary health care unit and university clinic.
Measured: 1 year
Secondary outcomes (3)
exclude anemia
To exclude Anemia from reasons of Cu-IUD discontinuation.
Measured: 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.
Measured: 1 year
users" satisfaction
- To measure copper IUD users' satisfaction of this contraceptive method in both university clinic and primary health care unit.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start17 Oct 2017
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive Device; IntrauterineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- noha mohamed elzaydy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, noha mohamed elzaydy, Ain Shams Maternity Hospital
- Investigators
- Ain Shams Maternity Hospital, Study director, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404102
- Sponsor's protocol ID
- Cu-IUD
- Status last verified
- Jan 2018
- First submitted
- 12 Jan 2018
- Last updated
- 19 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation Rates Among Copper Intrauterine Device Users in Primary Healthcare Unit and University Clinic. Is There a Difference?
- ClinicalTrials.gov ID
- NCT03404102
- Acronym / sponsor ID
- Cu-IUD
- Conditions
- Contraceptive Device; Intrauterine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- noha mohamed elzaydyUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- The Research Hypothesis: (Null hypothesis)
- In women using copper IUD, discontinuation rate in primary health care unit and university clinic may be similar.
- The Research Question:
- In women using copper IUD, Does discontinuation rate in primary health care unit and university clinic differ?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| university clinic | – | Device: Cu-IUD* 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. |
| primary healthcare unit clinic | – | Device: Cu-IUD* 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women attending family planning for Cu- IUD insertion who meet inclusion criteria
Key inclusion criteria (1 listed)
- 1. Age from 18-49 years. 2. Women planning for Cu-IUD insertion as a contraceptive method.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cu-IUDCopper Intra-uterine device used as contraceptive method | Device | primary healthcare unit clinic, university clinic |
Primary outcome
measure discontinuation rate
Time frame: 1 year
• To measure the discontinuation rate among copper IUD users in primary health care unit and university clinic.
3 secondary outcomes
exclude anemia
Time frame: 1 year
comparison
Time frame: 1 year
users" satisfaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Contraceptive Device; Intrauterine
Recruiting
Structured Contraceptive Counseling During Pregnancy
Contraception, Intrauterine Device
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ain Shams Maternity Hospital study director
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraceptive Device; Intrauterine, run by noha mohamed elzaydy at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact noha elzaydy, M.B.B.Ch. (01008309518 ext. 202, nohaelzaydy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure discontinuation rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018; AzTrials last refreshed its copy on 29 Oct 2026.