An observational study in Contraceptive Device; Intrauterine, sponsored by noha mohamed elzaydy. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-19.
Sponsored by noha mohamed elzaydy · Observational
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.
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)
The Research Question:
Patients and Methods
primary health care unit in ain shams area
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:
women attending family planning for Cu- IUD insertion who meet inclusion criteria
Exclusion Criteria:
* 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
* 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
measure discontinuation rate
• To measure the discontinuation rate among copper IUD users in primary health care unit and university clinic.
Time frame: 1 year
exclude anemia
To exclude Anemia from reasons of Cu-IUD discontinuation.
Time frame: 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.
Time frame: 1 year
users" satisfaction
• To measure copper IUD users' satisfaction of this contraceptive method in both university clinic and primary health care unit.
Time frame: 1 year
Plan to share: Undecided
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