Discontinuation Rate Among Copper IUD Users

NCT03404102 | Unknown

• 1 other identifier: Cu-IUD
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraceptive Device; Intrauterine

Outcome Measures

Primary Outcomes (1)

• measure discontinuation rate

  • To measure the discontinuation rate among copper IUD users in primary health care unit and university clinic.

  1 year

Secondary Outcomes (3)

• exclude anemia

  1 year

• comparison

  1 year

• users" satisfaction

  1 year

Study Arms (2)

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

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

Interventions

Cu-IUD DEVICE

Copper Intra-uterine device used as contraceptive method

primary healthcare unit clinic; university clinic

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

women attending family planning for Cu- IUD insertion who meet inclusion criteria

You may qualify if:

• \. Age from 18-49 years. 2. Women planning for Cu-IUD insertion as a contraceptive method.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• noha mohamed elzaydy: lead

Study Sites (1)

Ain Shams Maternity hospital

Cairo, Ain Shams, 11566, Egypt

RECRUITING

Study Officials

• Ain Shams Maternity Hospital

  Ain Shams Maternity Hospital

  STUDY DIRECTOR

Central Study Contacts

noha elzaydy, M.B.B.Ch.

CONTACT

01008309518; nohaelzaydy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: October 17, 2017
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 19, 2018

Record last verified: 2018-01

Locations

EG (1)