Impact of the traditional blind technique versus the novel ultrasound guided technique for office fitting of intra-uterine contraceptive devices on success of insertion, time required and patient satisfaction in healthy women with regular menstrual periods

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000526572
• Date of registration: 26/05/2015
• Prospective Registration: No
• Primary sponsor: Mervat Sheikhelarab Elsedeek
• Public title: Impact of the traditional blind technique versus the novel ultrasound guided technique for office fitting of intra-uterine contraceptive devices on success of insertion, time required and patient satisfaction in healthy women with regular menstrual periods
• Scientific title: Impact of the traditional blind technique versus the novel ultrasound guided technique for office fitting of intra-uterine contraceptive devices on success of insertion, time required and patient satisfaction in healthy women with regular menstrual periods.
• Date of first enrolment: 07/01/2013
• Target sample size: 100
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000526572.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Egypt

Contacts

• Name: Prof Mervat Sheikhelarab Elsedeek Omran

• Name: Prof Mervat Sheikhelarab Elsedeek Omran

Key inclusion & exclusion criteria

Inclusion criteria: request for contraception, regular menstrual periods, post-menstrual period, normal uterine cavity.
Exclusion criteria: Uterine pathology, amenorrheic women.

Age minimum: 20 Years
Age maximum: 45 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Contraception

Fertility control;
Fertility control

Intervention(s)

Intra-uterine contraceptive devices are inserted guided by transabdominal ultrasound with the probe held by an assistant through the procedure which require one to three minutes.

Primary Outcome(s)

Time required for procedure using stop watch.[end of the procedure]

success and ideal position of device as seen by ultrasound.[end of the procedure]

Secondary Outcome(s)

patient satisfaction using simple non validated questionnaire designed specifically for this study.[end of the procedure]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Mervat Sheikhelarab Elsedeek

Ethics review

Status: Approved
Approval date:
Contact:

Faculty of medicine, Alexandria University, Ethical review board.