A Novel IUD Insertion Technique

Contraception Clinical Trial

Official title:

Introducing Trans- Abdominal Guided Intrauterine Device Insertion, a Single Blinded Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02582268
• Other study ID #: CU151020
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2015
• Last updated: October 19, 2015
• Start date: October 2015
• Est. completion date: February 2016

Study information

• Verified date: October 2015
• Source: Woman's Health University Hospital, Egypt
• Contact: Dina M Dakhly, MD
• Phone: 01003498919
• Email: dinadakhly[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A previous trial performed by our research team, in order to reduce the pain associated with intrauterine device insertion, compared the novel technique of IUD insertion under the guidance of the trans-abdominal sonography to the traditional method of IUD insertion. It came up with the conclusion that the TAS guided IUD insertion is significantly lower in pain score and time taken for insertion, when compared with the traditional method. In this study our researchers aim to abolish the distracting effect of the technician and the TAS probe (which might have interfered with previous results).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Females desiring contraception with the use of IUD

• Females with history of previous vaginal delivery

Exclusion Criteria:

• Are pregnant or think they may be pregnant

• Septic pregnancy or abortion

• Have unexplained abnormal vaginal bleeding

• Have untreated cervical cancer

• Have malignant gestational trophoblastic disease

• Have uterine cancer

• Have uterine abnormalities

• Have or may have had a pelvic infection within the past three months

• Have or may have any sexually transmitted disease

• Have pelvic tuberculosis

• Are postpartum between 48 hours and 4 weeks

• Have benign gestational trophoblastic disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• intrauterine device TCu 380A

Radiation:
• Trans-abdominal sonography

Locations

Country	Name	City	State
Egypt	Kasr el aini hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of pain during IUD insertion	Pain will be assessed by the use of visual analog scale (VAS).	4 months	No