Ultrasound Guided Intra-uterine Device Insertion

Contraception Clinical Trial

Official title:

A Further Step Towards Painless Intrauterine Device Insertion, a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393495
• Other study ID #: 22012015
• Status: Completed
• Phase: N/A
• First received: January 23, 2015
• Last updated: August 30, 2015
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Different studies have been made in an attempt to reduce the pain and the duration of the process of outpatient insertion of the intrauterine device. in this trial, the investigators aim to insert the IUD under ultrasonographic guidance, which can help to reduce the pain, decrease the process of insertion, in addition, it reduces the incidence of malposition of IUD as well as the risk of complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• 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

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

• Have ovarian cancer

• Have AIDS (unless clinically well on anti-retroviral therapy)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• intrauterine device TCu 380A

Locations

Country	Name	City	State
Egypt	Kasr el ainy 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	Assessment of degree of pain during IUD insertion	Pain will be assessed by the use of visual analog scale, Pain rating scale	6 months	No