Non Touch Technique for IUD Insertion

The Non Touch Technique for Intrauterine Device Insertion, a Single Blinded Randomized Control Trial

The non touch technique is a modification of the traditional intrauterine device insertion technique. It abolishes the use of Allis and uterine sounding.

Study Overview

• Status: Unknown
• Conditions: Contraception
• Intervention / Treatment: Device: intrauterine device TCu 380A

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12211
    • Recruiting
    • Kasr El Aini Hospital
    • Principal Investigator: Dina M Dakhly, MD
    • Contact: Dina M Dakhly, MD; Phone Number: 002 01003498919; Email: dinadakhly@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non touch technique; the intrauterine device TCu 380A will be inserted in the conventional method as follows: First, insert the speculum and view the cervix. The position of the cervix will very often confirm if the uterus is anteverted or retroverted. Second, using the Allis forceps hold the back of a cotton-ball swab and dip it into a povidine-iodine disinfectant solution, or equivalent. Swab the cervix. Then cut the threads to the appropriate length and remove the speculum. This technique omits the sounding of the uterus which is considered a quintessential procedure before IUD insertion for which there is no one established piece of evidence.The IUD is checked afterwards by transvaginal ultrasound.	Device: intrauterine device TCu 380A; Other Names: TCu 380A
Experimental: Traditional IUD insertion; the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound.	Device: intrauterine device TCu 380A; Other Names: TCu 380A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of pain during IUD insertion	Pain will be assessed by the use of visual analog scale (VAS).	5 months

Collaborators and Investigators

• Sponsor: Woman's Health University Hospital, Egypt
• Investigators: Principal Investigator: Dina M Dakhly, MD, Cairo University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CU161020