Non Touch Technique for IUD Insertion

Not Applicable

• Conditions: Contraception
• Interventions: Device: intrauterine device TCu 380A

• Registration Number: NCT02582281
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-19
• Last Update Submitted: 2015-10-19
• Study First Posted: 2015-10-21
• Last Update Posted: 2015-10-21
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non touch technique	intrauterine device TCu 380A	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.
Traditional IUD insertion	intrauterine device TCu 380A	the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound.

Primary Outcome Measures

Name	Time	Method
degree of pain during IUD insertion	5 months	Pain will be assessed by the use of visual analog scale (VAS).

Trial Locations

Locations (1)

Kasr el aini hospital; 🇪🇬 Cairo, Egypt