Non Touch Technique for IUD Insertion

NCT ID: NCT02582281

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-03-31

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

intrauterine device TCu 380A

Intervention Type: DEVICE

Traditional IUD insertion

the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound.

Group Type: EXPERIMENTAL

intrauterine device TCu 380A

Intervention Type: DEVICE

Interventions

intrauterine device TCu 380A

Intervention Type: DEVICE

Other Intervention Names

TCu 380A

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Woman's Health University Hospital, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Dina Mohamed Refaat Dakhly

Lecturer of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina M Dakhly, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Kasr el aini hospital

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina M Dakhly, MD

Role: CONTACT

dinadakhly@gmail.com

01003498919 ext. 002

Facility Contacts

Dina M Dakhly, MD

Role: primary

Dinadakhly@gmail.com

01003498919 ext. 002

Other Identifiers

CU161020

Identifier Type: -

Identifier Source: org_study_id