Non Touch Technique for IUD Insertion

NCT02582281 | Unknown DMC

• 1 other identifier: CU161020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• degree of pain during IUD insertion

  Pain will be assessed by the use of visual analog scale (VAS).

  5 months

Study Arms (2)

Non touch technique

EXPERIMENTAL

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

Traditional IUD insertion

EXPERIMENTAL

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

Device: intrauterine device TCu 380A

Interventions

intrauterine device TCu 380A DEVICE

Also known as: TCu 380A

Non touch technique; Traditional IUD insertion

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females desiring contraception with the use of IUD

You may not qualify if:

• 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)

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Kasr el aini hospital

Cairo, Cairo Governorate, 12211, Egypt

RECRUITING

Study Officials

• Dina M Dakhly, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina M Dakhly, MD

CONTACT

01003498919; dinadakhly@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

EG (1)