NCT02582281UnknownNot Applicable
The Non Touch Technique for Intrauterine Device Insertion, a Single Blinded Randomized Control Trial
Woman's Health University Hospital, Egypt2 sites in 1 country100 target enrollmentStarted: October 1, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- degree of pain during IUD insertion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
degree of pain during IUD insertion
Time Frame: 5 months
Pain will be assessed by the use of visual analog scale (VAS).
Secondary Outcomes
No secondary outcomes reported
Investigators
Dina Mohamed Refaat Dakhly
Lecturer of Obstetrics and Gynecology
Woman's Health University Hospital, Egypt
Study Sites (2)
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