Ultrasound Guided Intra-uterine Device Insertion
A Further Step Towards Painless Intrauterine Device Insertion, a Randomized Control Trial
1 other identifier
interventional
102
1 country
1
Brief Summary
Different studies have been made in an attempt to reduce the pain and the duration of the process of outpatient insertion of the intrauterine device. in this trial, the investigators aim to insert the IUD under ultrasonographic guidance, which can help to reduce the pain, decrease the process of insertion, in addition, it reduces the incidence of malposition of IUD as well as the risk of complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedSeptember 1, 2015
August 1, 2015
6 months
January 23, 2015
August 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of degree of pain during IUD insertion
Pain will be assessed by the use of visual analog scale, Pain rating scale
6 months
Study Arms (2)
Ultrasound guided group
EXPERIMENTALthe female will be asked to be full bladder. the trans-abdominal probe will be placed by an assistant on the suprapubic region. under speculum examination, the intrauterine device IUD (TCu 380A) will be placed till it reaches the fundus of the uterus and then released.
Non ultrasound guided group
EXPERIMENTALthe intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound.
Interventions
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kasr el ainy hospital
Cairo, 12211, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Dina MR Dakhly, MD
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Obstetrics and Gynecology
Study Record Dates
First Submitted
January 23, 2015
First Posted
March 19, 2015
Study Start
February 1, 2015
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
September 1, 2015
Record last verified: 2015-08