A Novel IUD Insertion Technique

Study Overview
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Brief Summary
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A previous trial performed by our research team, in order to reduce the pain associated with intrauterine device insertion, compared the novel technique of IUD insertion under the guidance of the trans-abdominal sonography to the traditional method of IUD insertion. It came up with the conclusion that the TAS guided IUD insertion is significantly lower in pain score and time taken for insertion, when compared with the traditional method. In this study our researchers aim to abolish the distracting effect of the technician and the TAS probe (which might have interfered with previous results).

Official Title
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Introducing Trans- Abdominal Guided Intrauterine Device Insertion, a Single Blinded Randomized Control Trial

Conditions
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Contraception

Intervention / Treatment
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* Device: intrauterine device TCu 380A
* Radiation: Trans-abdominal sonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females desiring contraception with the use of IUD Females with history of previous vaginal delivery 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAS guided IUD insertion<br>the 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. | Device: intrauterine device TCu 380A<br> <br> * Other names: TCu 380A;Radiation: Trans-abdominal sonography<br> <br> * Other names: TAS;|
| Experimental: Traditional IUD insertion<br>the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound. the trans-abdominal probe will also be placed by an assistant on the suprapubic region ( the image would be on freeze mode) as it is not actually used , it is just to make the same settings for the participant females. | Device: intrauterine device TCu 380A<br> <br> * Other names: TCu 380A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of pain during IUD insertion | Pain will be assessed by the use of visual analog scale (VAS). | 4 months |