A Novel IUD Insertion Technique

Not Applicable

• Conditions: Contraception
• Interventions: Device: intrauterine device TCu 380A; Radiation: Trans-abdominal sonography

• Registration Number: NCT02582268
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-19
• Last Update Submitted: 2015-10-19
• Study First Posted: 2015-10-21
• Last Update Posted: 2015-10-21
• Primary Completion: 2016-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAS guided IUD insertion	intrauterine device TCu 380A	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.
Traditional IUD insertion	intrauterine device TCu 380A	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.
TAS guided IUD insertion	Trans-abdominal sonography	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.

Primary Outcome Measures

Name	Time	Method
degree of pain during IUD insertion	4 months	Pain will be assessed by the use of visual analog scale (VAS).

Trial Locations

Locations (1)

Kasr el aini hospital; 🇪🇬 Cairo, Egypt