Ultrasound Guided Intra-uterine Device Insertion

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Device: intrauterine device TCu 380A

• Registration Number: NCT02393495
• Lead Sponsor: Woman's Health University Hospital, Egypt

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-23
• Study Start: 2015-02
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-19
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-30
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound guided group	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.
Non ultrasound guided group	intrauterine device TCu 380A	the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound.

Primary Outcome Measures

Name	Time	Method
Assessment of degree of pain during IUD insertion	6 months	Pain will be assessed by the use of visual analog scale, Pain rating scale

Trial Locations

Locations (1)

Kasr el ainy hospital; 🇪🇬 Cairo, Egypt