CompletedNCT02393495Updated Sep 1, 2015

Ultrasound Guided Intra-uterine Device Insertion

An interventional study of intrauterine device TCu 380A in Contraception, sponsored by Woman's Health University Hospital, Egypt. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-01.

Sponsored by Woman's Health University Hospital, Egypt · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 102
Allocation: Randomized
Ages: 20 Years to 45 Years
Sex: Female

Study 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.

Conditions studied

Contraception

In context

Lead sponsor

Woman's Health University Hospital, Egypt is the lead sponsor of 46 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 45 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Females desiring contraception with the use of IUD

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 102 participants (actual)

Study arms

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

Interventions

Deviceintrauterine device TCu 380A
Also known as: TCu 380A

What researchers measure

Primary outcomes

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

Study locations

1 site

Kasr el ainy hospital
Cairo, 12211, Egypt

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02393495
Lead sponsor: Woman's Health University Hospital, Egypt
Responsible party: Dina Mohamed Refaat Dakhly (Lecturer of Obstetrics and Gynecology, Woman's Health University Hospital, Egypt) — Principal investigator
First posted: Mar 19, 2015
Start date: Feb 2015
Primary completion: Aug 2015
Completion: Aug 2015
Last update: Sep 1, 2015

Study contacts

Dina MR Dakhly, MD

principal investigator · Cairo University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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