Ultrasound Guided Intra-uterine Device Insertion

NCT ID: NCT02393495

Last Updated: 2015-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

intrauterine device TCu 380A

Intervention Type DEVICE

Non ultrasound guided group

the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound.

Group Type EXPERIMENTAL

intrauterine device TCu 380A

Intervention Type DEVICE

Interventions

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intrauterine device TCu 380A

Intervention Type DEVICE

Other Intervention Names

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TCu 380A

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Woman's Health University Hospital, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Dina Mohamed Refaat Dakhly

Lecturer of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina MR Dakhly, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr el ainy hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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22012015

Identifier Type: -

Identifier Source: org_study_id

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