Ultrasound Guided Intra-uterine Device Insertion | NCT02393495

Studies
Ultrasound Guided Intra-uterine Device Insertion

NCT02393495

Sponsor

Woman's Health University Hospital, Egypt

Status

Completed

Last Update Posted

Sep 1, 2015Estimated

Enrollment

102Actual

Phase

Not Applicable

Conditions

Contraception

Interventions

intrauterine device TCu 380A

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Jan 23, 2015

First Submission Date that Met QC Criteria

Mar 18, 2015

First Posted Date

Mar 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2015

Last Update Posted Date

Sep 1, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dina Mohamed Refaat Dakhly, Lecturer of Obstetrics and Gynecology, Woman's Health University Hospital, EgyptPrincipal Investigator

Lead Sponsor

Woman's Health University Hospital, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intrauterine device TCu 380A	Device		Non ultrasound guided group Ultrasound guided group	TCu 380A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dina MR Dakhly, MD	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr el ainy hospital		Cairo		12211	Egypt