A Novel IUD Insertion Technique

October 19, 2015 updated by: Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt

Introducing Trans- Abdominal Guided Intrauterine Device Insertion, a Single Blinded Randomized Control Trial

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12211
        • Recruiting
        • Kasr El Aini Hospital
        • Principal Investigator:
          • Dina M Dakhly, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAS guided IUD insertion
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
Other Names:
  • TCu 380A
Radiation: Trans-abdominal sonography
Other Names:
  • TAS
Experimental: Traditional IUD insertion
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.
Device: intrauterine device TCu 380A
Other Names:
  • TCu 380A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of pain during IUD insertion
Time Frame: 4 months
Pain will be assessed by the use of visual analog scale (VAS).
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Woman's Health University Hospital, Egypt

Investigators

  • Principal Investigator: Dina M Dakhly, MD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CU151020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraception

Clinical Trials on intrauterine device TCu 380A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe