Simplified IUD Insertion Technique (SIIT)

December 1, 2022 updated by: Paul D Blumenthal, Stanford University

Simplified IUD Insertion Technique: A Randomized Controlled Trial

This is a randomized controlled trial that compares traditional IUD insertion with that of a no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD placement is safe and effective without pre-procedural assessment of uterine size, direction, or depth.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women 18 years and older presenting to contraceptive clinic in Gaborone, Botswana for IUD insertion and have ability to give informed consent.

Exclusion Criteria:

  • Known contradictions to copper IUD, inability to comply with study protocol

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Arm 1: Traditional IUD Insertion
Standard IUD insertion according to package insert. Bimanual pelvic exam to assess uterine size and position will be performed. Uterine sound will be used to measure depth of uterus prior to insertion.
EXPERIMENTAL: Arm 2: Simplified IUD Insertion
Simplified, investigational IUD insertion performed. No bimanual pelvic exam or uterine sounding.
Procedure: Simplified IUD Insertion
IUD Insertion with no bimanual pelvic exam or uterine sounding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correct IUD Placement Immediately Post-Insertion
Time Frame: Immediately post-insertion
Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at time of insertion as visualized by transvaginal ultrasound.
Immediately post-insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correct IUD Placements 4-6 Weeks Post-Insertion
Time Frame: 4-6 weeks post-insertion
Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at 4-6 weeks after insertion as visualized by transvaginal ultrasound.
4-6 weeks post-insertion
Patient Satisfaction with IUD Insertion
Time Frame: Immediately Post-Insertion
Visual Analogue Scale (VAS)
Immediately Post-Insertion
Patient Pain Scores (VAS)
Time Frame: Immediately Post-Insertion
Visual Analogue Scale (VAS)
Immediately Post-Insertion

Collaborators and Investigators

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

Sponsor

Stanford 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 (ACTUAL)

January 1, 2018

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

October 1, 2020

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (ESTIMATE)

April 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-35138

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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