Allis Clamp Versus Single-tooth Tenaculum

December 21, 2021 updated by: Brooke Andrews

Cervical Bleeding With Cervical Stabilization During IUD Placement: Allis Clamp Versus Single-tooth Tenaculum

This study aims to determine whether an Allis clamp is an effective clamp for cervical stabilization compared to a single-tooth tenaculum.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

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

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University Of Kentucky

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 to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Obtaining IUD

Exclusion Criteria:

-

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IUD placement with allis clamp
Procedure: Allis clamp
Physicians utilized an Allis clam for cervical stabilization during IUD placement.
ACTIVE_COMPARATOR: IUD placement with single tooth tenaculum
Procedure: Single-tooth tenaculum
Physicians utilized a single-tooth tenaculum clam for cervical stabilization during IUD placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who experienced bleeding after IUD placement
Time Frame: At the time of IUD insertion
Number of patients who experienced bleeding after IUD placement with an Allis clamp or single-tooth tenaculum.
At the time of IUD insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IUD insertion success rate
Time Frame: At the time of IUD insertion
The percentage of participants who successfully had an IUD placed with an Allis clamp or single-tooth tenaculum.
At the time of IUD insertion
Number of interventions required for cervical clamp site bleeding hemostasis
Time Frame: At the time of IUD insertion
Number of interventions required to achieve hemostasis after IUD placement with an Allis clamp or single-tooth tenaculum.
At the time of IUD insertion
Time to hemostasis
Time Frame: At the time of IUD insertion
The time in seconds required to achieve hemostasis after IUD placement with an Allis clamp or single-tooth tenaculum.
At the time of IUD insertion
Participant reported pain
Time Frame: At the time of IUD insertion
Pain reported by the participant (0-10 where a higher number indicates greater pain) at the time of IUD placement with n Allis clamp or single-tooth tenaculum.
At the time of IUD insertion

Collaborators and Investigators

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

Sponsor

Brooke Andrews

Investigators

  • Principal Investigator: Bryan Rone, MD, University Of Kentucky

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)

March 1, 2017

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

December 21, 2021

First Posted (ACTUAL)

January 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-1110-P3K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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