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Completed

NCT Number: NCT05187078

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.

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Key information

Conditions

IUD

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obtaining IUD

Exclusion criteria

-

Treatment and study plan

Allis clamp

Procedure

Physicians utilized an Allis clam for cervical stabilization during IUD placement.

Single-tooth tenaculum

Procedure

Physicians utilized a single-tooth tenaculum clam for cervical stabilization during IUD placement.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Brooke Andrews

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 11, 2022
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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