Allis Clamp Versus Single-tooth Tenaculum

Not Applicable

Completed

• Conditions: IUD
• Interventions: Procedure: Single-tooth tenaculum; Procedure: Allis clamp

• Registration Number: NCT05187078
• Lead Sponsor: Brooke Andrews

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-21
• Last Update Submitted: 2021-12-21
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

Inclusion Criteria

• Obtaining IUD

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IUD placement with single tooth tenaculum	Single-tooth tenaculum	-
IUD placement with allis clamp	Allis clamp	-

Primary Outcome Measures

Name	Time	Method
Number of patients who experienced bleeding after IUD placement	At the time of IUD insertion	Number of patients who experienced bleeding after IUD placement with an Allis clamp or single-tooth tenaculum.

Secondary Outcome Measures

Name	Time	Method
Time to hemostasis	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.
IUD insertion success rate	At the time of IUD insertion	The percentage of participants who successfully had an IUD placed with an Allis clamp or single-tooth tenaculum.
Number of interventions required for cervical clamp site bleeding hemostasis	At the time of IUD insertion	Number of interventions required to achieve hemostasis after IUD placement with an Allis clamp or single-tooth tenaculum.
Participant reported pain	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.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States