Allis Clamp Versus Single-tooth Tenaculum

IUD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05187078
• Other study ID #: 16-1110-P3K
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: December 2021
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Obtaining IUD Exclusion Criteria: -

Related Conditions & MeSH terms

• IUD

Intervention

Procedure:
• Allis clamp
Physicians utilized an Allis clam for cervical stabilization during IUD placement.
• Single-tooth tenaculum
Physicians utilized a single-tooth tenaculum clam for cervical stabilization during IUD placement.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Andrews

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who experienced bleeding after IUD placement	Number of patients who experienced bleeding after IUD placement with an Allis clamp or single-tooth tenaculum.	At the time of IUD insertion
Secondary	IUD insertion success rate	The percentage of participants who successfully had an IUD placed with an Allis clamp or single-tooth tenaculum.	At the time of IUD insertion
Secondary	Number of interventions required for cervical clamp site bleeding hemostasis	Number of interventions required to achieve hemostasis after IUD placement with an Allis clamp or single-tooth tenaculum.	At the time of IUD insertion
Secondary	Time to hemostasis	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
Secondary	Participant reported pain	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