Allis Clamp Versus Single-tooth Tenaculum

• Sponsor: Brooke Andrews (Other)
• Overall Status: Completed
• CT.gov ID: NCT05187078
• Collaborator: (none)
• Enrollment: 95
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
IUD	Procedure: Allis clamp; Procedure: Single-tooth tenaculum	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Physician participants were aware of assignment to utilize the single-toothed tenaculum clamp or allis clamp directly prior to IUD placement procedure. Participants were blinded to the clamp assigned.
• Primary Purpose: Supportive Care
• Official Title: Cervical Bleeding With Cervical Stabilization During IUD Placement: Allis Clamp Versus Single-tooth Tenaculum
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Obtaining IUD

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40506

Sponsors and Collaborators

• Brooke Andrews

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brooke Andrews, Resident Physician, OB/Gyn, University of Kentucky
• ClinicalTrials.gov Identifier: NCT05187078
• Other Study ID Numbers: 16-1110-P3K
• First Posted: Jan 11, 2022
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Brooke Andrews, Resident Physician, OB/Gyn, University of Kentucky: Cervical stabilization

Study Results

No Results Posted as of Jan 11, 2022