NCT05187078

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

December 21, 2021

Last Update Submit

December 21, 2021

Conditions

IUD

Keywords

Cervical stabilization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • IUD insertion success rate

    At the time of IUD insertion

  • Number of interventions required for cervical clamp site bleeding hemostasis

    At the time of IUD insertion

  • Time to hemostasis

    At the time of IUD insertion

  • Participant reported pain

    At the time of IUD insertion

Study Arms (2)

IUD placement with allis clamp

EXPERIMENTAL
Procedure: Allis clamp

IUD placement with single tooth tenaculum

ACTIVE COMPARATOR
Procedure: Single-tooth tenaculum

Interventions

Allis clampPROCEDURE

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

IUD placement with allis clamp
Single-tooth tenaculumPROCEDURE

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

IUD placement with single tooth tenaculum

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Obtaining IUD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Publications (1)

  • Andrews B, Quick K, MacLeod E, Edwards K, Rone BK. Cervical bleeding with cervical stabilization during IUD placement: allis clamp versus single-tooth tenaculum, a randomized control trial. Arch Gynecol Obstet. 2023 Apr;307(4):1015-1019. doi: 10.1007/s00404-022-06784-x. Epub 2022 Dec 7.

    PMID: 36477274DERIVED

Study Officials

  • Bryan Rone, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident Physician, OB/Gyn

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 11, 2022

Study Start

March 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)