IUDNCT05187078
Allis Clamp Versus Single-tooth Tenaculum
A study testing Allis clamp and Single-tooth tenaculum in people with IUD, run by Brooke Andrews at 1 site in United States.
Trial summary
This study aims to determine whether an Allis clamp is an effective clamp for cervical stabilization compared to a single-tooth tenaculum. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD
- What is being tested?
- Allis clamp and Single-tooth tenaculum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obtaining IUD
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cervical Bleeding With Cervical Stabilization During IUD Placement: 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.
- Conditions
- IUD
- Being tested
- Allis clamp, Single-tooth tenaculum
- Keywords
- Cervical stabilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allis clampProcedure or surgery
Physicians utilized an Allis clam for cervical stabilization during IUD placement.
Single-tooth tenaculumProcedure or surgery
Physicians utilized a single-tooth tenaculum clam for cervical stabilization during IUD placement.
| Study group | Role | What they receive |
|---|---|---|
| IUD placement with allis clamp | Experimental | Not described Receives: Procedure: Allis clamp |
| IUD placement with single tooth tenaculum | Active comparator | Not described Receives: Procedure: Single-tooth tenaculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of IUD insertion
Secondary outcomes (4)
IUD insertion success rate
The percentage of participants who successfully had an IUD placed with an Allis clamp or single-tooth tenaculum.
Measured: At the time of IUD insertion
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.
Measured: At the time of IUD insertion
Time to hemostasis
The time in seconds required to achieve hemostasis after IUD placement with an Allis clamp or single-tooth tenaculum.
Measured: At the time of IUD insertion
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.
Measured: At the time of IUD insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Mar 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IUDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Andrews
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brooke Andrews, University of Kentucky
- Investigators
- Bryan Rone, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187078
- Sponsor's protocol ID
- 16-1110-P3K
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36477274
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Bleeding With Cervical Stabilization During IUD Placement: Allis Clamp Versus Single-tooth Tenaculum
- ClinicalTrials.gov ID
- NCT05187078
- Acronym / sponsor ID
- 16-1110-P3K
- Conditions
- IUD
- Keywords
- Cervical stabilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Brooke AndrewsUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine whether an Allis clamp is an effective clamp for cervical stabilization compared to a single-tooth tenaculum.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IUD placement with allis clamp | Experimental | Procedure: Allis clamp |
| IUD placement with single tooth tenaculum | Active comparator | Procedure: Single-tooth tenaculum |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Obtaining IUD
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allis clampPhysicians utilized an Allis clam for cervical stabilization during IUD placement. | Procedure or surgery | IUD placement with allis clamp |
| Single-tooth tenaculumPhysicians utilized a single-tooth tenaculum clam for cervical stabilization during IUD placement. | Procedure or surgery | IUD placement with single tooth tenaculum |
Primary outcome
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.
4 secondary outcomes
IUD insertion success rate
Time frame: At the time of IUD insertion
Number of interventions required for cervical clamp site bleeding hemostasis
Time frame: At the time of IUD insertion
Time to hemostasis
Time frame: At the time of IUD insertion
Participant reported pain
Time frame: At the time of IUD insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 36477274Andrews 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Rone, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allis clamp and Single-tooth tenaculum in people with IUD, run by Brooke Andrews at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who experienced bleeding after IUD placement (time frame: At the time of IUD insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05187078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.