IUD Clinical Trial
Official title:
Cervical Bleeding With Cervical Stabilization During IUD Placement: Allis Clamp Versus Single-tooth Tenaculum
NCT number | NCT05187078 |
Other study ID # | 16-1110-P3K |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2017 |
Est. completion date | March 1, 2018 |
Verified date | December 2021 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to determine whether an Allis clamp is an effective clamp for cervical stabilization compared to a single-tooth tenaculum.
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: - |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Brooke Andrews |
United States,
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 |
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