NCT05932537

Brief Summary

The ablation of subcutaneous contraceptive implants is usually performed in consultation under local anesthesia. However, it happens that the implant was placed too deeply or that it migrated too deeply making it impossible to remove it in consultation. These patients should then be referred to reference centers so that the explantation takes place in the operating room. The investigators propose to describe their techniques for preoperative visualization of the implant and their techniques for surgical explantation for educational purposes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

September 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 13, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

December 14, 2022

Last Update Submit

November 9, 2023

Conditions

Contraceptive Usage

Keywords

subcutaneous contraceptive implantsablationoperating room

Outcome Measures

Primary Outcomes (1)

  • Ultrasound for visualization of implants

    Percentage of patients with an ultrasound to visualize the implants

    preoperatively

Study Arms (1)

subcutaneous contraceptive implants

patients who have benefited from explantation of a subcutaneous contraceptive implant in the gynecology operating room

Procedure: Preoperative visualization techniques

Interventions

Preoperative visualization techniquesPROCEDURE

describe techniques for pre-operative visualization of subcutaneous contraceptive implants

subcutaneous contraceptive implants

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study covers all patients who underwent explantation of a subcutaneous contraceptive implant in the gynecology operating room of the Hôpital Femme Mère Enfant, between 2018 and 2022.

You may qualify if:

  • women over 18
  • patient who underwent explantation of a subcutaneous contraceptive implant in the gynecology operating room
  • intervention between 2018 and 2022
  • person having expressed his non-opposition

You may not qualify if:

  • explantation outside the operating room
  • inability to understand the information given
  • person deprived of liberty
  • person under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

Bron, 69677, France

RECRUITING

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2022

First Posted

July 6, 2023

Study Start

September 15, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

November 13, 2023

Record last verified: 2023-07

Locations

FR(1)