NCT05645614

Brief Summary

The aim of the study is to retrospectively analyze pain and anxiety assessment data previously collected in routine care in women who had an abortion under local anesthesia in order to identify the predictive factors of pain and anxiety, as well as to compare the results with previously published data. The participants are women who underwent abortion under local anesthesia in the gynecology department of the Pitié Salpêtrière Hospital between May and October 2021.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 9, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

December 1, 2022

Last Update Submit

February 28, 2023

Conditions

Abortion

Outcome Measures

Primary Outcomes (1)

  • Pain level of the patient before, during and after (10min post surgery) the abortion procedure under local anesthesia.

    Evolution of pain over time (from preoperative to postoperative), self-assessed on a numerical scale from 0 to 10

    3 hours

Secondary Outcomes (1)

  • Anxiety level of the patient before, during and after (10min post surgery) the abortion procedure under local anesthesia.

    3 hours

Interventions

EVALUATION OF PAINOTHER

PAIN EVALUATION THANKS TO SCALES

Eligibility Criteria

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

patients who had an abortion under local anesthesia

You may qualify if:

  • patients who need an abortion under local anesthesia
  • Women who speak and read French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Pitié Salpetrière

Paris, 75013, France

RECRUITING

Central Study Contacts

Salignon Alexandra, MD

CONTACT

142165762louise-laure.mariani@aphp.fr

Mariani Louise Laure, MD,PH

CONTACT

142165762louise-laure.mariani@aphp.fr

Study Design

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

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 9, 2022

Study Start

December 9, 2022

Primary Completion

June 15, 2023

Study Completion

June 15, 2023

Last Updated

March 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)