Patient Satisfaction With the Management of a Stopped Pregnancy in the First Trimester (MYFEFACY)
Primary Purpose
Pregnancy Loss, Early
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Medical treatment with Mifégyne® and MisoOne®
Endo-uterine aspiration
Sponsored by
About this trial
This is an interventional other trial for Pregnancy Loss, Early
Eligibility Criteria
Inclusion Criteria:
- Any adult patient presenting to the gynecological emergency department of the Paule de Viguier Hospital in Toulouse for whom a diagnosis of an arrested pregnancy in the first trimester is made
- Whose cranio-caudal length of the embryo measured by ultrasound is less than 25 mm or having a clear egg
- Having agreed to the study (written or verbal) after clear and fair information
- Who understands and reads French
Exclusion Criteria:
- Medical contraindication to treatment with Mifégyne® or MisoOne®
- Hemodynamically unstable patient requiring urgent surgical treatment.
- Protected adult patient (guardianship, curatorship, safeguard of justice)
Sites / Locations
- Mickael ALLOUCHE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Medical treatment
Surgical treatment
Arm Description
Patients choosing medical treatment with Mifégyne® and MisoOne®
Patients choosing surgical treatment by endo-uterine aspiration.
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Patient satisfaction
Completing the satisfaction questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT05049980
First Posted
August 26, 2021
Last Updated
March 11, 2022
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT05049980
Brief Title
Patient Satisfaction With the Management of a Stopped Pregnancy in the First Trimester
Acronym
MYFEFACY
Official Title
Evaluation of the Efficacy, Tolerance of the Treatment, and Patient Satisfaction During the Management of an Arrested Pregnancy in the First Trimester According to the New Toulouse University Hospital Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
February 14, 2022 (Actual)
Study Completion Date
February 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The clinical practice recommendations highlight the fact that the patient's choice concerning the management of her aborted pregnancy in the first trimester should be privileged, after clear and appropriate information on the available treatments, in order to improve his experience and reduce the negative psychological symptoms that can generate an alteration in the quality of life, in the aftermath of the loss of pregnancy.
The present study will describe the efficacy, satisfaction and tolerance of patients benefiting from medical treatment with Mifégyne® and MisoOne® versus those benefiting from surgical treatment by endo-uterine aspiration for the management of a pregnancy stopped during the first trimester at the Toulouse University Hospital
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Loss, Early
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical treatment
Arm Type
Experimental
Arm Description
Patients choosing medical treatment with Mifégyne® and MisoOne®
Arm Title
Surgical treatment
Arm Type
Active Comparator
Arm Description
Patients choosing surgical treatment by endo-uterine aspiration.
Intervention Type
Drug
Intervention Name(s)
Medical treatment with Mifégyne® and MisoOne®
Intervention Description
When participants arrive for their uterine emptiness check-up, 12 days after treatment, patients will be asked to drop off the study questionnaire the same day in a box provided for this purpose in the department.
Intervention Type
Procedure
Intervention Name(s)
Endo-uterine aspiration
Intervention Description
When patients arrive in hospital on the day of the surgery, participants will be asked to complete a questionnaire at home 1 week after surgery and return it to investigators.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Inclusion day (day 0)
Title
Patient satisfaction
Description
Completing the satisfaction questionnaire
Time Frame
Inclusion day (day 0)
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any adult patient presenting to the gynecological emergency department of the Paule de Viguier Hospital in Toulouse for whom a diagnosis of an arrested pregnancy in the first trimester is made
Whose cranio-caudal length of the embryo measured by ultrasound is less than 25 mm or having a clear egg
Having agreed to the study (written or verbal) after clear and fair information
Who understands and reads French
Exclusion Criteria:
Medical contraindication to treatment with Mifégyne® or MisoOne®
Hemodynamically unstable patient requiring urgent surgical treatment.
Protected adult patient (guardianship, curatorship, safeguard of justice)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mickael ALLOUCHE, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mickael ALLOUCHE
City
Toulouse
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Satisfaction With the Management of a Stopped Pregnancy in the First Trimester
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