Patient Satisfaction With the Management of a Stopped Pregnancy in the First Trimester

Pregnancy Loss, Early Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05049980
• Other study ID #: RC31/21/0328
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: February 14, 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 14, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Pregnancy Loss, Early

Intervention

Drug:
• Medical treatment with Mifégyne® and MisoOne®
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.

Procedure:
• Endo-uterine aspiration
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.

Locations

Country	Name	City	State
France	Mickael ALLOUCHE	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		Inclusion day (day 0)
Primary	Patient satisfaction	Completing the satisfaction questionnaire	Inclusion day (day 0)