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

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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Loss, Early
• Intervention / Treatment: Drug: Medical treatment with Mifégyne® and MisoOne®; Procedure: Endo-uterine aspiration

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • Mickael ALLOUCHE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical treatment; Patients choosing medical treatment with Mifégyne® and MisoOne®	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.
Active Comparator: Surgical treatment; Patients choosing surgical treatment by endo-uterine aspiration.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Mickael ALLOUCHE, MD, CHU Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): February 14, 2022
• Study Completion (Actual): February 14, 2022

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Mifepristone
• Other Study ID Numbers: RC31/21/0328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No