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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Pregnancy Loss, Early

Intervention / Treatment
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* Drug: Medical treatment with Mifégyne® and MisoOne®
* Procedure: Endo-uterine aspiration


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical treatment<br>Patients choosing medical treatment with Mifégyne® and MisoOne® | Drug: Medical treatment with Mifégyne® and MisoOne®<br>* 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.<br>|
| Active Comparator: Surgical treatment<br>Patients choosing surgical treatment by endo-uterine aspiration. | Procedure: Endo-uterine aspiration<br>* 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.<br>|

What is the study measuring?
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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) |