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
Overview
- Phase
- Not Applicable
- Intervention
- Medical treatment with Mifégyne® and MisoOne®
- Conditions
- Pregnancy Loss, Early
- Sponsor
- University Hospital, Toulouse
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
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)
Arms & Interventions
Medical treatment
Patients choosing medical treatment with Mifégyne® and MisoOne®
Intervention: Medical treatment with Mifégyne® and MisoOne®
Surgical treatment
Patients choosing surgical treatment by endo-uterine aspiration.
Intervention: Endo-uterine aspiration
Outcomes
Primary Outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Inclusion day (day 0)
Patient satisfaction
Time Frame: Inclusion day (day 0)
Completing the satisfaction questionnaire