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

Not Applicable

Completed

• Conditions: Pregnancy Loss, Early
• Interventions: Drug: Medical treatment with Mifégyne® and MisoOne®; Procedure: Endo-uterine aspiration

• Registration Number: NCT05049980
• Lead Sponsor: University Hospital, Toulouse

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-20
• Study Start: 2021-11-01
• Primary Completion: 2022-02-14
• Study Completion: 2022-02-14
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-11
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical treatment	Medical treatment with Mifégyne® and MisoOne®	Patients choosing medical treatment with Mifégyne® and MisoOne®
Surgical treatment	Endo-uterine aspiration	Patients choosing surgical treatment by endo-uterine aspiration.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mickael ALLOUCHE; 🇫🇷 Toulouse, France