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

NCT ID: NCT05049980

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-02-14

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

Conditions

Pregnancy Loss, Early

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Medical treatment

Patients choosing medical treatment with Mifégyne® and MisoOne®

Group Type: EXPERIMENTAL

Medical treatment with Mifégyne® and MisoOne®

Intervention Type: DRUG

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.

Surgical treatment

Patients choosing surgical treatment by endo-uterine aspiration.

Group Type: ACTIVE_COMPARATOR

Endo-uterine aspiration

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mickael ALLOUCHE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Mickael ALLOUCHE

Toulouse, , France

Countries

France

Other Identifiers

RC31/21/0328

Identifier Type: -

Identifier Source: org_study_id