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

NCT05049980 | Completed

• 1 other identifier: RC31/21/0328
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Medical treatment

EXPERIMENTAL

Patients choosing medical treatment with Mifégyne® and MisoOne®

Drug: Medical treatment with Mifégyne® and MisoOne®

Surgical treatment

ACTIVE COMPARATOR

Patients choosing surgical treatment by endo-uterine aspiration.

Procedure: Endo-uterine aspiration

Interventions

Medical treatment with Mifégyne® and MisoOne® 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.

Medical treatment

Endo-uterine aspiration 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.

Surgical treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medical contraindication to treatment with Mifégyne® or MisoOne®
• Hemodynamically unstable patient requiring urgent surgical treatment.
• Protected adult patient (guardianship, curatorship, safeguard of justice)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Mickael ALLOUCHE

Toulouse, France

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mickael ALLOUCHE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 20, 2021
• Study Start: November 1, 2021
• Primary Completion: February 14, 2022
• Study Completion: February 14, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)