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OpenTrials
Completed

NCT Number: NCT05049980

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

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

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Key information

Conditions

Pregnancy Loss, Early Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mickael ALLOUCHE

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: Inclusion day (day 0)

  2. Patient satisfaction

    Time frame: Inclusion day (day 0)

    Completing the satisfaction questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: MYFEFACY

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 20, 2021
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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