- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06396338
Voluntary Surgical Terminations of Pregnancy: Comparison of the Hemorrhagic Risk Depending on the Term (HEMOVG)
Voluntary Surgical Terminations of Pregnancy: Comparison of the Hemorrhagic Risk Depending on the Term, Between 10 and 14 Weeks of Amenorrhea or Between 14 and 16 Weeks of Amenorrhea
Voluntary termination of pregnancy (abortion) is a major current societal issue. This is a very common situation, around 225,000 abortions are carried out every year in France. The legislation has recently been amended, with the law of March 2, 2022 aimed at strengthening the right to abortion (no. 2022-295) which extended the legal period for voluntary termination of pregnancy from 14 to 16 weeks amenorrhea (AS).
The National College of French Obstetrician Gynecologists (CNGOF), in a press release published on October 12, 2020 in response to the proposed law adopted by the National Assembly, wishes to draw attention to the fact that the procedure of surgical abortion between 14 and 16 AS changes nature. He states that additional procedures are necessary beyond 14 weeks, which could be a source of complications. In addition, the practice recommendations have not been updated following this extension of time, the centers performing abortions are therefore free regarding the protocol for carrying out these so-called late abortions (between 14 and 16 weeks).
There are two pregnancy termination techniques practiced in France: medical or surgical.
Due to the recent nature of these late abortions, practitioners still have little experience of the consequences of these procedures and this compromises the quality of the information provided to patients. It is necessary to have quality studies to improve knowledge about late-term abortions, in order to be able to correctly inform patients and allow them to make an informed choice regarding the method used.
This study follows the modification of the legislation extending the legal period for abortion, with the aim of providing arguments regarding the safety of carrying out surgical abortions at these more advanced stages of pregnancy.
In addition, abortion often generates anxiety, the term at which it is carried out could influence the experience of patients. This study would therefore also improve knowledge about the experience of abortion, in order to better support patients throughout their journey.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Toulouse, France
- Chu Toulouse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Woman treated for the performance of a surgical abortion between 10 and 16 weeks (dating by ultrasound)
- Singleton pregnancy
Exclusion Criteria:
- Protected adult patient (guardianship, curatorship, safeguard of justice)
- Refusal to participate expressed by the patient
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Experimental: Patient treated at the Toulouse University Hospital for an abortion
Patient treated at the Toulouse University Hospital for an abortion between 10 and 16 weeks (dating by ultrasound) presenting with a single and evolving pregnancy
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A questionnaire is offered to patients who meet the eligibility criteria and who have given their non-objection during the abortion request consultation. This questionnaire includes questions for screening for anxiety and depressive disorders. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of anxiety or depressive disorder
Time Frame: 3 weeks after abortion
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Anxiety will be measured using State-Trait Anxiety Inventory (STAI) Scale
|
3 weeks after abortion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lola LOUSSERT-CHAMBRE, MD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/24/0167
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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