Retrospective Study of Surgical Induced Abortions Between 14 and 16 Weeks of Amenorrhea At Croix Rousse University Hospital in Lyon (TARDIVG)

March 6, 2025 updated by: Hospices Civils de Lyon

In France, induced abortions can be carried out by two different methods: the medicinal one, which involves taking medications to expel the pregnancy (MIFEPRISTONE and then MISOPROSTOL), and the instrumental one, which involves aspiration in the operating room.

According to the high authority of health, before 9 weeks of amenorrhea, both methods are possible if there is no contraindication to one of them. After 9 weeks of amenorrhea, only the instrumental method is authorized.

Until March 2022, the maximal deadline to abort was 14 weeks of amenorrhea. On March 2nd 2022, a change in the law extended this time limit from 14 to 16 weeks of amenorrhea. Only one study was carried out following this change in France to assess the complication rate of late abortions (between 14 and 16 weeks of amenorrhea (AW)). This study was carried out at Trousseau Hospital in Paris, with a total of 46 patients. The results of this study were reassuring, with bleeding > 500 mL for only one patient (2.2%, 95% CI [0.0-6.4]) and no complications such as perforation, postoperative infection or revision surgery, or need for transfusion.

However, this paper is the only French study which evaluated the operative risks of late abortion since the change in the law, and its power is small. There is a need to assess the operative risks of late abortion on a larger cohort.

That's why the investigators had the idea to conduct a study looking at all instrumental abortions performed in Croix Rousse Hospital in Lyon between March 2022 and March 2023, representing around 700 procedures. The aim of the study is to compare the complication rates of instrumental abortions between 14 and 16 weeks of amenorrhea versus those carried out before 14 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • Croix Rousse University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult women who undergone a surgical abortion at Croix Rousse Hospital in Lyon between March 2022 and March 2023.

Description

Eligibility Criteria *

  • Inclusion Criteria * :

    • Surgical induced abortion
    • At Croix Rousse hospital, Lyon
    • Between March 2022 and March 2023

  • Exclusion Criteria * :

    • Minor patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women who undergone a surgical induced abortion before 14AW
Women who undergone a surgical induced abortion at Croix Rousse Hospital in Lyon between March 2022 and March 2023 before 14AW
Other: Retrospective
Retrospective Operative risk in patients undergoing instrumental abortion
Women who undergone a surgical induced abortion between 14 and 16AW.
Women who undergone a surgical induced abortion at Croix Rousse Hospital in Lyon between March 2022 and March 2023 between 14 and 16AW.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with intraoperative bleeding > 500 mL
Time Frame: Primary endpoint is measured during the intervention by collecting the total blood quantity collected into a reservoir connected to the aspiration probe.
Evaluated by collecting blood loss during the procedure (in 50 mL increments)
Primary endpoint is measured during the intervention by collecting the total blood quantity collected into a reservoir connected to the aspiration probe.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-5192

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Subscribe