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Completed

NCT Number: NCT06871618

Retrospective Study of Surgical Induced Abortions Between 14 and 16 Weeks of Amenorrhea At Croix Rousse University Hospital in 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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Croix Rousse University Hospital

Lyon, France

Who can participate

Healthy volunteers accepted: No

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

Eligibility Criteria *

  • Inclusion Criteria * :
  • Surgical induced abortion
  • At Croix Rousse hospital, Lyon
  • Between March 2022 and March 2023
  • Exclusion Criteria * :
  • Minor patients

Treatment and study plan

retrospective

Other

Retrospective Operative risk in patients undergoing instrumental abortion

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: TARDIVG

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

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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