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

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Civil Hospices of Lyon

Status

Completed

Conditions

Induced Abortion
Instrumental Induced Abortion Between 14 and 16 Weeks of Amenorrhea

Treatments

Other: Retrospective

Study type

Observational

Funder types

Other

Identifiers

NCT06871618
24-5192

Details and patient eligibility

About

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.

Enrollment

700 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria *

  • Inclusion Criteria * :

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

    • Minor patients

Trial design

700 participants in 2 patient groups

Women who undergone a surgical induced abortion before 14AW
Description:
Women who undergone a surgical induced abortion at Croix Rousse Hospital in Lyon between March 2022 and March 2023 before 14AW
Treatment:
Other: Retrospective
Women who undergone a surgical induced abortion between 14 and 16AW.
Description:
Women who undergone a surgical induced abortion at Croix Rousse Hospital in Lyon between March 2022 and March 2023 between 14 and 16AW.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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