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

NCT ID: NCT06871618

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Retrospective

Intervention Type OTHER

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.

No interventions assigned to this group

Interventions

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Retrospective

Retrospective Operative risk in patients undergoing instrumental abortion

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Minor patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Croix Rousse University Hospital

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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24-5192

Identifier Type: -

Identifier Source: org_study_id

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