Clinical trial NCT06871618: Retrospective Study of Surgical Induced Abortions Between 14 and 16 Weeks of Amenorrhea At Croix Rousse University Hospital in Lyon
Official title: Retrospective Study of Surgical Induced Abortions Between 14 and 16 Weeks of Amenorrhea At Croix Rousse University Hospital in Lyon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Induced Abortion
Instrumental Induced Abortion Between 14 and 16 Weeks of Amenorrhea
Keywords: interruption of pregnancy
Induced abortion
instrumental technique
women complications
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: Eligibility Criteria \*

* Inclusion Criteria \* :

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

  * Minor patients

Primary outcomes:
measure: Proportion of patients with intraoperative bleeding > 500 mL
timeFrame: Primary endpoint is measured during the intervention by collecting the total blood quantity collected into a reservoir connected to the aspiration probe.
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix Rousse University Hospital
Study officials:
References: