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NCT06871618: TARDIVG
Retrospective Study of Surgical Induced Abortions Between 14 and 16 Weeks of Amenorrhea At Croix Rousse University Hospital in Lyon
trial testing Retrospective in Induced Abortion in 700 participants. Completed in 1 September 2024.
1 July 2024
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 700 |
| Start date | 1 April 2024 |
| Primary completion | 1 July 2024 |
| Estimated completion | 1 September 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- Retrospective
Conditions studied
- Induced Abortion — all drugs for Induced Abortion →
- Instrumental Induced Abortion Between 14 and 16 Weeks of Amenorrhea — all drugs for Instrumental Induced Abortion Between 14 and 16 Weeks of Amenorrhea →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
Adults 18 to 50, female only, with Induced Abortion or Instrumental Induced Abortion Between 14 and 16 Weeks of Amenorrhea. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06871618
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06871618 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 12 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06871618.
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