The ASPIR study aims to evaluate the cost-utility of outpatient manual vacuum aspiration compared with operating room electric aspiration for the management of first-trimester miscarriage. It is hypothesized that manual aspiration will demonstrate equivalent clinical efficacy and patient quality of life while reducing healthcare costs.
Female, aged 18-44 years
Ultrasound-confirmed first-trimester miscarriage requiring surgical management
Gestational age between 5 and 12 weeks of amenorrhea
Incomplete spontaneous abortion or ongoing non-viable pregnancy
Complete expulsion of pregnancy (endometrial thickness < 15 mm)
Choice of medical treatment with misoprostol
Elective termination of pregnancy
Unwanted pregnancy
Parallel
Manual vacuum aspiration (MVA)
Procedure/SurgeryPerformed in consultation under local anesthesia and inhaled analgesia, using a manual vacuum aspirator and appropriate cannula. Post-procedure pelvic ultrasound to confirm complete evacuation.
Electric aspiration (EA)
Procedure/SurgeryPerformed in the operating room under general or regional anesthesia, using an electric suction device and appropriate cannula. Post-procedure pelvic ultrasound to confirm complete evacuation.
Incremental cost-utility ratio (ICUR)
Incremental cost per quality-adjusted life year (QALY) gained of outpatient MVA compared to operating room EA, from a collective perspective.
Annual net financial benefit for health insurance over up to 5 years of different development scenarios for manual vacuum aspiration in consultation for the management of pregnancies terminated before 12 weeks of gestation
Annual net financial benefit for health insurance over up to 5 years of different development scenarios for manual vacuum aspiration in consultation for the management of pregnancies terminated before 12 weeks of gestation
To compare the two management strategies in terms of success and intraoperative and postoperative complications
To compare the two management strategies in terms of success and intraoperative and postoperative complications * 2.1 Management failure defined by the need for second-line treatment (aspiration, misoprostol, etc.) * 2.2 Intraoperative complications: change of strategy, bleeding greater than 200 ml, uterine perforation, etc., and all possible complications classified according to the Clavien and Dindo criteria * 2.3 Trophoblastic retention image defined by retention (heterogeneous intrauterine mass independent of the endometrium) greater than 20 mm thick on transvaginal ultrasound at M1.
To assess patient satisfaction
To assess patient satisfaction: A numerical scale (NS) (0-10) on Days 1 and 2.
To compare the two strategies (electric suction versus manual vacuum kit suction)
To compare the two strategies (electric suction versus manual vacuum kit suction), measurement of: ●Pain via NS (a scale from 0 to 10) on Day 0 (before the procedure, 30 min after the procedure +/- 30 min), Days 1, 7, 1, and 3
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
