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.
Miscarriage occurs in approximately 15% of pregnancies during the first trimester. In France, surgical management usually involves electric aspiration in the operating room under anesthesia, associated with hospital admission. Manual vacuum aspiration (MVA) is widely used in low-resource settings and for induced abortion, with demonstrated safety and patient satisfaction. This multicenter randomized controlled trial compares outpatient MVA under local anesthesia and inhaled analgesia versus electric aspiration (EA) under anesthesia in the operating room. The primary objective is to assess the incremental cost-utility ratio (ICUR, cost per QALY) at 3 months. Secondary outcomes include complications, pain, satisfaction, quality of life, and fertility at 12 months. The study anticipates enrolling 860 participants across multiple centers in France.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
860
Performed in consultation under local anesthesia and inhaled analgesia, using a manual vacuum aspirator and appropriate cannula. Post-procedure pelvic ultrasound to confirm complete evacuation.
Performed 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.
CHU de Nantes
Nantes, France
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.
Time frame: 3 months
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
Time frame: up to 5 years
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.
Time frame: 1 month
To assess patient satisfaction
To assess patient satisfaction: A numerical scale (NS) (0-10) on Days 1 and 2.
Time frame: day 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
Time frame: days 0, 1,7 and 1 and 3 months
The risk factors for failure
The risk factors for failure at M3 studied will be: the term of the terminated pregnancy, patient compliance, patient satisfaction (numerical scale (from 0 to 10), patient characteristics (age).
Time frame: 3 months
Satisfaction with the patient's care by medical staff
Satisfaction with the patient's care by medical staff will be assessed using an EN (numerical scale 0 to 10) at D0 and M1
Time frame: day 0 and 1 month
Patient having been pregnant in days
Patient having been pregnant at 12 months, pregnancy outcome and time to conception in days.
Time frame: 12 months
To assess patient satisfaction
To assess patient satisfaction: A numerical scale (NS) (0-10) on Days 1 and 2. HADS (Hospital Anxiety and Depression Scale) and PCL-5 questionnaires at 1 and 3 months
Time frame: day 1 and 2 and 1 month et 3 month
To assess patient satisfaction
HADS (Hospital Anxiety and Depression Scale) and PCL-5 questionnaires at 1 and 3 months
Time frame: 1 and 3 months
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
Time frame: Day 0, 1,7 and 1 and 3 months
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: ●Analgesic consumption (type, quantity, and duration) from Day 0 to 7
Time frame: Day 0 to 7
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: ●Number of pads used per day (Higham score) from Days 1 to 7
Time frame: Day 0 to 7
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: * Duration of the procedure in minutes * Waiting time for therapeutic treatment in minutes * Time spent in hospital in minutes
Time frame: Day 0
To compare the two strategies (electric suction versus manual vacuum kit suction)
To compare the two strategies (electric suction versus manual vacuum kit suction) ● Postoperative complications will include:Perioperative bleeding greater than 200 ml (Higham score), infection (temperature \>38°C and pelvic symptoms) …classified according to the Calvien and Dindo criteria, at M1, the persistence of abnormal bleeding, trophoblastic retention, at M3, the presence of amenorrhea outside the context of a new pregnancy
Time frame: 1 and 3 months
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: ●quality of life questionnaires EQ-5D-5L, PGI-I at M1 and M3
Time frame: 1 et 3 months
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