Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage (ASPIR)
Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage (ASPIR Study)
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Thibault Thubert, Pr
- Numer telefonu: +33253482443
- E-mail: thibault.thubert@chu-nantes.fr
Lokalizacje studiów
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Nantes, Francja, 44000
- CHU de Nantes
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Kontakt:
- Thibault Thubert, Pr
- Numer telefonu: +33 2 53 48 24 43
- E-mail: thibault.thubert@chu-nantes.fr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- 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
- Patient able to provide oral informed consent
Exclusion Criteria:
- Complete expulsion of pregnancy (endometrial thickness < 15 mm)
- Choice of medical treatment with misoprostol
- Elective termination of pregnancy
- Unwanted pregnancy
- Pregnancy of unknown location, molar pregnancy
- Known uterine malformation
- Prior surgical aspiration for the current pregnancy
- Intrauterine device in place
- Contraindicating medications (e.g. anticoagulants)
- Protected adults (under guardianship)
- Inability to complete study questionnaires
- Lack of social security coverage
- Haemorrhagic miscarriage
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Manual vacuum aspiration (MVA)
Outpatient manual vacuum aspiration under local anesthesia and inhaled analgesia (MEOPA).
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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.
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Aktywny komparator: Electric aspiration in the operating room under general or regional anesthesia. Electric aspiration
Electric aspiration in the operating room under general or regional anesthesia.
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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Incremental cost-utility ratio (ICUR)
Ramy czasowe: 3 months
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Incremental cost per quality-adjusted life year (QALY) gained of outpatient MVA compared to operating room EA, from a collective perspective.
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3 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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
Ramy czasowe: up to 5 years
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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
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up to 5 years
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To compare the two management strategies in terms of success and intraoperative and postoperative complications
Ramy czasowe: 1 month
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To compare the two management strategies in terms of success and intraoperative and postoperative complications
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1 month
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To assess patient satisfaction
Ramy czasowe: day 1 and 2
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To assess patient satisfaction: A numerical scale (NS) (0-10) on Days 1 and 2. |
day 1 and 2
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To compare the two strategies (electric suction versus manual vacuum kit suction)
Ramy czasowe: days 0, 1,7 and 1 and 3 months
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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 |
days 0, 1,7 and 1 and 3 months
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The risk factors for failure
Ramy czasowe: 3 months
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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).
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3 months
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Satisfaction with the patient's care by medical staff
Ramy czasowe: day 0 and 1 month
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Satisfaction with the patient's care by medical staff will be assessed using an EN (numerical scale 0 to 10) at D0 and M1
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day 0 and 1 month
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Patient having been pregnant in days
Ramy czasowe: 12 months
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Patient having been pregnant at 12 months, pregnancy outcome and time to conception in days.
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12 months
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To assess patient satisfaction
Ramy czasowe: day 1 and 2 and 1 month et 3 month
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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 |
day 1 and 2 and 1 month et 3 month
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To assess patient satisfaction
Ramy czasowe: 1 and 3 months
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HADS (Hospital Anxiety and Depression Scale) and PCL-5 questionnaires at 1 and 3 months
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1 and 3 months
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To compare the two strategies (electric suction versus manual vacuum kit suction)
Ramy czasowe: Day 0, 1,7 and 1 and 3 months
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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 |
Day 0, 1,7 and 1 and 3 months
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To compare the two strategies (electric suction versus manual vacuum kit suction)
Ramy czasowe: Day 0 to 7
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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 |
Day 0 to 7
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To compare the two strategies (electric suction versus manual vacuum kit suction)
Ramy czasowe: Day 0 to 7
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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 |
Day 0 to 7
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To compare the two strategies (electric suction versus manual vacuum kit suction)
Ramy czasowe: Day 0
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To compare the two strategies (electric suction versus manual vacuum kit suction), measurement of:
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Day 0
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To compare the two strategies (electric suction versus manual vacuum kit suction)
Ramy czasowe: 1 and 3 months
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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 |
1 and 3 months
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To compare the two strategies (electric suction versus manual vacuum kit suction)
Ramy czasowe: 1 et 3 months
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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 |
1 et 3 months
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Thibault Thubert, Pr, Nantes university hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- RC24_0471
- 2025-A00724-45 (Inny identyfikator: ANSM)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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