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Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage (ASPIR)

27 juli 2026 bijgewerkt door: Nantes University Hospital

Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage (ASPIR Study)

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

860

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Manual vacuum aspiration (MVA)
Outpatient manual vacuum aspiration under local anesthesia and inhaled analgesia (MEOPA).
Procedure: Manual vacuum aspiration (MVA)
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.
Actieve vergelijker: 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.
Procedure: Electric aspiration (EA)
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incremental cost-utility ratio (ICUR)
Tijdsspanne: 3 months
Incremental cost per quality-adjusted life year (QALY) gained of outpatient MVA compared to operating room EA, from a collective perspective.
3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: up to 5 years
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
up to 5 years
To compare the two management strategies in terms of success and intraoperative and postoperative complications
Tijdsspanne: 1 month

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.
1 month
To assess patient satisfaction
Tijdsspanne: day 1 and 2

To assess patient satisfaction:

A numerical scale (NS) (0-10) on Days 1 and 2.
day 1 and 2
To compare the two strategies (electric suction versus manual vacuum kit suction)
Tijdsspanne: days 0, 1,7 and 1 and 3 months

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
The risk factors for failure
Tijdsspanne: 3 months
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).
3 months
Satisfaction with the patient's care by medical staff
Tijdsspanne: day 0 and 1 month
Satisfaction with the patient's care by medical staff will be assessed using an EN (numerical scale 0 to 10) at D0 and M1
day 0 and 1 month
Patient having been pregnant in days
Tijdsspanne: 12 months
Patient having been pregnant at 12 months, pregnancy outcome and time to conception in days.
12 months
To assess patient satisfaction
Tijdsspanne: day 1 and 2 and 1 month et 3 month

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
To assess patient satisfaction
Tijdsspanne: 1 and 3 months
HADS (Hospital Anxiety and Depression Scale) and PCL-5 questionnaires at 1 and 3 months
1 and 3 months
To compare the two strategies (electric suction versus manual vacuum kit suction)
Tijdsspanne: Day 0, 1,7 and 1 and 3 months

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
To compare the two strategies (electric suction versus manual vacuum kit suction)
Tijdsspanne: Day 0 to 7

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
To compare the two strategies (electric suction versus manual vacuum kit suction)
Tijdsspanne: Day 0 to 7

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
To compare the two strategies (electric suction versus manual vacuum kit suction)
Tijdsspanne: Day 0

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
Day 0
To compare the two strategies (electric suction versus manual vacuum kit suction)
Tijdsspanne: 1 and 3 months

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
To compare the two strategies (electric suction versus manual vacuum kit suction)
Tijdsspanne: 1 et 3 months

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nantes University Hospital

Onderzoekers

  • Hoofdonderzoeker: Thibault Thubert, Pr, Nantes university hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 januari 2027

Studie voltooiing (Geschat)

1 oktober 2029

Studieregistratiedata

Eerst ingediend

28 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 juli 2026

Eerst geplaatst (Werkelijk)

28 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

27 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RC24_0471
  • 2025-A00724-45 (Andere identificatie: ANSM)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

Individual participant data may be shared upon reasonable request, subject to sponsor approval and compliance with French/EU data protection regulations (GDPR).

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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