Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

27. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

860

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Manual vacuum aspiration (MVA)
Outpatient manual vacuum aspiration under local anesthesia and inhaled analgesia (MEOPA).
Verfahren: 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.
Aktiver 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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incremental cost-utility ratio (ICUR)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 12 months
Patient having been pregnant at 12 months, pregnancy outcome and time to conception in days.
12 months
To assess patient satisfaction
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Nantes University Hospital

Ermittler

  • Hauptermittler: Thibault Thubert, Pr, Nantes university hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Oktober 2029

Studienanmeldedaten

Zuerst eingereicht

28. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Juli 2026

Zuerst gepostet (Tatsächlich)

28. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren