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Clinical Trials in France / NCT07732231
Starting soon Not applicable

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

NCT07732231 · tracked via the Priya Life Science France tracker
Sponsor
Nantes University Hospital
Phase
Not applicable
Started
2026-10-01
Last updated
2026-07-28

Condition(s) studied

MiscarriagePregnancy LossFirst Trimester Pregnancy

Investigational drug(s) / intervention(s)

Manual vacuum aspiration (MVA)Electric aspiration (EA)

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.

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.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
44 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
CHU de Nantes Nantes France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07732231 on ClinicalTrials.gov ↗ ← All trials in France