Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Manual vacuum aspiration (MVA), Electric aspiration (EA).
- Who it may be relevant to
- Registry conditions: Miscarriage, Pregnancy Loss, First Trimester Pregnancy. Basic parameters: 18 years — 44 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage (ASPIR Study)
Overview
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.
Detailed description
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.
Interventions
- 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. - 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.
Primary outcome measures
- Incremental cost-utility ratio (ICUR) [Time frame: 3 months]
Secondary outcome measures (12)
- 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 [Time frame: 1 month]
- To assess patient satisfaction [Time frame: day 1 and 2]
- To compare the two strategies (electric suction versus manual vacuum kit suction) [Time frame: days 0, 1,7 and 1 and 3 months]
- The risk factors for failure [Time frame: 3 months]
- Satisfaction with the patient's care by medical staff [Time frame: day 0 and 1 month]
- Patient having been pregnant in days [Time frame: 12 months]
- To assess patient satisfaction [Time frame: day 1 and 2 and 1 month et 3 month]
- To assess patient satisfaction [Time frame: 1 and 3 months]
- To compare the two strategies (electric suction versus manual vacuum kit suction) [Time frame: Day 0, 1,7 and 1 and 3 months]
- To compare the two strategies (electric suction versus manual vacuum kit suction) [Time frame: Day 0 to 7]
- To compare the two strategies (electric suction versus manual vacuum kit suction) [Time frame: Day 0 to 7]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 1 center
- CHU de Nantes — Nantes
Identifiers
NCT: NCT07732231 · RC24_0471 · 2025-A00724-45