MiscarriageASPIRNCT07732231
Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage
A study testing Manual vacuum aspiration (MVA) and Electric aspiration (EA) in people with Miscarriage and Pregnancy Loss, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Miscarriage, Pregnancy Loss, First Trimester Pregnancy
- What is being tested?
- Manual vacuum aspiration (MVA) and Electric aspiration (EA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Nantes
Nantes, 44000
Thibault Thubert, Pr, +33 2 53 48 24 43, thibault.thubert@chu-nantes.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Miscarriage, Pregnancy Loss, First Trimester Pregnancy
- Being tested
- Manual vacuum aspiration (MVA), Electric aspiration (EA)
- Keywords
- Manual vacuum aspiration, Electric aspiration, Cost-effectiveness, Health economics, Gynecology, Pregnancy loss, miscarriage
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual vacuum aspiration (MVA)Procedure or surgery
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)Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Manual vacuum aspiration (MVA) | Experimental | Outpatient manual vacuum aspiration under local anesthesia and inhaled analgesia (MEOPA). Receives: Procedure: Manual vacuum aspiration (MVA) |
| Electric aspiration in the operating room under general or regional anesthesia. Electric aspiration | Active comparator | 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. Receives: Procedure: Electric aspiration (EA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental cost-utility ratio (ICUR)
Incremental cost per quality-adjusted life year (QALY) gained of outpatient MVA compared to operating room EA, from a collective perspective.
Measured: 3 months
Secondary outcomes (15)
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
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
Measured: up to 5 years
To compare the two management strategies in terms of success and intraoperative and postoperative complications
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.
Measured: 1 month
To assess patient satisfaction
To assess patient satisfaction:
A numerical scale (NS) (0-10) on Days 1 and 2.
Measured: day 1 and 2
To compare the two strategies (electric suction versus manual vacuum kit suction)
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
Measured: days 0, 1,7 and 1 and 3 months
The risk factors for failure
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).
Measured: 3 months
Satisfaction with the patient's care by medical staff
Satisfaction with the patient's care by medical staff will be assessed using an EN (numerical scale 0 to 10) at D0 and M1
Measured: day 0 and 1 month
Patient having been pregnant in days
Patient having been pregnant at 12 months, pregnancy outcome and time to conception in days.
Measured: 12 months
To assess patient satisfaction
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
Measured: day 1 and 2 and 1 month et 3 month
To assess patient satisfaction
HADS (Hospital Anxiety and Depression Scale) and PCL-5 questionnaires at 1 and 3 months
Measured: 1 and 3 months
To compare the two strategies (electric suction versus manual vacuum kit suction)
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
Measured: Day 0, 1,7 and 1 and 3 months
To compare the two strategies (electric suction versus manual vacuum kit suction)
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
Measured: Day 0 to 7
To compare the two strategies (electric suction versus manual vacuum kit suction)
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
Measured: Day 0 to 7
To compare the two strategies (electric suction versus manual vacuum kit suction)
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
Measured: Day 0
To compare the two strategies (electric suction versus manual vacuum kit suction)
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
Measured: 1 and 3 months
To compare the two strategies (electric suction versus manual vacuum kit suction)
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
Measured: 1 et 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibault Thubert, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732231
- Sponsor's protocol ID
- RC24_0471
- Other IDs
- 2025-A00724-45
- Acronym
- ASPIR
- Status last verified
- Jul 2026
- First submitted
- 28 May 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data may be shared upon reasonable request, subject to sponsor approval and compliance with French/EU data protection regulations (GDPR).
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage (ASPIR Study)
- ClinicalTrials.gov ID
- NCT07732231
- Acronym / sponsor ID
- ASPIR / RC24_0471
- Conditions
- Miscarriage, Pregnancy Loss, First Trimester Pregnancy
- Keywords
- Manual vacuum aspiration, Electric aspiration, Cost-effectiveness, Health economics, Gynecology, Pregnancy loss, miscarriage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual vacuum aspiration (MVA) | Experimental | Procedure: Manual vacuum aspiration (MVA)Outpatient manual vacuum aspiration under local anesthesia and inhaled analgesia (MEOPA). |
| Electric aspiration in the operating room under general or regional anesthesia. Electric aspiration | Active comparator | Procedure: Electric aspiration (EA)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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Manual vacuum aspiration (MVA) |
| 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. | Procedure or surgery | Electric aspiration in the operating room under general or regional anesthesia. Electric aspiration |
Primary outcome
Incremental cost-utility ratio (ICUR)
Time frame: 3 months
Incremental cost per quality-adjusted life year (QALY) gained of outpatient MVA compared to operating room EA, from a collective perspective.
15 secondary outcomes
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
To compare the two strategies (electric suction versus manual vacuum kit suction)
Time frame: Day 0
To compare the two strategies (electric suction versus manual vacuum kit suction)
Time frame: 1 and 3 months
To compare the two strategies (electric suction versus manual vacuum kit suction)
Time frame: 1 et 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data may be shared upon reasonable request, subject to sponsor approval and compliance with French/EU data protection regulations (GDPR).
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The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thibault Thubert, Pr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual vacuum aspiration (MVA) and Electric aspiration (EA) in people with Miscarriage and Pregnancy Loss, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thibault Thubert, Pr (+33253482443, thibault.thubert@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost-utility ratio (ICUR) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.