An interventional study of Manual vacuum aspiration (MVA) and Electric aspiration (EA) in Miscarriage, Pregnancy Loss and First Trimester Pregnancy, sponsored by Nantes University Hospital. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Health services research
Among 27 studies in Abortion, Spontaneous with a site in France — 7 open to participants now, 8 under way, none of them phase 3. Abortion, Spontaneous · France.
Among the 27 studies in Abortion, Spontaneous with a site in France, this one is the 2nd largest by planned enrollment of the 14 interventional ones, is one of 2 that started in 2026, is one of 12 with no phase, and was the 26th registered.
221 studies on the registry are indexed under Abortion, Spontaneous; 44 are open to participants now.
This study's planned enrollment of 860 is above the median of 150 across 120 interventional studies indexed under Abortion, Spontaneous.
Browse Abortion, Spontaneous studies →7 of the 27 studies in Abortion, Spontaneous with a site in France are open now, in 1 country. Each count lists the studies.
Of the 36 Abortion, Spontaneous studies recruiting now, 11 (31%) set no upper age limit and 25 (69%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 44 Years · female · no healthy volunteers.
The full table on the hub →27 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 2 started in 2026.
Median enrollment 210 across the 14 interventional studies, 202 across the 13 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
3 of 27 have an industry lead sponsor. The 10 most frequent:
Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Nantes University Hospital has 1 study filed under Abortion, Spontaneous — fewer than ten, so there is no comparison to draw.
5 of the studies in Abortion, Spontaneous with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06576622University Hospital, ToulousePERIodontal Disease, Microbiota and Miscarriage | 2026-12-30 |
| NCT07732231Nantes University HospitalCost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage | 2027-01-01 |
| NCT06647849University Hospital, AngersInterest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients | 2027-06-11 |
| NCT05789940University Hospital, MontpellierHysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention | 2027-09-18 |
| NCT05557201Assistance Publique - Hôpitaux de ParisCohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors | 2027-10 |
Among the 27 studies in Abortion, Spontaneous with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Outpatient manual vacuum aspiration under local anesthesia and inhaled analgesia (MEOPA).
Procedure: Manual vacuum aspiration (MVA)
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 consultation under local anesthesia and inhaled analgesia, using a manual vacuum aspirator and appropriate cannula. Post-procedure pelvic ultrasound to confirm complete evacuation.
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.
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.
Time frame: 3 months
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
Time frame: 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.
Time frame: 1 month
To assess patient satisfaction
To assess patient satisfaction: A numerical scale (NS) (0-10) on Days 1 and 2.
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 et 3 months
Plan to share: Undecided — Individual participant data may be shared upon reasonable request, subject to sponsor approval and compliance with French/EU data protection regulations (GDPR).
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.
Of 43 non-industry interventional studies with no phase under Abortion, Spontaneous, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 3 months is below that.
Counting every sponsor, half of 45 studies reached it within 27 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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