First Trimester Pregnancy, Miscarriage, Pregnancy Loss
Conditions
Keywords
Manual vacuum aspiration, Electric aspiration, Cost-effectiveness, Health economics, Gynecology, Pregnancy loss, miscarriage
Brief 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.
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
PROCEDUREManual 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.
PROCEDUREElectric 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.
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| To compare the two management strategies in terms of success and intraoperative and postoperative complications | 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. |
| To assess patient satisfaction | day 1 and 2 | To assess patient satisfaction: A numerical scale (NS) (0-10) on Days 1 and 2. |
| To compare the two strategies (electric suction versus manual vacuum kit suction) | 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 |
| The risk factors for failure | 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). |
| Satisfaction with the patient's care by medical staff | 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 |
| Patient having been pregnant in days | 12 months | Patient having been pregnant at 12 months, pregnancy outcome and time to conception in days. |
Countries
France
Contacts
CONTACTThibault Thubert, Pr
PRINCIPAL_INVESTIGATORThibault Thubert, Pr
Nantes University Hospital
Outcome results
None listed