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NCT Number: NCT07732231

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

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.

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Key information

Conditions

Miscarriage Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications First Trimester Pregnancy Pregnancy Complications Pregnancy Loss Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual vacuum aspiration (MVA)

Procedure

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

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 outcomes

  1. 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.

Secondary outcomes

  1. 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

    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

  2. To compare the two management strategies in terms of success and intraoperative and postoperative complications

    Time frame: 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.

  3. To assess patient satisfaction

    Time frame: day 1 and 2

    To assess patient satisfaction:

    A numerical scale (NS) (0-10) on Days 1 and 2.

  4. To compare the two strategies (electric suction versus manual vacuum kit suction)

    Time frame: 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

  5. The risk factors for failure

    Time frame: 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).

  6. Satisfaction with the patient's care by medical staff

    Time frame: 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

  7. Patient having been pregnant in days

    Time frame: 12 months

    Patient having been pregnant at 12 months, pregnancy outcome and time to conception in days.

  8. To assess patient satisfaction

    Time frame: day 1 and 2 and 1 month et 3 month

    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

  9. To assess patient satisfaction

    Time frame: 1 and 3 months

    HADS (Hospital Anxiety and Depression Scale) and PCL-5 questionnaires at 1 and 3 months

  10. 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), 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

  11. 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), measurement of:

    ●Analgesic consumption (type, quantity, and duration) from Day 0 to 7

  12. 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), measurement of:

    ●Number of pads used per day (Higham score) from Days 1 to 7

  13. 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), measurement of:

    • Duration of the procedure in minutes
    • Waiting time for therapeutic treatment in minutes
    • Time spent in hospital in minutes

  14. 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)

    ● 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

  15. To compare the two strategies (electric suction versus manual vacuum kit suction)

    Time frame: 1 et 3 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Thibault Thubert, Pr

CONTACT

[email protected]

+33253482443

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: ASPIR

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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