NCT07732231

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
860

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

May 28, 2026

Last Update Submit

July 27, 2026

Conditions

MiscarriagePregnancy LossFirst Trimester Pregnancy

Keywords

Manual vacuum aspirationElectric aspirationCost-effectivenessHealth economicsGynecologyPregnancy lossmiscarriage

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    up to 5 years

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

    1 month

  • To assess patient satisfaction

    day 1 and 2

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

    days 0, 1,7 and 1 and 3 months

  • The risk factors for failure

    3 months

  • +10 more secondary outcomes

Study Arms (2)

Manual vacuum aspiration (MVA)

EXPERIMENTAL

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. 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.

Procedure: Electric aspiration (EA)

Interventions

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.

Manual vacuum aspiration (MVA)
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.

Electric aspiration in the operating room under general or regional anesthesia. Electric aspiration

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Thibault Thubert, Pr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thibault Thubert, Pr

CONTACT

+33253482443thibault.thubert@chu-nantes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2026

First Posted

July 28, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

October 1, 2029

Last Updated

July 28, 2026

Record last verified: 2026-07

Locations

FR(1)