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NCT07732231

Overview

NCT ID: NCT07732231
Lead Sponsor: Nantes University HospitalOTHER
Official Title: Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage (ASPIR Study)
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.
Conditions: Miscarriage
Pregnancy Loss
First Trimester Pregnancy
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: Jan 1, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 860Estimated
Primary Purpose: Health Services Research
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Thibault Thubert, PrContact
thibault.thubert@chu-nantes.fr+33253482443

Similar Studies

Participant Group/Arms

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 aspirationActive 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)