Clinical trial NCT05413525: Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)
Official title: Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ultrasound-guided Manual Vacuum Aspiration
First Trimester Spontaneous Abortion
Keywords: USG-MVA
Ultrasound-guided manual vacuum aspiration
Miscarriage
Cytological analysis
Manual vacuum aspiration
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with first trimester miscarriage

Brief summary: This is a retrospective study to review the current experience of USG-MVA in Hong Kong and also evaluate the effectiveness of USG-MVA in cytological analysis in the management of first trimester miscarriage.

Detailed description: Miscarriage can be managed expectantly, medically or surgically. In cases where cytogenetic analysis is wanted, surgical evacuation is the ideal option as the POC is difficult to be obtained after medical evacuation. However, traditional surgical evacuation requires the procedure to be performed under general anesthesia using an electric vacuum aspiration (EVA). Moreover, the chorionic villi obtained via POC is often less intact and dispersed, making the identification and analysis difficult. Manual vacuum aspiration (MVA) was first introduced in 1973. The procedure is performed using a hand-held 60ml syringe to create the suction force and the intrauterine contents are aspirated using either a flexible or rigid cannula attached on it. The procedure can be performed in an outpatient setting with simple oral analgesics or conscious sedation given beforehand.

The investigators have previously evaluated the acceptability and feasibility of the addition of ultrasound guidance during the procedure. The investigators found that ultrasound-guided manual vacuum aspiration (USG-MVA) is an effective alternative treatment modality to medical and traditional surgical evacuation under general anesthesia for the management of first trimester delayed or incomplete miscarriage. The procedure has been introduced in our locality since 2015. Since then, the investigators have performed more than 200 cases of USG-MVA locally. However, the subsequent local experience of USG-MVA and culture failure rate in the POC during cytological analysis obtained via this method remains limited in the literature.

Eligibility criteria: Inclusion Criteria:

* Women 18 years old or above
* Women with miscarriage who are suitable candidates for USG-MVA
* first trimester delayed miscarriage ≤ 12 weeks of gestation
* incomplete miscarriage with POG ≤ 5cm
* hemodynamically stable
* tolerates well with speculum examination

Exclusion Criteria:

* Women who are not feasible for the USG-MVA
* cervical stenosis
* fibroid uterus ≥12 weeks in size
* known uterine malformation
* bleeding disorder
* suspicion of active infection
* inability to tolerate pelvic examination
* History of allergy to misprostol or same group of medications

Primary outcomes:
measure: complete evacuation rate of the products of conception
timeFrame: Three weeks from surgery to follow-up
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Three weeks from surgery to follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
state: Shatin
city: Hong Kong
country: Hong Kong
facility: Union Hospital
Study officials:
References: