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Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss (Miscarriage)

NCT06309927 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-27

No results posted yet for this study

Summary

Non-blinded prospective randomized study. 100 women diagnosed with early pregnancy loss up to 10 gestational weeks who opted for surgical management (after being offered the options of conservative management and medical treatment) will be recruited.

Qualifying patients will sign an informed consent form and will be randomly assigned to the two arms of the study:

1. Surgical uterine evacuation by the traditional ultrasound-guided suction curettage (control group)
2. Surgical uterine evacuation by operative hysteroscopy using a tissue removal device (study group).

The surgical procedure will be determined randomly by computer generated allocation.

All surgical procedures will be performed under general anesthesia in an outpatient surgical suite. The operative time, operative blood loss and intraoperative complications will be recorded by the research team.

Following the surgical procedure, the patients will be monitored and discharged home as per our department's day-surgery protocol. Immediate post-operative complications will be recorded until discharge.

One week after the procedure, a telephone interview will be conducted to assess any procedure-related complications.

A diagnostic hysteroscopy without anesthesia will be scheduled 6 weeks postoperatively to assess for retained products of conception and for intrauterine adhesions. The diagnostic hysteroscopy will be performed by a practitioner who will be blinded to the type of surgery performed.

6 months after the procedure, a telephone questionnaire will be conducted to assess for subsequent pregnancies.

Conditions

  • Early Pregnancy Loss
  • Intrauterine Adhesion

Interventions

PROCEDURE

Operative hysteroscopy (by tissue removal device)

Surgical evacuation of the uterine cavity using the Truclear Mini-Elite hysteroscopic tissue removal device

PROCEDURE

Suction curettage

Surgical evacuation of the uterine cavity with electrical vacuum suction curette

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Principal Investigators

  • Noam Smorgick, MD · Assaf-Harofeh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-03-30
Completion
2026-02-28

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06309927 on ClinicalTrials.gov