Operative Hysteroscopic Using a Tissue Removal Device for Surgical Management of Early Pregnancy Loss Without Anesthesia - A Pilot Study

This prospective, single-arm, non-blinded pilot study will evaluate the feasibility, patient tolerability, and safety of office-based operative hysteroscopy using a tissue removal device for surgical management of early pregnancy loss without anesthesia. The study will enroll 20 participants at Shaare Zedek Medical Center. There will be no comparison group.

Hysteroscopy allows direct visualization of the uterine cavity and targeted removal of pregnancy tissue. This study will assess whether this approach can be completed in an outpatient setting without anesthesia and will provide preliminary information on procedural success, pain, and complications.

Patients presenting to the gynecological emergency department with early pregnancy loss who have chosen surgical management will be offered participation. Eligible participants must be older than 18 years, have a gestational age of up to 8 weeks calculated from the first day of the last menstrual period, and have a gestational sac measuring less than 20 mm in diameter on pelvic ultrasound. Participants must be able to provide informed consent and read and write Hebrew. Patients with heavy vaginal bleeding, incomplete miscarriage, signs of infection or suspected septic miscarriage, previous medical or surgical treatment during the current pregnancy, or a history of intrauterine adhesions will be excluded.

Following clinical and ultrasound assessment and written informed consent, the study procedure will be scheduled within one week of the initial emergency department assessment. Experienced hysteroscopic surgeons will perform the procedure in the outpatient hysteroscopy suite without anesthesia. Participants will also provide separate informed consent for operative hysteroscopy. At the surgeon's discretion, selected participants may receive misoprostol for cervical preparation, as specified in the protocol.

Pregnancy tissue will be removed under direct hysteroscopic visualization using the mini-Elite TruClear tissue removal system with the mini-soft-tissue shaver. Normal saline will be used to distend the uterine cavity. Removed tissue will be submitted for pathological examination. Procedure duration, estimated blood loss, fluid deficit, and intraoperative complications will be recorded. Maximum pain during the procedure will be assessed using a 10-cm visual analogue scale.

Procedural success will be defined as complete hysteroscopic removal of pregnancy tissue while the participant remains comfortable. Incomplete removal because of limited visibility or termination at the participant's request because of discomfort will be classified as an unsuccessful procedure. These participants will be offered standard vacuum aspiration under sedation in the operating room or manual vacuum aspiration without anesthesia in the clinic. The chosen alternative procedure will be completed the same day.

After the procedure, participants will be observed in the clinic recovery room for 30 minutes. Vital signs and postoperative bleeding will be assessed, and pain will be measured 5 minutes after the procedure using the same visual analogue scale. Oral analgesia will be offered and administered on request, and its use will be documented. Participants who remain clinically well after observation will be discharged home.

All participants will be invited to a follow-up visit 4-6 weeks after the procedure. Follow-up will include assessment of postoperative adverse events, including excessive pain, excessive bleeding, fever, urgent medical consultations, and emergency department visits. Office hysteroscopy and transvaginal pelvic ultrasound will be performed to assess for intrauterine adhesions and retained pregnancy tissue. Abnormal findings will be documented, and further management will be recommended according to standard clinical criteria.

Study outcomes will include the proportions of successful and unsuccessful procedures, procedure duration, intraoperative and postoperative complications, the proportion of participants with a pain score greater than 6 during or after the procedure, and the rates of intrauterine adhesions and retained pregnancy tissue at follow-up. Intraoperative complications assessed will include uterine perforation, estimated blood loss greater than 250 mL, and fluid deficit greater than 2,500 mL. Postoperative complications assessed will include fever, vaginal bleeding requiring a repeat procedure, and readmission within one month.

No formal sample size calculation is planned because this is an exploratory pilot study. The sample of 20 participants is intended to provide an initial assessment of feasibility, tolerability, and observed complications rather than to test a definitive efficacy hypothesis. Findings will be interpreted in light of the small sample size, particularly its limited ability to assess uncommon adverse events.

Surgical evacuation by office operative hysteroscopy

Device: Operative hysteroscopy using the tissue removal device

Use of operative hysteroscopy (Mini-elite Truclear) in the office etting for removal of early pregnancy loss for

Time frame: 1 day

Proportions of successful and unsuccessful procedures

Time frame: 1 day

Measurement of duration of the procedures in minutes

Time frame: During the procedure

Maximal pain measured by 10 cm VAS

Time frame: 5 minutes after the procedure

Maximal pain measured by 10 cm VAS

Operative Hysteroscopic Using a Tissue Removal Device for Surgical Management of Early Pregnancy Loss Without Anesthesia - A Pilot Study