Operative Hysteroscopic Using a Tissue Removal Device for Surgical Management of Early Pregnancy Loss Without Anesthesia - A Pilot Study
This small pilot study will assess whether early pregnancy loss (miscarriage) can be treated in an outpatient clinic using hysteroscopy without anesthesia, how well patients tolerate the procedure, and what complications occur. Hysteroscopy uses a small-diameter instrument with a camera to see inside the womb (uterus). A tissue removal device allows the doctor to remove pregnancy tissue while watching it directly.
The study will enroll 20 patients with pregnancy loss at up to 8 weeks of pregnancy who have chosen surgical treatment over medical treatment or expectant management. All participants will receive the study procedure; there is no comparison group. Researchers will record whether the pregnancy tissue is completely removed, pain during and shortly after the procedure, procedure duration, and complications. If the procedure cannot be completed or a participant asks to stop because of discomfort, an alternative procedure using suction aspiration (i.e., the traditional procedure for surgical abortion) will be offered the same day under sedation.
Participants will be invited to a follow-up visit 4-6 weeks later. This visit will include an ultrasound scan and diagnostic hysteroscopy to check for remaining pregnancy tissue or scar tissue inside the womb. The findings will provide an initial assessment of this approach and help guide future research.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Noam Smorgick, MD
- Phone Number: +972-6555185
- Email: noamsm@szmc.org.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Gestational age up to 8 weeks of gestation (calculated from the first day of the last menstrual period) and a gestational sac measuring < 20 mm in diameter on pelvic ultrasound.
- Age > 18 years
- Patients able to provide informed consent and to read/write Hebrew
Exclusion Criteria:
- Heavy vaginal bleeding or diagnosis of incomplete miscarriage (incomplete abortion)
- Signs of infection and/or suspected septic abortion
- Previous medical or surgical treatment in the current pregnancy
- History of intrauterine adhesions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Operative Hysteroscopy
Surgical evacuation by office operative hysteroscopy |
Use of operative hysteroscopy (Mini-elite Truclear) in the office etting for removal of early pregnancy loss for |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedural success
Time Frame: 1 day
|
Proportions of successful and unsuccessful procedures |
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedure time
Time Frame: 1 day
|
Measurement of duration of the procedures in minutes |
1 day
|
|
Intraoperative pain
Time Frame: During the procedure
|
Maximal pain measured by 10 cm VAS |
During the procedure
|
|
Postoperative pain
Time Frame: 5 minutes after the procedure
|
Maximal pain measured by 10 cm VAS |
5 minutes after the procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0421-26-SZMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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