- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06309927
Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss (Miscarriage)
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:
- Surgical uterine evacuation by the traditional ultrasound-guided suction curettage (control group)
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Noam Smorgick, MD
- Phone Number: +972-8-9779000
- Email: nsmorgik@shamir.gov.il
Study Locations
-
-
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Be'er Ya'aqov, Israel, 70200
- Shamir Medical Center
-
Contact:
- Noam Smorgick, MD
- Email: nsmorgik@shamir.gov.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Early pregnancy loss (miscarriage) up to 10 gestational weeks
- Able to give informed consent, and read/write in Hebrew
Exclusion Criteria:
- Incomplete abortion presenting as heavy vaginal bleeding and dilated cervix
- Signs of infection and/or suspicion of septic abortion
- Previous diagnosis of Mullerian anomalies - septate, bicornuate, unicornuate or didelphi uterus
- Previous medical or surgical treatment in the current pregnancy
- Previous diagnosis or past surgery for intrauterine adhesions
- History of 2 or more prvious miscarriages
- History of 2 or more cesarean sections
- History of abdominal, vaginal or hysteroscopic myomectomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Operative hysteroscopy
Surgical evacuation of the uterine cavity by operative hysteroscopy (tissue removal device, Truclear Mini-Elite)
|
Surgical evacuation of the uterine cavity using the Truclear Mini-Elite hysteroscopic tissue removal device
|
Active Comparator: Suction curettage
Surgical evacuation of the uterine cavity by ultrasound guided suction curettage
|
Surgical evacuation of the uterine cavity with electrical vacuum suction curette
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative complications
Time Frame: 1 week
|
Short term surgical complications including estimated blood loss > 500 ml, fluid deficit > 2500 ml, uterine perforation, re-admission, fever
|
1 week
|
Intrauterine adhesions
Time Frame: 6 weeks
|
Assessment of intrauterine adhesions by diagnostic office hysteroscopy
|
6 weeks
|
Subsequent fertility
Time Frame: 6 months
|
Rates of subsequent pregnancy
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conversion from operative hysteroscopy to suction curettage
Time Frame: 1 day
|
Inability to complete uterine evacuation by operative hysteroscopy
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Noam Smorgick, MD, Assaf-Harofeh Medical Center
Publications and helpful links
General Publications
- 1. Quenby S, Gallos ID, Dhillon-Smith RK, Podesek M, Stephenson MD, Fisher J, Brosens JJ, Brewin J, Ramhorst R, Lucas ES, McCoy RC, Anderson R, Daher S, Regan L, Al-Memar M, Bourne T, MacIntyre DA, Rai R, Christiansen OB, Sugiura-Ogasawara M, Odendaal J, Devall AJ, Bennett PR, Petrou S, Coomarasamy A. Miscarriage matters: the epidemiological, physical, psychological, and economic costs of early pregnancy loss. Lancet. 2021;397:1658-1667. 2. ACOG Practice Bulletin No. 200 Summary: Early Pregnancy Loss. Obstet Gynecol. 2018;132:1311-1313. 3. Shaker M, Smith A. First Trimester Miscarriage. Obstet Gynecol Clin North Am. 2022;49:623-635. 4. Upadhyay UD, Desai S, Zlidar V, Weitz TA, Grossman D, Anderson P, Taylor D. Incidence of emergency department visits and complications after abortion. Obstet Gynecol. 2015;125:175-183. 5. Paul ME, Mitchell CM, Rogers AJ, Fox MC, Lackie EG. Early surgical abortion: efficacy and safety. Am J Obstet Gynecol. 2002;187:407-11. 6. Hooker A, Fraenk D, Brölmann H, Huirne J. Prevalence of intrauterine adhesions after termination of pregnancy: a systematic review. Eur J Contracept Reprod Health Care. 2016;21:329-35. 7. Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008;89:759-79. 8. Catena U, D'Ippolito S, Campolo F, Dinoi G, Lanzone A, Scambia G. Hysteroembryoscopy and hysteroscopic uterine evacuation of early pregnancy loss: A feasible procedure in selected cases. Facts Views Vis Obgyn. 2022;14:193-197. 9. Young S, Miller CE. Hysteroscopic resection for management of early pregnancy loss: a case report and literature review. F S Rep. 2022;3:163-167. 10. Smorgick N, Barel O, Fuchs N, Ben-Ami I, Pansky M, Vaknin Z. Hysteroscopic management of retained products of conception: meta-analysis and literature review. Eur J Obstet Gynecol Reprod Biol. 2014;173:19-22. 11. Barel O, Krakov A, Pansky M, Vaknin Z, Halperin R, Smorgick N. Intrauterine adhesions after hysteroscopic treatment for retained products of conception: what are the risk factors? Fertil Steril. 2015;103:775-9. 12. Weinberg S, Pansky M, Burshtein I, Beller U, Goldstein H, Barel O. A Pilot Study of Guided Conservative Hysteroscopic Evacuation of Early Miscarriage. J Minim Invasive Gynecol. 2021;28:1860-1867. 13. Bar-On S, Berkovitz Shperling R, Cohen A, Akdam A, Michaan N, Levin I, Rattan G, Tzur Y. Primary Resectoscopic Treatment of First-Trimester Miscarriage. J Obstet Gynaecol Can. 2023:102327. 14. Huchon C, Drioueche H, Koskas M, Agostini A, Bauville E, Bourdel N, Fernandez H, Fritel X, Graesslin O, Legendre G, Lucot JP, Panel P, Raiffort C, Giraudet G, Bussières L, Fauconnier A. Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial. JAMA. 2023;329:1197-1205.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0025-24-ASF
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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