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

NCT06309927 | Active Not Recruiting

• 1 other identifier: 0025-24-ASF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Early Pregnancy Loss; Intrauterine Adhesion

Keywords

hysteroscopy; curettage; early pregnancy loss; tissue removal device

Outcome Measures

Primary Outcomes (3)

• Operative complications

  Short term surgical complications including estimated blood loss \> 500 ml, fluid deficit \> 2500 ml, uterine perforation, re-admission, fever

  1 week

• Intrauterine adhesions

  Assessment of intrauterine adhesions by diagnostic office hysteroscopy

  6 weeks

• Subsequent fertility

  Rates of subsequent pregnancy

  6 months

Secondary Outcomes (1)

• Conversion from operative hysteroscopy to suction curettage

  1 day

Study Arms (2)

Operative hysteroscopy

EXPERIMENTAL

Surgical evacuation of the uterine cavity by operative hysteroscopy (tissue removal device, Truclear Mini-Elite)

Procedure: Operative hysteroscopy (by tissue removal device)

Suction curettage

ACTIVE COMPARATOR

Surgical evacuation of the uterine cavity by ultrasound guided suction curettage

Procedure: Suction curettage

Interventions

Operative hysteroscopy (by tissue removal device) PROCEDURE

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

Operative hysteroscopy

Suction curettage PROCEDURE

Surgical evacuation of the uterine cavity with electrical vacuum suction curette

Suction curettage

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Early pregnancy loss (miscarriage) up to 10 gestational weeks
• Able to give informed consent, and read/write in Hebrew

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir Medical Center

Be’er Ya‘aqov, 70200, Israel

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Abortion, Spontaneous; Gynatresia

Interventions

Vacuum Curettage

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dilatation and Curettage; Curettage; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Noam Smorgick, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Minimally Invasive Gynecologic Surgery

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: April 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: February 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)