Comparing two methods for surgical termination of early pregnancy loss
Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss (Miscarriage)
This study is testing two different surgical methods for helping women who have early pregnancy loss to see which one is safer and works better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Assaf-Harofeh Medical Center Government |
| Locations | 1 site (Be'er Ya'aqov) |
| Trial ID | NCT06309927 on ClinicalTrials.gov |
What this trial studies
This study compares two surgical methods for managing early pregnancy loss in women up to 10 weeks gestation. Participants will be randomly assigned to either traditional suction curettage or operative hysteroscopy using a tissue removal device. The study aims to evaluate the operative time, blood loss, and complications associated with each method. All procedures will be performed under general anesthesia in an outpatient setting, with careful monitoring post-surgery.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with early pregnancy loss up to 10 gestational weeks who are able to provide informed consent.
Not a fit: Patients with incomplete abortions, signs of infection, or a history of certain uterine anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for women experiencing early pregnancy loss.
How similar studies have performed: Previous studies have indicated potential benefits of operative hysteroscopy over traditional methods, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Early pregnancy loss (miscarriage) up to 10 gestational weeks 2. Able to give informed consent, and read/write in Hebrew Exclusion Criteria: 1. Incomplete abortion presenting as heavy vaginal bleeding and dilated cervix 2. Signs of infection and/or suspicion of septic abortion 3. Previous diagnosis of Mullerian anomalies - septate, bicornuate, unicornuate or didelphi uterus 4. Previous medical or surgical treatment in the current pregnancy 5. Previous diagnosis or past surgery for intrauterine adhesions 6. History of 2 or more prvious miscarriages 7. History of 2 or more cesarean sections 8. History of abdominal, vaginal or hysteroscopic myomectomy
Where this trial is running
Be'er Ya'aqov
- Shamir Medical Center — Be'er Ya'aqov, Israel (Recruiting)
Study contacts
- Principal investigator: Noam Smorgick, MD — Assaf-Harofeh Medical Center
- Study coordinator: Noam Smorgick, MD
- Email: nsmorgik@shamir.gov.il
- Phone: +972-8-9779000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.