Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss … (NCT06309927) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss (Miscarriage)
Israel100 participantsStarted 2024-04-01
Plain-language 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. Surgical uterine evacuation by the traditional ultrasound-guided suction curettage (control group)
2. 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.