Actively Recruiting
A Randomized Control Trial Investigating Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy
Led by University Hospitals Cleveland Medical Center · Updated on 2025-07-30
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Early pregnancy loss, occurring in about 10% of pregnancies, is when a pregnancy that is not developing properly is found on ultrasound before 12 weeks and 6 days. This condition can be managed by waiting for it to pass naturally, using medication, or surgery. This research aims to compare two surgical methods — hysteroscopic resection and manual vacuum aspiration — to find out which provides faster resolution, less scar tissue, and better genetic testing results in women with early pregnancy loss. Participants will be randomly assigned to receive either hysteroscopic resection, where a camera and a resector remove pregnancy tissue under direct visualization, or manual vacuum aspiration, which uses a hand-held suction device with ultrasound guidance to remove tissue. Both procedures are done under monitored anesthesia care. The study will follow the participants over time to compare outcomes like tissue removal completeness, scar tissue formation, and genetic testing success. Throughout the study, participants will have blood tests to measure beta human chorionic gonadotropin (bHCG) levels weekly up to 5 weeks post-operation. Follow-up hysteroscopies will check for uterine adhesions and retained tissue at 4 weeks and 1 month. Researchers will also monitor bleeding right after surgery and track time to next fertility treatment for up to 12 months. Genetic testing results from the removed tissue will be evaluated within one month. The study runs until April 2028, including all these assessments and monitoring.
CONDITIONS
Brief Title
Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult women age 18 to 55
- Ultrasound diagnosis of early pregnancy loss
- Gestational age less than 9 weeks as determined by ultrasound
- Singleton non-viable pregnancy
- Willingness to comply with all study procedures and availability for the study duration
- Signed and dated informed consent form
- Chose surgical management for fetal loss
You will not qualify if you...
- Pregnancy of unknown location
- Current viable pregnancy
- Prior medical treatment for this early pregnancy loss
- Contraindications to surgical management
- Active infection such as fever, chills, or fundal tenderness
- Pre-existing blood clotting disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 minutes
Participants will undergo either hysteroscopic resection or manual vacuum aspiration to remove early pregnancy loss under monitored anesthesia care.
1 procedure visit (in-person)
Duration - Up to 5 weeks
Participants will have follow-up visits to monitor recovery, assess uterine healing, measure beta human chorionic gonadotropin (bHCG) levels, and evaluate genetic test results.
Weekly visits for up to 5 weeks, including a follow-up hysteroscopy at 4 weeks post operation
Trial Site Locations
Total: 1 location
1
University Hospitals
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
K
Kylie Phillips
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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