Hysteroscopic removal versus manual vacuum aspiration for early miscarriage
A Randomized Control Trial Investigating Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy
This trial will test whether hysteroscopic resection or ultrasound-guided manual vacuum aspiration works better to remove pregnancy tissue in women with a first-trimester miscarriage under 9 weeks who choose surgical management.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07088510 on ClinicalTrials.gov |
What this trial studies
The trial compares hysteroscopic resection to ultrasound-guided manual vacuum aspiration for management of early (under 9 weeks) nonviable singleton pregnancies. Eligible adult women (18–55) who choose surgical management will undergo one of the two surgical approaches and be followed for resolution of retained products, return of beta-hCG to negative, need for repeat procedures, and development of intrauterine adhesions. Procedures are performed by gynecologic surgeons at University Hospitals with standard perioperative care and ultrasound guidance for the MVA arm. Outcomes and complications will be recorded to determine whether hysteroscopic resection offers faster or more complete removal of tissue than manual vacuum aspiration.
Who should consider this trial
Good fit: Adult women aged 18–55 with ultrasound-confirmed nonviable singleton pregnancy under 9 weeks who have chosen surgical management are ideal candidates.
Not a fit: Patients with pregnancies of unknown location, current viable pregnancies, prior medical treatment for the current loss, active infection, contraindications to surgery, or pre-existing coagulopathies are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, hysteroscopic resection could provide faster clearance of pregnancy tissue, fewer repeat procedures, and a lower risk of intrauterine adhesions compared with manual vacuum aspiration.
How similar studies have performed: Previous randomized and case-report data suggest hysteroscopic resection can improve completeness of removal and reduce need for additional procedures, but direct comparison to ultrasound-guided manual vacuum aspiration for early miscarriage remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult women age 18-55 * Ultrasound Diagnosis of Early Pregnancy Loss * \< 9 weeks gestational age as determined by ultrasound * Singleton non-viable pregnancy * Stated and willingness to comply with all study procedures and availability for the duration of the study * Provision of signed and dated informed consent form * Chose a surgical method of management for fetal loss Exclusion Criteria: * Pregnancy of Unknown Location * Current, viable pregnancy * Prior medical treatment for this early pregnancy loss * Contraindications to surgical management * Active infection (i.e. fever, chills, fundal tenderness) * Pre-existing coagulopathies
Where this trial is running
Cleveland, Ohio
- University Hospitals — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Joseph Findley, MD — University Hospitals
- Study coordinator: Kylie Phillips
- Email: kylie.phillips@uhhospitals.org
- Phone: 216-285-5028
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.