Recruiting

Hysteroscopic Resection vs. Manual Vacuum Aspiration

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT07088510

Conditions

Miscarriage in First Trimester

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Hysteroscopic resection

Manual Vacuum Aspiration

Study Details

Brief summary:

Early pregnancy loss happens when a pregnancy that is not developing properly is found on an ultrasound before 12 weeks and 6 days. This type of loss occurs in about 10% of pregnancies. There are three main ways to treat this: waiting for it to pass naturally, using medication, or having surgery. Surgery is the most effective, working 99% of the time, compared to waiting (80% effective in 8 weeks) and medication (71-84% effective). Currently, surgery involves dilation of the cervix and curettage (removal of pregnancy tissue) with suction provided either from a manual hand-held pump or a machine. For the purposes of this study, a manual vacuum aspirator (or hand-held pump) will be used with ultrasound guidance.

There is also another method called hysteroscopic resection, where the doctor uses a special camera to directly see and remove any pregnancy tissue from your uterus. Patients often want the quickest way to resolve the pregnancy loss, and physicians are unsure which surgical method is the best. It's also unclear if one type of surgery causes less scar tissue inside the uterus, affects the ability to test the tissue for genetic issues, or impacts how soon a patient can start fertility treatments again.

This study aims to find out if hysteroscopic resection provides faster resolution and creates less scar tissue compared to the manual vacuum aspiration.

Conditions

Miscarriage in First Trimester

Study ID

NCT07088510

Start date

Mar 31, 2025

Status verified date

Jul, 2025

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hysteroscopy

Participants will undergo hysteroscopic resection of early pregnancy loss under monitored anesthesia care.

active comparator: Manual Vacuum Aspiration

Participants will undergo manual vacuum aspiration of early pregnancy loss under monitored anesthesia care.

Interventions

Hysteroscopic resection

Participants will undergo a hysteroscopy where a camera is placed on the inside of the uterus. Then a resector will be used to remove the pregnancy loss under direct visualization.

Manual Vacuum Aspiration

Participants will undergo a manual vacuum aspiration with ultrasound guidance for treatment of early pregnancy loss. This is when pregnancy loss is suctioned by a machine from the uterus.

Primary outcome measure

  • Change in beta human chorionic gonadotropin (bHCG) levels as measured by blood test [ Time Frame: Baseline, 1 week post operation, 2 week post operation, 3 week post operation, 4 week post operation, 5 week post operation ]

Central Contacts and Locations

Central contacts

Locations

University Hospitals

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jul 30, 2025

Last verified

Jul, 2025

Keywords

  • hysteroscopy
  • dilation and curettage
  • Manual Vacuum Aspiration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2025-07-30.