Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy

Conditions

• Miscarriage in First Trimester

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Hysteroscopic resection — PROCEDURE
  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 — PROCEDURE
  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.

Study Details

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.

Key Dates

Start date

Mar 31, 2025

Status verified

Jul 2025

Primary completion

Apr 30, 2027

Completion

Apr 30, 2028

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Kylie Phillips
  216-285-5028
  [email protected]

Locations (1)

Find similar trials in Cleveland, OH

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• Letrozole and Misoprostol for Early Pregnancy Loss Management
  PHASE2 · Recruiting · University of Pennsylvania · Philadelphia, Pennsylvania