RecruitingNot ApplicableNCT07088510

Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy

A Randomized Control Trial Investigating Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy


Sponsor

University Hospitals Cleveland Medical Center

Enrollment

80 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria7

  • 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 Criteria6

  • 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

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Interventions

PROCEDUREHysteroscopic 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.

PROCEDUREManual 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.


Locations(1)

University Hospitals

Cleveland, Ohio, United States

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NCT07088510


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