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.
Adult women age 18-55
Ultrasound Diagnosis of Early Pregnancy Loss
< 9 weeks gestational age as determined by ultrasound
Singleton non-viable pregnancy
Pregnancy of Unknown Location
Current, viable pregnancy
Prior medical treatment for this early pregnancy loss
Contraindications to surgical management
Parallel
Hysteroscopic resection
Procedure/SurgeryParticipants 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/SurgeryParticipants 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.
Change in beta human chorionic gonadotropin (bHCG) levels as measured by blood test
Number of uterine adhesions detected by follow up hysteroscopy
Number of post operative bleeding incidences as measured by nurse observation
Time in minutes to complete procedure
Number of retained products of conception as seen on follow up hysteroscopy
Click on the lead sponsor to view all of their trials.
