A Randomized Control Trial Investigating Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy
University Hospitals Cleveland Medical Center
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.
Description
Early pregnancy loss is when a nonviable intrauterine pregnancy is diagnosed on ultrasound prior to 12 weeks and 6 days of gestation and occurs in 10% of pregnancies. There are typically three treatment modalities: expectant management, medical management, or surgical management. Surgical management is 99% effective in comparison to expectant management (80% resolution within 8 weeks) and medical management (71-84%). Current standard surgical management includes manual vacuum aspiration or suction dilation and curettage with or without ultrasound guidance. Hysteroscopic resection of retained p…
Eligibility
- Age range
- 18–55 years
- Sex
- Female
- Healthy volunteers
- No
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 (…
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.
Location
- University HospitalsCleveland, Ohio