Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy

NCT ID: NCT07088510

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2028-04-30

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.

Detailed 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 products of conception (RPOC) has been studied. A recent randomized control trial comparing this to vacuum curettage showed hysteroscopic resection of RPOC had an increase in completeness of removal of the RPOC and decreased need for additional treatment with either a second hysteroscopy or vacuum curettage. Although detailed in 1 case report and performed nationally, hysteroscopic resection in comparison to manual vacuum aspiration of early pregnancy loss has not been investigated. Potential benefits of hysteroscopic resection in comparison to manual vacuum aspiration include faster return to negative bHCG, decreased risk of intrauterine adhesion formation post-operatively, and decreased risk of retained products of conception. Furthermore, 50% of early pregnancy losses are due to fetal chromosomal abnormalities. Thus, diagnosis of a chromosomal abnormality can both provide information for the patient and allow for guidance of pregnancy treatment in the future. A retrospective chart review determined that obtaining fetal genetics is less likely to be contaminated with maternal tissue and is more likely to detect fetal chromosomes when the products of conception were biopsied hysteroscopically prior to suction dilation and curettage rather than when the pregnancy is terminated solely with suction dilation and curettage. Thus, hysteroscopic resection of early pregnancy loss may provide cytogenetic information that may not be obtained with a manual vacuum aspiration (similar technique as suction dilation and curettage, using manual suction instead of electric suction). This study aims to find out if hysteroscopic resection provides faster resolution of the pregnancy loss, creates less scar tissue, and improves genetic testing in comparison to manual vacuum aspiration.

Conditions

Miscarriage in First Trimester

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hysteroscopy

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

Group Type: EXPERIMENTAL

Hysteroscopic resection

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Manual Vacuum Aspiration

Intervention Type: 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.

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joseph Findley MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Findley, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals

Archana Ayyar, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals

Locations

University Hospitals

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kylie Phillips

Role: CONTACT

kylie.phillips@uhhospitals.org

216-285-5028

Facility Contacts

Kylie Phillips

Role: primary

kylie.phillips@uhhospitals.org

216-285-5028

Other Identifiers

STUDY20240983

Identifier Type: -

Identifier Source: org_study_id