Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy

NCT07088510 | Recruiting DMC

• 1 other identifier: STUDY20240983
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Miscarriage in First Trimester

Keywords

hysteroscopy; dilation and curettage; Manual Vacuum Aspiration

Outcome Measures

Primary Outcomes (1)

• Change in beta human chorionic gonadotropin (bHCG) levels as measured by blood test

  Baseline, 1 week post operation, 2 week post operation, 3 week post operation, 4 week post operation, 5 week post operation

Secondary Outcomes (7)

• Number of uterine adhesions detected by follow up hysteroscopy

  4 weeks post operation

• Number of post operative bleeding incidences as measured by nurse observation

  Up to 1 hour post operation

• Time in minutes to complete procedure

  Up to 30 minutes

• Number of retained products of conception as seen on follow up hysteroscopy

  1 month post operation

• Number of additional treatments needed as measured by follow up hysteroscopy

  1 month post operation

Study Arms (2)

Hysteroscopy

EXPERIMENTAL

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

Procedure: Hysteroscopic resection

Manual Vacuum Aspiration

ACTIVE COMPARATOR

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

Procedure: Manual Vacuum Aspiration

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.

Hysteroscopy

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.

Manual Vacuum Aspiration

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Findley, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

• Archana Ayyar, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kylie Phillips

CONTACT

216-285-5028; kylie.phillips@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)