RECRUITING

Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-31
Study Completion:2028-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07088510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult women age 18-55
  2. * Ultrasound Diagnosis of Early Pregnancy Loss
  3. * \< 9 weeks gestational age as determined by ultrasound
  4. * Singleton non-viable pregnancy
  5. * Stated and willingness to comply with all study procedures and availability for the duration of the study
  6. * Provision of signed and dated informed consent form
  7. * Chose a surgical method of management for fetal loss
  1. * Pregnancy of Unknown Location
  2. * Current, viable pregnancy
  3. * Prior medical treatment for this early pregnancy loss
  4. * Contraindications to surgical management
  5. * Active infection (i.e. fever, chills, fundal tenderness)
  6. * Pre-existing coagulopathies

Contacts and Locations

Study Contact

Kylie Phillips
CONTACT
216-285-5028
kylie.phillips@uhhospitals.org

Principal Investigator

Joseph Findley, MD
PRINCIPAL_INVESTIGATOR
University Hospitals
Archana Ayyar, MD
PRINCIPAL_INVESTIGATOR
University Hospitals

Study Locations (Sites)

University Hospitals
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: University Hospitals Cleveland Medical Center

  • Joseph Findley, MD, PRINCIPAL_INVESTIGATOR, University Hospitals
  • Archana Ayyar, MD, PRINCIPAL_INVESTIGATOR, University Hospitals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-31
Study Completion Date2028-04-30

Study Record Updates

Study Start Date2025-03-31
Study Completion Date2028-04-30

Terms related to this study

Keywords Provided by Researchers

  • hysteroscopy
  • dilation and curettage
  • Manual Vacuum Aspiration

Additional Relevant MeSH Terms

  • Miscarriage in First Trimester