RECRUITING

Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy

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.

Study Overview

Study Details

Study overview

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.

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

Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy

Condition
Miscarriage in First Trimester
Intervention / Treatment

-

Contacts and Locations

Cleveland

University Hospitals, Cleveland, Ohio, United States, 44106

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University Hospitals Cleveland Medical Center,

Joseph Findley, MD, PRINCIPAL_INVESTIGATOR, University Hospitals

Archana Ayyar, MD, PRINCIPAL_INVESTIGATOR, University Hospitals

Study Record Dates

2028-04-30