Miscarriage in First TrimesterNCT07088510
Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy
A study testing Hysteroscopic resection and Manual Vacuum Aspiration in people with Miscarriage in First Trimester, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Miscarriage in First Trimester
- What is being tested?
- Hysteroscopic resection and Manual Vacuum Aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2025to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals
Cleveland, Ohio, 44106
Kylie Phillips, 216-285-5028, kylie.phillips@uhhospitals.org
About this study
Official title: A Randomized Control Trial Investigating Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy
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.
Read the 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
- Being tested
- Hysteroscopic resection, Manual Vacuum Aspiration
- Keywords
- hysteroscopy, dilation and curettage, Manual Vacuum Aspiration
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic resectionProcedure or surgery
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 AspirationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopy | Experimental | Participants will undergo hysteroscopic resection of early pregnancy loss under monitored anesthesia care. Receives: Procedure: Hysteroscopic resection |
| Manual Vacuum Aspiration | Active comparator | Participants will undergo manual vacuum aspiration of early pregnancy loss under monitored anesthesia care. Receives: Procedure: Manual Vacuum Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in beta human chorionic gonadotropin (bHCG) levels as measured by blood test
Measured: 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
Measured: 4 weeks post operation
Number of post operative bleeding incidences as measured by nurse observation
Measured: Up to 1 hour post operation
Time in minutes to complete procedure
Measured: Up to 30 minutes
Number of retained products of conception as seen on follow up hysteroscopy
Measured: 1 month post operation
Number of additional treatments needed as measured by follow up hysteroscopy
Measured: 1 month post operation
Time in months to next fertility treatment
Measured: Up to 12 months
Number of completed cytogenetic results as measured genetic testing
Measured: Up to 1 month post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start31 Mar 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Miscarriage in First TrimesterStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Findley MD, University Hospitals Cleveland Medical Center
- Investigators
- Joseph Findley, MD, Principal investigator, University HospitalsArchana Ayyar, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088510
- Sponsor's protocol ID
- STUDY20240983
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Investigating Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy
- ClinicalTrials.gov ID
- NCT07088510
- Acronym / sponsor ID
- STUDY20240983
- Conditions
- Miscarriage in First Trimester
- Keywords
- hysteroscopy, dilation and curettage, Manual Vacuum Aspiration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopy | Experimental | Procedure: Hysteroscopic resectionParticipants will undergo hysteroscopic resection of early pregnancy loss under monitored anesthesia care. |
| Manual Vacuum Aspiration | Active comparator | Procedure: Manual Vacuum AspirationParticipants will undergo manual vacuum aspiration of early pregnancy loss under monitored anesthesia care. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysteroscopic resectionParticipants 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. | Procedure or surgery | Hysteroscopy |
| Manual Vacuum AspirationParticipants 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. | Procedure or surgery | Manual Vacuum Aspiration |
Primary outcome
Change in beta human chorionic gonadotropin (bHCG) levels as measured by blood test
Time frame: Baseline, 1 week post operation, 2 week post operation, 3 week post operation, 4 week post operation, 5 week post operation
7 secondary outcomes
Number of uterine adhesions detected by follow up hysteroscopy
Time frame: 4 weeks post operation
Number of post operative bleeding incidences as measured by nurse observation
Time frame: Up to 1 hour post operation
Time in minutes to complete procedure
Time frame: Up to 30 minutes
Number of retained products of conception as seen on follow up hysteroscopy
Time frame: 1 month post operation
Number of additional treatments needed as measured by follow up hysteroscopy
Time frame: 1 month post operation
Time in months to next fertility treatment
Time frame: Up to 12 months
Number of completed cytogenetic results as measured genetic testing
Time frame: Up to 1 month post operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Miscarriage in First Trimester
Recruiting
GRACE - Genetic Insights Into Early pRegnancy Loss Using Cell-free fEtal DNA
Miscarriage in First Trimester, Prenatal Genetic Diagnosis
Recruiting
Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial
Retained Product of Conception After First Trimester Medical Abortion
RecruitingObservational study
Comprehensive Assessment of First Trimester Pregnancy Loss
Miscarriage in First Trimester
RecruitingPhase 4
Letrozole Plus Misoprostol Versus Misoprostol Alone for Treating Women With Missed Miscarriage
Miscarriage in First Trimester, Missed Miscarriage
RecruitingObservational study
Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)
Ultrasound-guided Manual Vacuum Aspiration, First Trimester Spontaneous Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Findley, MD principal investigator
University Hospitals
Archana Ayyar, MD principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopic resection and Manual Vacuum Aspiration in people with Miscarriage in First Trimester, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kylie Phillips (216-285-5028, kylie.phillips@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in beta human chorionic gonadotropin (bHCG) levels as measured by blood test (time frame: Baseline, 1 week post operation, 2 week post operation, 3 week post operation, 4 week post operation, 5 week post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.