Hysteroscopic Resection for Early Pregnancy Loss

Overseen By Kylie Phillips

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Viable pregnancy, Active infection, Coagulopathies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgical methods to treat early pregnancy loss: hysteroscopic resection, where a doctor uses a camera to see and remove tissue, and manual vacuum aspiration, which uses a hand-held pump. The trial aims to determine which method clears the pregnancy faster and causes less scar tissue. Women with a confirmed early pregnancy loss on an ultrasound who have chosen surgery may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance treatment options for early pregnancy loss.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hysteroscopic resection safely manages early pregnancy loss. Studies have found it practical and safe, yielding good results. For example, one study found that patients undergoing this procedure were more likely to have full-term pregnancies and less likely to experience subsequent miscarriages.

Manual vacuum aspiration, another widely used method, is considered effective and generally well-tolerated by patients. Its long history of safe use supports its continued application for treating early pregnancy loss.

Both treatments are surgical options with some risks, but current research supports their safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using hysteroscopic resection for early pregnancy loss because it offers a precise, minimally invasive approach to removing tissue. Unlike traditional methods like manual vacuum aspiration or dilation and curettage, hysteroscopic resection allows for direct visualization of the uterine cavity, which can lead to more complete removal of pregnancy tissue and potentially fewer complications. This technique could improve recovery times and reduce the risk of infection, making it a promising option for managing early pregnancy loss.

What evidence suggests that this trial's treatments could be effective for early pregnancy loss?

Research has shown that hysteroscopic resection, one of the treatments studied in this trial, can effectively manage early pregnancy loss. A case report highlighted its successful use, suggesting it could be a dependable option. Studies have also found that this method results in less scar tissue inside the uterus compared to other surgical methods. Reducing scar tissue is important because it can impact future fertility. Considering these points, hysteroscopic resection appears promising for those experiencing early pregnancy loss. Another treatment option in this trial is manual vacuum aspiration, which researchers will compare to hysteroscopic resection to evaluate effectiveness and outcomes. ^{2 3 6 7 8}

Who Is on the Research Team?

Joseph Findley, MD

Principal Investigator

University Hospitals

Archana Ayyar, MD

Principal Investigator

University Hospitals

Are You a Good Fit for This Trial?

This trial is for adult women aged 18-55 who have been diagnosed with an early pregnancy loss before 9 weeks of gestation, as confirmed by ultrasound. It's specifically for those choosing surgery to manage the loss and willing to follow study procedures throughout the study duration.

Inclusion Criteria

* Adult women age 18-55

* Ultrasound Diagnosis of Early Pregnancy Loss

* \< 9 weeks gestational age as determined by ultrasound

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either hysteroscopic resection or manual vacuum aspiration for early pregnancy loss under monitored anesthesia care

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, resolution of pregnancy loss, and potential scar tissue formation

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hysteroscopic resection
• Manual Vacuum Aspiration

Trial Overview The trial compares two surgical methods: hysteroscopic resection (using a camera to see and remove tissue) versus manual vacuum aspiration (using a hand-held pump with ultrasound guidance) for treating early pregnancy loss.

How Is the Trial Designed?

Group I: Hysteroscopy Experimental Treatment 1 Intervention

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

Group II: Manual Vacuum Aspiration Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Citations

1. fertstertreports.org fertstertreports.org/article/S2666-3341(22)00028-9/fulltext

Hysteroscopic resection for management of early ... This case report demonstrates the successful application of hysteroscopic resection in a case of early pregnancy loss.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40882453/

Impact of hysteroscopic septum resection on pregnancy ... After surgery, the proportion of patients with early miscarriage decreased from 35.6 % (36/101) to 14.8 % (15/101) (p < 0.001) and recurrent miscarriage from ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211525009510

Impact of hysteroscopic septum resection on pregnancy ... After surgery, the proportion of patients with early miscarriage decreased from 35.6 % (36/101) to 14.8 % (15/101) (p < 0.001) and recurrent miscarriage from ...

4. ejog.org ejog.org/article/S0301-2115(24)00548-7/fulltext

The HYsteroscopic Miscarriage MaNagement (HYMMN) ... 115 patients (91%) were able to provide pregnancy data, however, the study was not powered to show a clinically significant difference.

5. fertstert.org fertstert.org/article/S0015-0282(24)01915-0/fulltext

HYSTEROSCOPY FOR EARLY PREGNANCY LOSS CONCLUSIONS. Hysteroscopic management of early pregnancy loss is a viable option for treatment of EPL. There are decreased intrauterine adhesions after this ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9250123/

Hysteroscopic resection for management of early ... This case report demonstrates the successful application of hysteroscopic resection in a case of early pregnancy loss.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07143578

Comparison of Surgical Management of Early Pregnancy ... Previous studies indeed found that hysteroscopy was feasible and safe for the surgical management of early pregnancy loss. The investigators recently ...

8. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.889696/full

Pregnancy and Adverse Obstetric Outcomes After ... Hysteroscopic resection was related to a higher rate of term delivery (OR = 2.26, 95% CI, 1.26–4.05), and a lower rate of spontaneous abortion ( ...