Intracervical Vasopressin for Retained Products of Conception
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether injecting vasopressin into the cervix aids in removing retained products of conception (RPOC), which are leftover tissues in the uterus after a pregnancy ends. It compares the effects of vasopressin with a placebo (a harmless saline injection) during hysteroscopy, a surgical procedure where a doctor uses a camera to examine the uterus. Women undergoing surgery for RPOC after a miscarriage, abortion, or childbirth may be suitable candidates for this study. As a Phase 4 trial, this research involves an FDA-approved treatment to assess its benefits for a broader patient population.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for intracervical vasopressin?
Research shows that injecting vasopressin into the cervix is generally well-tolerated. Studies on similar procedures have found low rates of side effects. For instance, complications in procedures using a small camera to examine the uterus usually range from 1% to 5%, indicating that the treatment is relatively safe.
Vasopressin, approved by the FDA for various uses, has been safely used in other medical situations, which adds confidence about its safety in this trial. While all medicines can have side effects, evidence so far suggests that any risks associated with using vasopressin in this manner are likely low.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about using intracervical vasopressin for retained products of conception because it offers a targeted approach to managing this condition. Unlike standard options like surgical removal or medications that may cause systemic effects, vasopressin is administered directly to the cervix, potentially minimizing side effects. This method may enhance the body's ability to expel retained tissue more effectively, providing a safer alternative for patients seeking less invasive treatments.
What evidence suggests that intracervical vasopressin is effective for retained products of conception?
Research shows that injecting vasopressin into the cervix can enhance the effectiveness of procedures to remove leftover tissue after a miscarriage. In this trial, participants may receive either vasopressin or a placebo. Vasopressin tightens blood vessels and reduces blood flow, controlling bleeding during the procedure. Studies have found that using vasopressin in similar surgeries, such as fibroid removal, can almost halve surgery time. This suggests that vasopressin might expedite and improve the safety of removing leftover tissue. Therefore, promising evidence indicates that using vasopressin in these procedures could lead to better outcomes.12567
Who Is on the Research Team?
Paul Miller, MD
Principal Investigator
Prisma Health
Are You a Good Fit for This Trial?
This trial is for women aged 18-51 who are undergoing surgery to remove retained products of conception (RPOC) after a pregnancy has ended, whether due to miscarriage, abortion, or childbirth.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either intracervical vasopressin or placebo during the hysteroscopic procedure
Follow-up
Participants are monitored for surgical completion and secondary outcomes such as intraoperative bleeding and fluid deficit
What Are the Treatments Tested in This Trial?
Interventions
- Intracervical Vasopressin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Prisma Health-Upstate
Lead Sponsor