What side effects are associated with this type of intervention?

The most common treatments for miscarriage that promote uterine evacuation in the first trimester include mifepristone and misoprostol. Known side effects of mifepristone include nausea, vomiting, diarrhea, and abdominal pain. Misoprostol can cause cramping, bleeding, nausea, vomiting, diarrhea, and fever. These side effects are generally temporary and manageable, but it is important for patients to discuss any concerns with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved the use of mifepristone in combination with misoprostol for the medical management of miscarriage, specifically for promoting uterine evacuation in cases of missed miscarriage. This combination has been shown to be more effective than misoprostol alone in resolving missed miscarriages. Mifepristone is a progesterone receptor antagonist that helps to prime the uterus, making it more responsive to the effects of misoprostol, which induces uterine contractions to expel the pregnancy tissue.

What other types of research exist?

Promising alternatives to CCT-102 for promoting uterine evacuation in first trimester non-progressing Delayed Pregnancy Loss include mifepristone combined with misoprostol, which has been shown to be effective in inducing uterine evacuation. Additionally, expectant management remains a viable option for some patients, allowing the body to naturally expel the pregnancy tissue. Both methods have been supported by clinical evidence and are widely used in practice.

← Back to Search

Other

CCT-102 for Miscarriage (MERMAID Trial)

Phase 3

Recruiting

Research Sponsored by Conceptra Biosciences, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 50

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a treatment called CCT-102 to help women who have early pregnancies that stopped developing. The treatment aims to help clear the non-developing pregnancy tissue from their uterus. The study compares this treatment to simply waiting and monitoring the condition.

Who is the study for?

This trial is for women aged 18 to 50 who have experienced a non-progressing miscarriage in the first trimester. Participants must be stable, able to consent, and have specific clinical signs of early pregnancy loss with no more than 10 weeks gestation.

What is being tested?

The study compares CCT-102 A and CCT-102 B treatments against waiting for natural resolution in cases of delayed pregnancy loss. It aims to see if these treatments can help clear the uterus more effectively than expectant management.

What are the potential side effects?

Potential side effects are not detailed here but may include symptoms related to medication-induced uterine evacuation such as cramping, bleeding, nausea, or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Resolution of pregnancy loss

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: CCT-102 RegimenActive Control1 Intervention

CCT-102 A/B regimen

Group II: Expectant managementActive Control1 Intervention

Non-treatment, 'waitful watching'

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for miscarriage, particularly for promoting uterine evacuation in first trimester non-progressing Delayed Pregnancy Loss (DPL), include medical and surgical options. Medical management typically involves medications like misoprostol and mifepristone. Misoprostol induces uterine contractions to expel the pregnancy tissue, while mifepristone blocks progesterone, a hormone necessary for pregnancy continuation, making the uterus more responsive to misoprostol. Surgical management, such as dilation and curettage (D&C), involves physically removing the pregnancy tissue from the uterus. These treatments are crucial for miscarriage patients to prevent complications like infection, heavy bleeding, and to ensure the complete evacuation of the uterus, promoting physical and emotional recovery.