Early Pregnancy Loss, Delayed Pregnancy Loss Clinical Trial
Official title:
The Efficacy and Safety of a CCT-102 Regimen Versus Expectant Management in the Treatment of First Trimester Pregnancy Loss
A Phase 3, multi-center clinical trial of a CCT-102 regimen compared to expectant management to promote uterine evacuation in first trimester non-progressing Delayed Pregnancy Loss (DPL).
This is a Phase 3, open-label, multi-center study to assess the efficacy of a CCT-102 regimen compared to expectant management for uterine evacuation in first trimester delayed pregnancy loss (DPL). Eligible study participants will have ultrasound documented DPL with estimated gestational age 10 weeks or less. DPL is defined as arrest of embryonic or fetal development, in first trimester, where the cervix is closed and there is no or only slight bleeding. This includes: 1) anembryonic pregnancy, and 2) embryonic demise. Expectant management, which is an accepted treatment protocol recognized in 2018 ACOG Practice Bulletin on Early Pregnancy Loss (ACOG, 2018), consists of patient monitoring with no additional treatment. Eligible participants will be randomized 1:1 to investigational product or expectant management on Day 1. They will be evaluated for the primary endpoint (resolution of DPL) on Study Day 7. All participants will be followed to Day 28. ;