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A Phase 3, multi-center clinical trial of a CCT-102 regimen or expectant management to promote uterine evacuation in first trimester non-progressing Delayed Pregnancy Loss (DPL).
Full description
This is a Phase 3, open-label, multi-center study to assess the efficacy of a CCT-102 regimen 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 choose between the 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.
Enrollment
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Inclusion criteria
Age 18 to 50
Ability to provide informed consent
Hemodynamically stable
Closed cervical os
If fetus exists, clinical observation indicates gestation is no more than 10 weeks
Diagnosis of delayed pregnancy loss, confirmed by ultrasound, based on:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
160 participants in 2 patient groups
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Central trial contact
Sherri Thomas
Data sourced from clinicaltrials.gov
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