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The efficacy and safety of a CCT-102 regimen versus expectant management in the treatment of first trimester pregnancy loss
This study will compare the use of CCT-102 with expectant management to promote uterine evacuation in first trimester non-progressing Delayed Pregnancy Loss (DPL). Eligible participants will be randomly assigned to active treatment or expectant management and will undergo ultrasound, physical examination, sample collection and complete daily diaries.for six days. Participants will be monitored up to 208 days until a negative urine hCG test is achieved.
There are 3 visits and a screening visit which may be combined with visit 1. A physical examination, ultrasound and blood draw will take place at screening and visit 2. Urine pregnancy tests will be taken at screening, visit 1, visit 2 and at home on days 14, 21 and 28 or until a negative result occurs. Electronic diaries will be logged days 1 through 7
595
Hemodynamically stable
Closed cervical os
If fetus exists, gestation <10 weeks by clinical observation
Diagnosis of delayed pregnancy loss based on embryonic demise or anembryonic pregnancy
Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
Hemoglobin <10 g/dL, coagulation disorder, chronic adrenal failure
History of allergy or contraindications to use of mifepristone, misoprostol or prostaglandins
Current presence of an IUD