RECRUITING
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CCT-102 vs. Expectant Management in Delayed 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).
Conditions:
🦠 Early Pregnancy Loss, Delayed Pregnancy Loss
🗓️ Study Start (Actual) 21 July 2023
🗓️ Primary Completion (Estimated) 21 December 2024
✅ Study Completion (Estimated) 21 December 2024
👥 Enrollment (Estimated) 160
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 San Diego, California, United States
📍 Panama City, Florida, United States
📍 Idaho Falls, Idaho, United States
📍 Wichita, Kansas, United States
📍 Gulfport, Mississippi, United States
📍 Gulfport, Mississippi, United States
📍 Hastings, Nebraska, United States
📍 Hastings, Nebraska, United States
📍 Bronx, New York, United States
📍 New York, New York, United States
📍 New Bern, North Carolina, United States
📍 Winston-Salem, North Carolina, United States
📍 Cleveland, Ohio, United States
📍 Portland, Oregon, United States
📍 Hershey, Pennsylvania, United States
📍 Charleston, South Carolina, United States
📍 Galveston, Texas, United States
📍 Norfolk, Virginia, United States
📍 Virginia Beach, Virginia, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Age 18 to 50
    • 2. Ability to provide informed consent
    • 3. Hemodynamically stable
    • 4. Closed cervical os
    • 5. If fetus exists, clinical observation indicates gestation is no more than 10 weeks
    • 6. Diagnosis of delayed pregnancy loss, confirmed by ultrasound, based on:
    • 1. Embryonic demise: no embryonic cardiac activity when embryo measures 7 mm or greater; OR,
    • 2. Anembryonic pregnancy: mean gestational sac diameter of 25 mm or greater, with no detectable embryo.

    Exclusion Criteria:

    • 1. Unwillingness or inability to comply with the study protocol and visit schedule
    • 2. Diagnosis of an incomplete or inevitable abortion including more than slight bleeding at enrollment and/or open os within the prior week.
    • 3. Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
    • 4. Hemoglobin \<10 g/dL
    • 5. Coagulation disorder, inherited porphyrias, and/or current anticoagulants use
    • 6. Chronic adrenal failure
    • 7. Concurrent chronic corticosteroid therapy
    • 8. History of trophoblastic disease
    • 9. Current presence of an IUD
    • 10. History of allergy or contraindications to the use to mifepristone, misoprostol, or other prostaglandins
    • 11. Any condition that, in the opinion of the investigator, makes the patient unsuitable for study entry
    • 12. Any other current medical condition that jeopardizes the patient's ability to safely participate in the trial
Ages Eligible for Study: 18 Years to 50 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 November 2023
  • First Submitted that Met QC Criteria 2 November 2023
  • First Posted 7 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 July 2024
  • Last Update Posted 19 July 2024
  • Last Verified June 2024
I'm interested ...!!