CompletedPhase 3

CCT-102 or Expectant Management in Delayed Pregnancy Loss

United States183 participantsStarted 2023-07-21

Plain-language summary

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).

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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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:
✓. Embryonic demise: no embryonic cardiac activity when embryo measures 7 mm or greater; OR,
✓. Anembryonic pregnancy: mean gestational sac diameter of 25 mm or greater, with no detectable embryo.

Exclusion criteria

✕. Unwillingness or inability to comply with the study protocol and visit schedule
✕. Diagnosis of an incomplete or inevitable abortion including more than slight bleeding at enrollment and/or open os within the prior week.
✕. Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
✕. Hemoglobin \<10 g/dL
✕. Coagulation disorder, inherited porphyrias, and/or current anticoagulants use
✕. Chronic adrenal failure
✕. Concurrent chronic corticosteroid therapy
✕. History of trophoblastic disease

What they're measuring

Resolution of pregnancy loss

Timeframe: 7 Days

Trial details

NCT IDNCT06121063

SponsorConceptra Biosciences, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-15

View on ClinicalTrials.gov More Early Pregnancy Loss, Delayed Pregnancy Loss trials