Resumen

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).

Age: 18 Years to 50 Years old

Género: Femenino

Fecha de inicio: 07/21/2023

Fecha de finalización principal (estimada): 05/15/2025

Fecha estimada de finalización del estudio: 07/30/2025

Acepta voluntarios sanos: No

Propósito y descripción del ensayo

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.

Criterios de elegibilidad

Age: 18 Years to 50 Years old

Género: Femenino

Acepta voluntarios sanos: No

Criterios de inclusión:

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.

Criterios de exclusión:

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