Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT03309735
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent of the patient to participate in the study;
* Women aged 18-35 years;
* Progressive uterine pregnancy at the time of inclusion in the study from 8 to 22 full weeks;
* Drawing pains in the lower abdomen, lumbar region;
* Scanty blood discharge from the genital tract;
* Palpitation of the fetus revealed by ultrasound;
* Prescription by attending physician of Utrogestan or Duphaston, depending on chosen treatment tactics.
A physician should decide on the therapy, as well as tactics of further management of pregnancy before the patient is enrolled in the study and regardless of it.
Exclusion Criteria:
* Stimulated ovulation, use of assisted reproductive technologies;
* Abnormalities in the structure of the uterus;
* Amputation of the cervix;
* Uterine myoma with submucosal location of the node (a clinically significant size);
* Karyotype anomalies of parents (if applicable);
* Aneuploidy, anembrion, fetal malformations, as established causes of loss of previous pregnancies;
* Congenital thrombophilia: factor V gene mutation (Leiden mutation), mutation of the prothrombin gene (if applicable);
* Non-developing pregnancy;
* Other clinically significant causes of miscarriage identified during examination (including but not limited to): pre-pregnancy diabetes, pre-pregnancy uncompensated thyroid dysfunction, history of malignant tumors or current tumors, psychiatric illnesses;
* STDs at the time of inclusion in the study;
* Administration of enzyme-inducing medicinal products (anticonvulsants, antipsychotics, antidepressants, tranquilizers), use of psychoactive substances before and during pregnancy;
* Multiple pregnancy;
* Patients previously included in this study, but who withdrew from the study for any reason;
* Contraindications to therapy with Utrogestan and Duphaston, listed in approved prescribing instructions;
* Contraindications to pregnancy prolongation;
* Any other clinical conditions that, as seen by investigator, contradict inclusion criteria, may lead to the early termination of the patient's participation in the study or make it difficult to interpret the results of the latter;
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT03309735
Study Brief:
Protocol Section:
NCT03309735