Non-interventional Study of Therapy for Threatened Miscarriage (NCT03309735) | Clinical Trial Compass
CompletedNot Applicable
Non-interventional Study of Therapy for Threatened Miscarriage
Russia1,241 participantsStarted 2017-10-16
Plain-language summary
Study the efficacy and safety of therapy for threatened miscarriage with medicinal products Utrogestan (micronized progesterone), 200 mg capsules (Besins Healthcare SA, Belgium), and Duphaston (Dydrogesterone), 10 mg coated tablets (Abbott Healthcare Products B.V., the Netherlands)
Who can participate
Age range18 Years – 35 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
* Administrat…
What they're measuring
1
Prolongation of pregnancy
Timeframe: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)