Status:
COMPLETED
Non-interventional Study of Therapy for Threatened Miscarriage
Lead Sponsor:
Besins Healthcare
Collaborating Sponsors:
Clinical Research Laboratory, CRO, Russia
Conditions:
Threatened Miscarriage
Eligibility:
FEMALE
18-35 years
Brief 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 (Dydrog...
Detailed Description
Open comparative non-interventional study. During the study three visits are planned: Visit 1 (enrollment) is conducted when the patient is hospitalized in a hospital (providing medical care to preg...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
October 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 22 2017
Estimated Enrollment :
1241 Patients enrolled
Trial Details
Trial ID
NCT03309735
Start Date
October 16 2017
End Date
December 22 2017
Last Update
January 18 2018
Active Locations (17)
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1
City Clinical Hospital of the Demsk District
Ufa, Bashkortostan Republic, Russia, 450000
2
Maternity hospital №1
Krasnoyarsk, Krasnoyarsk Region, Russia, 660000
3
Regional perinatal center
Kursk, Kursk Oblast, Russia, 305000
4
Chekhov district hospital №1
Chekhov, Moscow Oblast, Russia, 142300