An observational study in Threatened Miscarriage, sponsored by Besins Healthcare. Completed at 17 sites in Russian Federation. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-01-18.
Sponsored by Besins Healthcare · Observational
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)
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 pregnant women diagnosed with threatened miscarriage) due to the threat of miscarriage when the inclusion/exclusion criteria are met (women aged 18-35 years with a confirmed threat of miscarriage with a gestation period of 8 to 22 full weeks). Depending on the chosen therapy tactics (this therapy is routine in Russia), all patients are allocated to one of the three study groups:
Group I receives Utrogestan (micronized progesterone), 200 mg orally thrice a day until acute symptoms of the threat of termination of pregnancy (scarlet discharge from the genital tract, pain in the abdomen) and then Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed; Group II receives Utrogestan (micronized progesterone) vaginally 200 mg twice a day and 200 mg orally once a day before bed; Group III receives Duphaston (Dydrogesterone), orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear.
Visit 2 (on the third day of the study/hospitalization). If pregnancy is interrupted earlier, Visit 3 is made.
Visit 3 (on the day of discharge from the hospital: with prolonged or interrupted pregnancy)
Routine clinical procedures (accepted in Russia) will be performed during the study:
Efficacy will be evaluated using primary and secondary efficacy endpoints.
Primary efficacy endpoint:
Secondary efficacy endpoint:
Criteria for safety evaluation:
21 studies on the registry are indexed under Abortion, Threatened; 1 is open to participants now.
This study's enrollment of 1,241 is above the median of 135 across 10 observational studies indexed under Abortion, Threatened.
Browse Abortion, Threatened studies →Besins Healthcare is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women aged 18-35 years with a confirmed threat of miscarriage with a gestation period of 8 to 22 full weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Utrogestan, 200 mg orally thrice a day until acute symptoms of the threat of termination of pregnancy (scarlet discharge from the genital tract, pain in the abdomen) and then Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
Drug: Micronized progesterone
Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
Drug: Micronized progesterone
Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear
Drug: Dydrogesterone
Utrogestan, 200 mg orally thrice a day until acute symptoms of the threat of termination of pregnancy (scarlet discharge from the genital tract, pain in the abdomen) and then Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
Also known as: Utrogestan
Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
Also known as: Utrogestan
Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear
Also known as: Duphaston
Prolongation of pregnancy
Discharge from the hospital with prolonged pregnancy
Time frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Speed of arrest of acute symptoms of threatened miscarriage
Speed of arrest of symptoms of threatened miscarriage (blood discharge from the genital tract and drawing pains in the lower abdomen)
Time frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Duration of hospitalization
Duration of hospitalization
Time frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Severity of patient's condition
Severity of patient's condition dynamically in the course of therapy
Time frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Psycho-emotional status of patients
Psycho-emotional status of women dynamically in the course of therapy
Time frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Evaluation of AE/SAE
All adverse events (AE) and serious adverse events (SAE) will be recorded during the study
Time frame: From the moment of signing of informed consent through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Dec 2017, 2 months.
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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Besins Healthcare