- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03309735
Non-interventional Study of Therapy for Threatened Miscarriage
Multicenter Open Prospective Comparative Non-interventional Study of Therapy for Threatened Miscarriage With Medicinal Products Utrogestan, 200 mg Capsules (Besins Healthcare SA, Belgium), and Duphaston, 10 mg Coated Tablets (Abbott Healthcare Products B.V., the Netherlands)
Study Overview
Status
Conditions
Intervention / Treatment
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 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:
- Collection of demographic and anthropometric data (age, height, body weight);
- Collection of complaints, medical and obstetric-gynecological history;
- Measurement of blood pressure, heart rate, respiratory rate and body temperature;
- Gynecological examination with the help of gynecological specula;
- Vaginal bimanual examination;
- Transvaginal ultrasound, determination of viability of uterine pregnancy (determination of embryo/fetal heartbeat);
- Assessment of the severity of the patient's condition according to Clinical Global Impression scale;
- Evaluation of psycho-emotional status dynamically using Zigmond-Snaith Hospital Anxiety and Depression Scale;
Efficacy will be evaluated using primary and secondary efficacy endpoints.
Primary efficacy endpoint:
• Discharge from the hospital with prolonged pregnancy;
Secondary efficacy endpoint:
- Speed of arrest of symptoms of threatened miscarriage (blood discharge from the genital tract and drawing pains in the lower abdomen);
- Duration of hospitalization;
- Severity of patient's condition dynamically in the course of therapy;
- Psycho-emotional status of women dynamically in the course of therapy;
Criteria for safety evaluation:
• Evaluation of AE/SAE. All adverse events (As) and serious adverse events (SAE) will be recorded, starting from the moment of signing of informed consent before the end of participation in the study (before discharge from the hospital).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Moscow, Russian Federation, 109263
- City Clinical Hospital №68
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Moscow, Russian Federation, 117997
- Pirogov Russian National Research Medical University (RNRMU)
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Moscow, Russian Federation, 127247
- Maternity hospital №17
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Bashkortostan Republic
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Ufa, Bashkortostan Republic, Russian Federation, 450000
- City Clinical Hospital of the Demsk District
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Krasnoyarsk Region
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Krasnoyarsk, Krasnoyarsk Region, Russian Federation, 660000
- Maternity hospital №1
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Kursk Region
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Kursk, Kursk Region, Russian Federation, 305000
- Regional perinatal center
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Moscow Region
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Chekhov, Moscow Region, Russian Federation, 142300
- Chekhov district hospital №1
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Zhukovsky, Moscow Region, Russian Federation, 140180
- Central District Hospital
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Novosibirsk Region
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Novosibirsk, Novosibirsk Region, Russian Federation, 630000
- Center for Family Planning and Reproduction
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Omsk Region
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Omsk, Omsk Region, Russian Federation, 644000
- Maternity hospital №2
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Omsk, Omsk Region, Russian Federation, 644000
- Maternity hospital №6
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Republic Of Tatarstan
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Kazan, Republic Of Tatarstan, Russian Federation, 420000
- City Clinical Hospital №16
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Samara Region
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Samara, Samara Region, Russian Federation, 443000
- Сity hospital №7
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Stavropol Region
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Stavropol, Stavropol Region, Russian Federation, 445004
- Stavropol Central District Hospital
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Sverdlovsk Region
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Kamensk-Uralsky, Sverdlovsk Region, Russian Federation, 623400
- Сentral city hospital
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Voronezh Region
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Voronezh, Voronezh Region, Russian Federation, 394000
- City Clinical Hospital № 8
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Yaroslavl Region
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Yaroslavl, Yaroslavl Region, Russian Federation, 150042
- Regional perinatal center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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;
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
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
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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
Other Names:
Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
Other Names:
|
2
Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
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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
Other Names:
Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
Other Names:
|
3
Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear
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Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prolongation of pregnancy
Time Frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
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Discharge from the hospital with prolonged pregnancy
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Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speed of arrest of acute symptoms of threatened miscarriage
Time Frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
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Speed of arrest of symptoms of threatened miscarriage (blood discharge from the genital tract and drawing pains in the lower abdomen)
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Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
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Duration of hospitalization
Time Frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
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Duration of hospitalization
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Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
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Severity of patient's condition
Time Frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
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Severity of patient's condition dynamically in the course of therapy
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Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
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Psycho-emotional status of patients
Time Frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
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Psycho-emotional status of women dynamically in the course of therapy
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Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of AE/SAE
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)
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All adverse events (AE) and serious adverse events (SAE) will be recorded during the study
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From the moment of signing of informed consent through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Igor Manuhin, PhD, Moscow State University of Medicine and Dentistry named after A.I. Evdokimov
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0717-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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