Threatened MiscarriageNCT03309735
Non-interventional Study of Therapy for Threatened Miscarriage
An observational study of Threatened Miscarriage, run by Besins Healthcare at 17 sites in Russia.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Threatened Miscarriage
- What is being tested?
- Micronized progesterone and Dydrogesterone
- Type of treatment
- Pill or oral medicine
- How many people
- 1,241 participants
- Where
- 17 sitesRussia
- Study dates
- 16 Oct 2017to 22 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 18-35 years with a confirmed threat of miscarriage with a gestation period of 8 to 22 full weeks.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Russia17 sites
Chekhov district hospital №1
Chekhov, Moscow Oblast, 142300
Сentral city hospital
Kamensk-Uralsky, Sverdlovsk Oblast, 623400
City Clinical Hospital №16
Kazan', Tatarstan Republic, 420000
Maternity hospital №1
Krasnoyarsk, Krasnoyarsk Region, 660000
Regional perinatal center
Kursk, Kursk Oblast, 305000
City Clinical Hospital №68
Moscow, 109263
Pirogov Russian National Research Medical University (RNRMU)
Moscow, 117997
Maternity hospital №17
Moscow, 127247
Center for Family Planning and Reproduction
Novosibirsk, Novosibirsk Oblast, 630000
Maternity hospital №2
Omsk, Omsk Oblast, 644000
Maternity hospital №6
Omsk, Omsk Oblast, 644000
Сity hospital №7
Samara, Samara Oblast, 443000
Stavropol Central District Hospital
Stavropol, Stavropol Kray, 445004
City Clinical Hospital of the Demsk District
Ufa, Bashkortostan Republic, 450000
City Clinical Hospital № 8
Voronezh, Voronezh Oblast, 394000
Regional Perinatal Center
Yaroslavl, Yaroslavl Oblast, 150042
Central district hospital
Zhukovsky, Moscow Oblast, 140180
About this study
Official title: 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 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)
Read the 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).
- Conditions
- Threatened Miscarriage
- Being tested
- Micronized progesterone, Dydrogesterone
- Keywords
- threatened miscarriage, miscarriage, micronized progesterone, dydrogesterone
- Medical subject headings
- Abortion, Threatened, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized progesteroneDrug
Also called Utrogestan
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
Micronized progesteroneDrug
Also called Utrogestan
Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
DydrogesteroneDrug
Also called Duphaston
Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Micronized progesterone | |
| 2 | Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed Receives: Drug: Micronized progesterone | |
| 3 | Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear Receives: Drug: Dydrogesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolongation of pregnancy
Discharge from the hospital with prolonged pregnancy
Measured: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Secondary outcomes (4)
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)
Measured: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Duration of hospitalization
Duration of hospitalization
Measured: 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
Measured: 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
Measured: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start16 Oct 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threatened MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Besins Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Laboratory, CRO, Russia
- Responsible party
- Sponsor
- Investigators
- Igor Manuhin, PhD, Principal investigator, Moscow State University of Medicine and Dentistry named after A.I. Evdokimov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309735
- Sponsor's protocol ID
- 0717-1
- Status last verified
- Jan 2018
- First submitted
- 5 Oct 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03309735
- Acronym / sponsor ID
- 0717-1
- Conditions
- Threatened Miscarriage
- Keywords
- threatened miscarriage, miscarriage, micronized progesterone, dydrogesterone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,241 participants (actual)
- Lead sponsor
- Besins HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Research Laboratory, CRO, Russia
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Micronized progesteroneUtrogestan, 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 |
| 2 | – | Drug: Micronized progesteroneUtrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed |
| 3 | – | Drug: DydrogesteroneDuphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 18-35 years with a confirmed threat of miscarriage with a gestation period of 8 to 22 full weeks.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micronized progesteroneAlso: UtrogestanUtrogestan, 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 | 1 |
| Micronized progesteroneAlso: UtrogestanUtrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed | Drug | 2 |
| DydrogesteroneAlso: DuphastonDuphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear | Drug | 3 |
Primary outcome
Prolongation of pregnancy
Time frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Discharge from the hospital with prolonged pregnancy
4 secondary outcomes
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)
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
Time frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Psycho-emotional status of patients
Time frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Threatened Miscarriage
Not yet recruitingObservational study
Serum Progesterone and Threatened Abortion During Lactation
Threatened Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Manuhin, PhD principal investigator
Moscow State University of Medicine and Dentistry named after A.I. Evdokimov
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Threatened Miscarriage, run by Besins Healthcare at 17 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolongation of pregnancy (time frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.