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History of Changes for Study: NCT03309735
Non-interventional Study of Therapy for Threatened Miscarriage
Latest version (submitted January 17, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 10, 2017 None (earliest Version on record)
2 October 18, 2017 Recruitment Status, Study Status and Contacts/Locations
3 October 31, 2017 Contacts/Locations and Study Status
4 November 27, 2017 Study Status and Contacts/Locations
5 January 17, 2018 Recruitment Status, Study Status, Contacts/Locations, Study Design
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Study NCT03309735
Submitted Date:  January 17, 2018 (v5)

Open or close this module Study Identification
Unique Protocol ID: 0717-1
Brief Title: Non-interventional Study of Therapy for Threatened Miscarriage
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2018
Overall Status: Completed
Study Start: October 16, 2017
Primary Completion: December 22, 2017 [Actual]
Study Completion: December 22, 2017 [Actual]
First Submitted: October 5, 2017
First Submitted that
Met QC Criteria:
October 10, 2017
First Posted: October 16, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
January 17, 2018
Last Update Posted: January 18, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Besins Healthcare
Responsible Party: Sponsor
Collaborators: Clinical Research Laboratory, CRO, Russia
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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 (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).

Open or close this module Conditions
Conditions: Threatened Miscarriage
Keywords: threatened miscarriage
miscarriage
micronized progesterone
dydrogesterone
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Other
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 1241 [Actual]
Number of Groups/Cohorts 3
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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
Drug: Micronized progesterone
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
2
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

Other Names:
  • Utrogestan
3
Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear
Drug: Dydrogesterone
Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear

Other Names:
  • Duphaston
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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)]
Secondary Outcome Measures:
2. 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)]
3. Duration of hospitalization
Duration of hospitalization

[Time Frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)]
4. 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)]
5. 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)]
Other Pre-specified Outcome Measures:
6. 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)]
Open or close this module Eligibility
Study Population: Women aged 18-35 years with a confirmed threat of miscarriage with a gestation period of 8 to 22 full weeks.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 35 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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;
Open or close this module Contacts/Locations
Study Officials: Igor Manuhin, PhD
Principal Investigator
Moscow State University of Medicine and Dentistry named after A.I. Evdokimov
Locations: Russian Federation
City Clinical Hospital №68
Moscow, Russian Federation, 109263
Pirogov Russian National Research Medical University (RNRMU)
Moscow, Russian Federation, 117997
Maternity hospital №17
Moscow, Russian Federation, 127247
Russian Federation, Bashkortostan Republic
City Clinical Hospital of the Demsk District
Ufa, Bashkortostan Republic, Russian Federation, 450000
Russian Federation, Krasnoyarsk Region
Maternity hospital №1
Krasnoyarsk, Krasnoyarsk Region, Russian Federation, 660000
Russian Federation, Kursk Region
Regional perinatal center
Kursk, Kursk Region, Russian Federation, 305000
Russian Federation, Moscow Region
Chekhov district hospital №1
Chekhov, Moscow Region, Russian Federation, 142300
Central district hospital
Zhukovsky, Moscow Region, Russian Federation, 140180
Russian Federation, Novosibirsk Region
Center for Family Planning and Reproduction
Novosibirsk, Novosibirsk Region, Russian Federation, 630000
Russian Federation, Omsk Region
Maternity hospital №2
Omsk, Omsk Region, Russian Federation, 644000
Maternity hospital №6
Omsk, Omsk Region, Russian Federation, 644000
Russian Federation, Republic Of Tatarstan
City Clinical Hospital №16
Kazan, Republic Of Tatarstan, Russian Federation, 420000
Russian Federation, Samara Region
Сity hospital №7
Samara, Samara Region, Russian Federation, 443000
Russian Federation, Stavropol Region
Stavropol Central District Hospital
Stavropol, Stavropol Region, Russian Federation, 445004
Russian Federation, Sverdlovsk Region
Сentral city hospital
Kamensk-Uralsky, Sverdlovsk Region, Russian Federation, 623400
Russian Federation, Voronezh Region
City Clinical Hospital № 8
Voronezh, Voronezh Region, Russian Federation, 394000
Russian Federation, Yaroslavl Region
Regional Perinatal Center
Yaroslavl, Yaroslavl Region, Russian Federation, 150042
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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