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Non-interventional Study of Therapy for Threatened Miscarriage

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ClinicalTrials.gov Identifier: NCT03309735
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Clinical Research Laboratory, CRO, Russia
Information provided by (Responsible Party):
Besins Healthcare

Tracking Information
First Submitted Date October 5, 2017
First Posted Date October 16, 2017
Last Update Posted Date January 18, 2018
Actual Study Start Date October 16, 2017
Actual Primary Completion Date December 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 10, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 10, 2017)
  • 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) ]
    Speed of arrest of symptoms of threatened miscarriage (blood discharge from the genital tract and drawing pains in the lower abdomen)
  • Duration of hospitalization [ Time Frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days) ]
    Duration of hospitalization
  • Severity of patient's condition [ Time Frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days) ]
    Severity of patient's condition dynamically in the course of therapy
  • Psycho-emotional status of patients [ Time Frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days) ]
    Psycho-emotional status of women dynamically in the course of therapy
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 10, 2017)
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) ]
All adverse events (AE) and serious adverse events (SAE) will be recorded during the study
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
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)
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).

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women aged 18-35 years with a confirmed threat of miscarriage with a gestation period of 8 to 22 full weeks.
Condition Threatened Miscarriage
Intervention
  • 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 Name: Utrogestan
  • Drug: Micronized progesterone
    Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
    Other Name: Utrogestan
  • Drug: Dydrogesterone
    Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear
    Other Name: Duphaston
Study Groups/Cohorts
  • 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
    Intervention: Drug: Micronized progesterone
  • 2
    Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
    Intervention: Drug: Micronized progesterone
  • 3
    Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear
    Intervention: Drug: Dydrogesterone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 17, 2018)
1241
Original Estimated Enrollment
 (submitted: October 10, 2017)
1500
Actual Study Completion Date December 22, 2017
Actual Primary Completion Date December 22, 2017   (Final data collection date for primary outcome measure)
Eligibility 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;
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT03309735
Other Study ID Numbers 0717-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Besins Healthcare
Study Sponsor Besins Healthcare
Collaborators Clinical Research Laboratory, CRO, Russia
Investigators
Principal Investigator: Igor Manuhin, PhD Moscow State University of Medicine and Dentistry named after A.I. Evdokimov
PRS Account Besins Healthcare
Verification Date January 2018