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Non-interventional Study of Therapy for Threatened Miscarriage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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)

Condition or disease Intervention/treatment
Threatened Miscarriage Drug: Micronized progesterone Drug: Dydrogesterone

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Study Type : Observational
Actual Enrollment : 1241 participants
Observational Model: Other
Time Perspective: Prospective
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)
Actual Study Start Date : October 16, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

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
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

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 Name: 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 Name: Duphaston




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. Duration of hospitalization [ Time Frame: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days) ]
    Duration of hospitalization

  3. 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

  4. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309735


Locations
Show Show 17 study locations
Sponsors and Collaborators
Besins Healthcare
Clinical Research Laboratory, CRO, Russia
Investigators
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Principal Investigator: Igor Manuhin, PhD Moscow State University of Medicine and Dentistry named after A.I. Evdokimov
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Responsible Party: Besins Healthcare
ClinicalTrials.gov Identifier: NCT03309735    
Other Study ID Numbers: 0717-1
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Besins Healthcare:
threatened miscarriage
miscarriage
micronized progesterone
dydrogesterone
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Threatened
Pregnancy Complications
Progesterone
Dydrogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs