Non-interventional Study of Therapy for Threatened Miscarriage

January 17, 2018 updated by: Besins Healthcare

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)

Study Overview

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

Enrollment (Actual)

1241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Moscow, Russian Federation, 109263
        • City Clinical Hospital №68
      • Moscow, Russian Federation, 117997
        • Pirogov Russian National Research Medical University (RNRMU)
      • Moscow, Russian Federation, 127247
        • Maternity hospital №17
    • Bashkortostan Republic
      • Ufa, Bashkortostan Republic, Russian Federation, 450000
        • City Clinical Hospital of the Demsk District
    • Krasnoyarsk Region
      • Krasnoyarsk, Krasnoyarsk Region, Russian Federation, 660000
        • Maternity hospital №1
    • Kursk Region
      • Kursk, Kursk Region, Russian Federation, 305000
        • Regional perinatal center
    • Moscow Region
      • Chekhov, Moscow Region, Russian Federation, 142300
        • Chekhov district hospital №1
      • Zhukovsky, Moscow Region, Russian Federation, 140180
        • Central District Hospital
    • Novosibirsk Region
      • Novosibirsk, Novosibirsk Region, Russian Federation, 630000
        • Center for Family Planning and Reproduction
    • Omsk Region
      • Omsk, Omsk Region, Russian Federation, 644000
        • Maternity hospital №2
      • Omsk, Omsk Region, Russian Federation, 644000
        • Maternity hospital №6
    • Republic Of Tatarstan
      • Kazan, Republic Of Tatarstan, Russian Federation, 420000
        • City Clinical Hospital №16
    • Samara Region
      • Samara, Samara Region, Russian Federation, 443000
        • Сity hospital №7
    • Stavropol Region
      • Stavropol, Stavropol Region, Russian Federation, 445004
        • Stavropol Central District Hospital
    • Sverdlovsk Region
      • Kamensk-Uralsky, Sverdlovsk Region, Russian Federation, 623400
        • Сentral city hospital
    • Voronezh Region
      • Voronezh, Voronezh Region, Russian Federation, 394000
        • City Clinical Hospital № 8
    • Yaroslavl Region
      • Yaroslavl, Yaroslavl Region, Russian Federation, 150042
        • Regional perinatal center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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)
Discharge from the hospital with prolonged pregnancy
Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)

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)
Speed of arrest of symptoms of threatened miscarriage (blood discharge from the genital tract and drawing pains in the lower abdomen)
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)
Duration of hospitalization
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)
Severity of patient's condition dynamically in the course of therapy
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)
Psycho-emotional status of women dynamically in the course of therapy
Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)

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)
All adverse events (AE) and serious adverse events (SAE) will be recorded during the study
From the moment of signing of informed consent through study completion (until the date of patient discharge from hospital, an averade 7-14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Igor Manuhin, PhD, Moscow State University of Medicine and Dentistry named after A.I. Evdokimov

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2017

Primary Completion (Actual)

December 22, 2017

Study Completion (Actual)

December 22, 2017

Study Registration Dates

First Submitted

October 5, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (Actual)

October 16, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 17, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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