Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-02 @ 1:46 AM
Study NCT ID:
NCT03309735
Status:
COMPLETED
Last Update Posted:
2018-01-18
First Post:
2017-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Study of Therapy for Threatened Miscarriage
Sponsor:
Besins Healthcare
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: