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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,241
- 试验地点
- 17
- 主要终点
- Prolongation of pregnancy
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
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
干预措施: Micronized progesterone (Drug)
2
Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
干预措施: Micronized progesterone (Drug)
3
Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear
干预措施: Dydrogesterone (Drug)
结局指标
主要结局
Prolongation of pregnancy
时间窗: Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Discharge from the hospital with prolonged pregnancy
次要结局
- Speed of arrest of acute symptoms of threatened miscarriage(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(Through study completion (until the date of patient discharge from hospital, an averade 7-14 days))
- Psycho-emotional status of patients(Through study completion (until the date of patient discharge from hospital, an averade 7-14 days))