A prospective, observational study to compare the patient reported outcomes with the use of oral dydrogesterone vs. micronized vaginal progesterone in high risk pregnancies (PERCEPT study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- 1.Patient reported adverse events:
研究概览
简要总结
The objective ofthe study is to compare oral dydrogesterone vs. micronized vaginal progesteronein high risk pregnancies in terms of patient reported outcomes, treatmentcompliance, proportion of patients switched to other treatment during the studyperiod and to understand the utilization pattern.
The outcomevariables like treatment details, patient reported adverse events, patientexperience and treatment compliance will be recorded at week 4 and week 8. Datafrom the CRFs will be entered in a Microsoft Excel Sheet and analyzed.Intention to treat analysis approach will be followed. Descriptive statisticswill be calculated. Categorical data will be represented in frequencies,percentages. Quantitative data will be described as Mean ± SD. Data within thegroup at more than 2 time intervals will be compared using Repeated measuresANOVA (for normally distributed data) or Friedman’s test (for data which is notnormally distributed), followed by pairwise comparisons for significantdifferences. The level of significance in the study will be < 0.05 and 95%confidence intervals will be used to assess its significance
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Pregnant women with age of ≥ 18 years and who are ready to give informed consent for participation in the study.
- •2.Women with clinically diagnosed pregnancy of ≤ 12 weeks of gestation and visiting department of obstetrics and gynecology.
- •3.History of more than two miscarriages and/or presenting with vaginal bleeding 4.Patient suitable for treatment with micronized vaginal progesterone or dydrogesterone therapy based on locally approved prescribing information.
排除标准
- •1.Pregnant women who have contraindications for use of micronized vaginal progesterone or dydrogesterone.
- •2.Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study.
结局指标
主要结局
1.Patient reported adverse events:
时间窗: Week 4 and Week 8
o Vulvovaginal symptoms reported: vaginal itching, irritation, burning, discharge and others.
时间窗: Week 4 and Week 8
o Other adverse events reported: Nausea, vomiting, abdominal cramps, gastritis, diarrhoea, constipation headache, fatigue, breast pain or tenderness, muscle, joint or bone pain and others.
时间窗: Week 4 and Week 8
2.Patient experience with the study medication
时间窗: Week 4 and Week 8
次要结局
- Percentage of patients lost to follow up(Week 4 and Week 8)
- Treatment compliance(Week 4 and Week 8)
- Other measures: Obstetric History, Risk factor(s), Co-prescribed Medication(s)(Week 4 and Week 8)
- Utilization pattern: Dose prescribed, Dosing frequency, Duration of treatment(Week 4 and Week 8)
- Percentage of patients switched to other treatment (other type of progesterone)(Week 4 and Week 8)