NCT02950935终止3 期
Prospective, Double-blind, Randomised, Placebo Controlled, Phase III Clinical Study Assessing the Efficacy of Natural Progesterone 25 mg/Bid Administered Subcutaneously in the Maintenance of Early Pregnancy in Women With Symptoms of Threatened Abortion
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Ongoing pregnancy rate at 12 weeks of gestation
研究概览
简要总结
The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of threatened abortion. The secondary objectives will be the efficacy of progesterone in reducing both pain and uterine contractions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women attending the emergency room of the study sites with the following characteristics:
- •Able and willing to sign the Subject Informed Consent Form and adhere to the study visit schedule;
- •Age: 18-37 years;
- •BMI: 18-28 kg/m2;
- •Symptoms of threatened abortion (vaginal bleeding , with or without pelvic pain);
- •Ultrasound proof of viable singleton intrauterine pregnancy (positive foetal heart beat);
- •Gestation week ≥6 weeks (5 w +1d) and <12 weeks (11 w + 1d) according to ultrasound dating (CRL);
- •Closed uterine cervix;
- •At the first case of threatened abortion in the current pregnancy.
排除标准
- •Pregnancy obtained via ART treatment;
- •Subchorionic haematoma with >50% placental detachment;
- •History of recurrent miscarriage;
- •Severe uterine malformations;
- •Known hypersensitivity to study medication;
- •Neoplasias (known or suspected breast or genital tract cancer);
- •Severe impairment of hepatic or renal function;
- •Use of concomitant medications that might interfere with study evaluations (other hormonal treatment or drugs affecting uterine contractility);
- •Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events;
- •Porphyria;
- •A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy;
- •Antiphospholipid syndrome;
- •Diabetes mellitus;
- •Known thyroid diseases or autoimmune conditions.
研究组 & 干预措施
Progesterone
Experimental
25 mg of subcutaneous progesterone will be administered twice à day until the 12th week of gestation.
干预措施: Progesterone (Drug)
Placebo
Placebo Comparator
placebo will be administered twice à day until the 12th week of gestation.
干预措施: Placebo (Drug)
结局指标
主要结局
Ongoing pregnancy rate at 12 weeks of gestation
时间窗: 12 weeks
次要结局
- Reduction of the frequency of uterine contractions;(15 days)
- Pain reduction (using a Numerical Rating Scale);(15 days)
- Reduction of subchorionic haematoma;(15 days)
- Number of subjects with onset of new threatened abortion(12 weeks)
研究者
研究点 (4)
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