A Randomised Controlled Feasibility Study of the Tolerability of the Combination of Progesterone and Aminophylline for the Prevention of Preterm Labour
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To assess number of women at high risk of Preterm Labour (PTL) withdraw from the combination therapy of Progesterone (P4) and aminophylline due to side effects, in comparison to P4 alone.
研究概览
简要总结
The aim of this study is to investigate whether the combination of aminophylline and Progesterone (P4) is acceptable to women at high-risk of Pre-term labour (PTL). If this proves to be the case, a larger double blind, randomised controlled trial will be conducted to test the hypothesis that the combination of P4 and aminophylline reduces the risk of PTL more effectively than P4 alone.
The study is a randomised study where participants will be either administered a combination of aminophylline and Progesterone (P4) or Progesterone (P4) alone.As the study is open label, the participants and the study doctor will know which study medications the participant is taking at all times during the study.
详细描述
Name of Investigational Product: Cyclogest® 400 mg, Phyllocontin® Continus®
Name of active ingredients:Progesterone PhEur 400 mg, Aminophylline hydrate 225 mg
Phase of study: Phase I
Primary Objectives:
- To assess how many women at high risk of Preterm Labour (PTL) withdraw from the combination therapy of Progesterone (P4) and aminophylline due to side effects in comparison to P4 alone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women between 13 and 20 weeks of gestation.
- •Singleton pregnancy.
- •Intact fetal membranes at the time of recruitment.
- •The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
- •Obstetric history: previous mid-trimester loss (14 - 26 weeks) and preterm delivery (< 37 weeks).
- •Women with a history of indicated cervical suture.
- •Short cervical length (≤ 25 mm) on ultrasound at 13-20+0 weeks gestation, with or without a cervical suture and with or without a positive fetal fibronectin.
- •Women must be aged 18 years or older.
排除标准
- •Known sensitivity, contraindication or intolerance to P4 (History of liver tumours, severe liver impairment, genital or breast cancer, severe arterial disease, undiagnosed vaginal bleeding, acute porphyria, history during pregnancy of idiopathic jaundice, severe pruritus or pemphigoid gestations)
- •Known sensitivity, contraindication or intolerance to aminophylline (hypokalaemia, pre-existing cardiac arrhythmias, epilepsy, hyperparathyroidism, peptic ulcer disease)
- •Suspected or proven rupture of the fetal membranes at the time of recruitment.
- •Prescription or ingestion of medications known to interact with P4 (e.g Bromocriptine, carbamazepine, diazepam, lorazepam and temazepam, insulin).
- •Aminophylline plasma concentrations can be increased in the presence of: acyclovir, calcium channel blockers, cimetidine, erythromycin, clarithromycin, corticosteroids and benzodiazepine, carbamazepine, beta-sympathomimetics.
- •Evidence of maternal infection or sepsis (maternal temperature ≥37.5C, increased inflammatory markers - WBC, CRP).
- •Multiple pregnancy.
- •Known significant congenital structural or chromosomal fetal anomaly.
- •Maternal pathologies in which preterm termination of pregnancy is required.
- •Pre-eclampsia or severe hypertension.
研究组 & 干预措施
Progesterone alone
Progesterone 400 mg once daily until 34 weeks.
干预措施: Progesterone (Drug)
Progesterone and aminophylline.
Progesterone 400 mg and aminophylline 225 mg once daily until 34 weeks.
干预措施: Progesterone (Drug)
Progesterone and aminophylline.
Progesterone 400 mg and aminophylline 225 mg once daily until 34 weeks.
干预措施: Aminophylline (Drug)
结局指标
主要结局
To assess number of women at high risk of Preterm Labour (PTL) withdraw from the combination therapy of Progesterone (P4) and aminophylline due to side effects, in comparison to P4 alone.
时间窗: 34 weeks
Tolerability will be assessed by the number of participants who withdraw from the study due to severe adverse side effects at each safety visit (14, 16, 18, 22, 26, 30 and 34 weeks of pregnancy).
次要结局
- To assess the effect on the maternal immune system.(34 weeks)
- The number of women who deliver before 34 weeks.(34 weeks)
- The impact on preterm delivery and episodes of threatened Preterm Labour(34 weeks)