Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Number of participants who will deliver before 34 weeks gestation.
研究概览
简要总结
This is a double blinded randomized placebo controlled clinical trial to detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.
详细描述
The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1), or vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants and investigators
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of any age
- •Healthy singleton pregnancy
- •History suggestive of one or more previous PTB
- •Current pregnancy (16-20) weeks gestation.
排除标准
- •Multifetal pregnancy.
- •History of ante partum PROM.
- •Cervical Incompetence or current cervical cerclage.
- •Known fetal anomaly.
- •Hypertension requiring medications.
- •History of Thrombo-embolic disorders.
- •Known allergy to progesterone or asprin.
- •Known liver disease.
- •Established preterm labor
- •Short cervix
研究组 & 干预措施
Progesterone with asprin
The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1),
干预措施: Aspirin tablet (Drug)
Progesterone and placebo
vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants who will deliver before 34 weeks gestation.
时间窗: 18 month
Number of participants who have preterm delivery before 34 weeks gestation
次要结局
- The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation(18 months)
- Neonatal outcomes(18 months)
研究者
Mohamed Maher
Professor
Menoufia University