Progesterone Supplementation in Threatened Abortion: Is it a Sound Practice?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- relief of pain
研究概览
简要总结
To decide whether progesterone supplementation in threatened abortion is a sound practice.
详细描述
This study was conducted at Obstetrics and Gynecology Department, Tanta University in the period from January 2018 to December 2018. Patients: Eligible patients (n=190) were randomly allocated into 2 groups; study group who will receive progesterone supplementation (Prog.group) and control group who will receive no treatment (place.group).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •threatened abortion diagnosed by history and ultrasound examination
- •singleton
- •viable fetus
- •gestational age < 20 weeks
- •closed normal length cervix.
排除标准
- •short cervix <2 cm Multiple pregnancy
- •dead fetus
- •open cervix ≥ 2cm
- •history of cervical surgery
- •refusal to participate.
研究组 & 干预措施
Progesterone
received rectal progesterone suppositories 400 mg once daily
干预措施: Progesterone (Drug)
Control group
received placebo suppositories rectally once daily.
干预措施: Placebos (Drug)
结局指标
主要结局
relief of pain
时间窗: 3 weeks
questionnaire fulfilled by patient with yes or no questions
Stoppage of bleeding
时间窗: 3 weeks
Cessation of bleeding
completion of pregnancy beyond 20 weeks
时间窗: 12 weeks
passing the age 20 weeks
次要结局
- abortion less than 20 weeks.(12 weeks)
研究者
Ayman S Dawood, MD
Lecturer
Tanta University