Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Preterm labor before 34 weeks
研究概览
简要总结
To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix
详细描述
Women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24 weeks gestational age without symptoms, signs or other risk factors of preterm labor will be included in the study. All women will be randomly divided into two groups; one group (study group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 20-24 weeks gestational age (study group) and the other group received no treatment (control group)
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
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women pregnant in dichorionic twins.
- •Transvaginal sonographic cervical length is 20-25 mm at 20-24 weeks gestational age.
- •No symptoms, signs or other risk factors for preterm labor.
排除标准
- •Age < 20 years or > 35 years.
- •Known allergy or contraindication (relative or absolute) to progesterone therapy.
- •Pregnancy by in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI).
- •Monochorionic twins.
- •Known major fetal structural or chromosomal abnormality.
- •Intrauterine death of one fetus or death of both fetuses.
- •Fetal reduction in current pregnancy.
- •Cervical cerclage in current pregnancy.
- •Medical conditions that may lead to preterm delivery.
- •Rupture of membranes.
- •Vaginal bleeding.
研究组 & 干预措施
Progesterone group
Women received vaginal progesterone suppositories
干预措施: Progesterone (Drug)
结局指标
主要结局
Preterm labor before 34 weeks
时间窗: Up to 34 weeks gestational age
次要结局
- Neonatal respiratory distress syndrome (RDS)(At birth)
- Early neonatal death (END).(One month after birth)
研究者
Mohamed Sayed Abdelhafez
Dr
Mansoura University