Intramuscular 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Symptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- the duration of prolongation of pregnancy from the time of enrollment to the time of delivery
研究概览
简要总结
Purpose to evaluate the effects of intramuscular 17-Alpha-Hydroxyprogesterone Caproate (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic Pregnant Women with Placenta Previa
详细描述
Most authors report an increased risk of bleeding with advancing gestation among women with placenta previa.
The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) both recommend the use of 17-OHPC to prevent recurrent spontaneous preterm birth.
Preterm deliveries account for 75% of perinatal mortality and surviving preterm infants are at risk for neurological, respiratory, and gastrointestinal complications. So, it is therefore very important to try to prolong the pregnancy without increasing the risk of emergent delivery in cases with placenta previa. The authors hypothesized that a pharmacological strategy like 17-alpha-Hydroxyprogesterone caproate may improve pregnancy outcomes and may also allow obstetricians to tailor their approach to save delayed scheduled cesarean section women with a placenta previa.
The aim of this study to evaluate the role of17-alpha-Hydroxyprogesterone caproate in the prevention of preterm cesarean delivery (CD) in cases with symptomatic placenta previa with avoids of an emergent CD which affects the maternal outcome and prevents prematurity which affects the prenatal outcome.
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
A Double-Blind Randomized Clinical Trial
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Estimated gestational age: between 24 weeks and 37 week's gestation
- •Confirmed Placenta previa; either major or minor degrees.
- •Placenta previa with preterm uterine contractions or with a history of at least single attack of mild vaginal bleeding
排除标准
- •Severe attack of bleeding requiring an immediate intervention.
- •Fetal heart rates instability or non-reassuring tracing
- •Intrauterine fetal death or major fetal anomalies.
- •If associated with abruptio placentae
- •Patients with known bleeding disorders or on anticoagulant therapy
- •Patients with severe medical disorders
研究组 & 干预措施
17-OHPC
patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
干预措施: 17-OHPC (Drug)
placebo to 17-OHPC
patients received weekly placebo to 17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
干预措施: placebo to 17-OHPC (Drug)
结局指标
主要结局
the duration of prolongation of pregnancy from the time of enrollment to the time of delivery
时间窗: 6 weeks
measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery
次要结局
- apgar score(5 minutes postpartum)
- the number of patients with postpartum hemorrhage(24 hours post operative)
研究者
hany farouk
Principal Investigator
Aswan University Hospital