Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- prolongation of the pregnancy until a favorable gestational age
研究概览
简要总结
The aim of the study is to assess the efficacy of 17-hydroxyprogesterone caproate (17P) therapy on the latency period in pregnant women with Preterm premature rupture of membranes.
详细描述
After taking informed written consent, the recruited patients will be subjected to the following:
- Detailed history
- Personal History: Name, age ,residence ,special habits of medical importance
- Obstetric history: first day of last menstrual period for accurate estimation of gestational age and antenatal care
- Past history: history of any medical disorder or surgical history with particular emphasis on prior PPROM or preterm labor
- History of the present pregnancy: Medical or surgical condition to define high risk pregnancy.
- Examination of the patients General examination: blood pressure, pulse, temperature
Abdominal examination:
-
Inspection: fundal level, scars, umbilicus.
-
Palpation: presence of contractions, fetal lie and presentation.
-
Pelvic Examination only by sterile speculum to exclude cord prolapse , bloody liquor and cervical dilatation and effacement
-
Non stress test to ensure reassuring fetal well being
-
Ultrasound examination to:-
-
Assess fetal viability.
-
Amniotic fluid index.
-
Determine gestational age.
-
Exclude major anomalies.
-
Placental location.
- Baseline laboratory investigations:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Gestational age between 24 and 34 weeks
排除标准
- •Medical or obstetric conditions that could put them at risk for uterine atony , postpartum hemorrhage AND infection, such as
- •Emergency Cesarean section.
- •Chorioamnionitis.
- •Placenta previa.
- •Multiple gestation.
- •Preeclampsia.
- •Macrosomia.
- •Non reassuring fetal status or fetal distress
- •Presence of fetal anomalies incompatable with life
- •Woman with antepartum haemorrhage
- •Diagnosis of Established preterm labor
研究组 & 干预措施
study group
17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume)intramuscular injection
干预措施: 17-hydroxyprogesterone caproate (Drug)
control group
castor oil, 1 mL total volume intramuscular injection
干预措施: Castor Oil (Drug)
结局指标
主要结局
prolongation of the pregnancy until a favorable gestational age
时间窗: 10 to 12 weeks (up to 34.0 weeks of gestation or documentation of fetal lung maturity at 32.0 to 33.9 weeks.)
The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used
次要结局
- Composite neonatal morbidity(1 week (from delivery to 1 week post Natal))
- Latency .(10 to 12 weeks (interval in weeks from randomization to delivery))