Efficacy of Prophylactic Vaginal Progesterone in Prevention of Preterm Delivery in Women With Placenta Previa
试验速览
- 阶段
- 2 期
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Incidence of preterm delivery due to severe antepartum hemorrhage.
研究概览
简要总结
This study evaluates the efficacy of prophylactic vaginal progesterone administration in reducing of the episodes of antepartum hemorrhage and subsequent prevention of preterm delivery in women with placenta previa.
详细描述
Eligible women who consent to participate in the study are randomly allocated into one of the two study groups. Women who are allocated to the study group will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer); while the other group will serve as controls. Patients will be followed up till delivery for the incidence in antepartum hemorrhagic episodes.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age 26-28 weeks of gestation.
- •Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan.
排除标准
- •Multiple pregnancy.
- •Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabor rupture of the membranes (PPROM).
- •Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
- •Women who have been maintained on progestin therapy since early pregnancy for whatever reason.
研究组 & 干预措施
Vaginal progesterone group
Women will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer).
干预措施: Vaginal progesterone (Drug)
结局指标
主要结局
Incidence of preterm delivery due to severe antepartum hemorrhage.
时间窗: from 26 weeks till 37 weeks
Number of patients who delivered before 37 weeks gestational age
次要结局
- Need for blood transfusion.(from 26 weeks till 37 weeks)
- Incidence of severe postpartum hemorrhage.(from 26 weeks till 37 weeks)
- No. of episodes of antepartum hemorrhage.(from 26 weeks till 37 weeks)
- Incidence of Cesarean hysterectomy.(from 26 weeks till 37 weeks)
- Patient compliance(from 26 weeks till 37 weeks)
- Patient satisfaction: Likert Scale(from 26 weeks till 37 weeks)
- Neonatal Birth weight.(At birth)
- Need for NICU admission and its duration.(At birth)
- Respiratory morbidity (transient tachypnea or respiratory distress syndrome).(At birth)
- Hospital admission for significant antepartum hemorrhage.(from 26 weeks till 37 weeks)
- Hospital admission for threatened preterm labor.(from 26 weeks till 37 weeks)
- Prematurity-related mortality.(28 days postpartum)
研究者
mohammed mahmoud samy
Lecturer in Obstetrics and Gynecology
Ain Shams University