Does a Repeat Course of Antenatal Corticosteroids in Pregnant Women With Preterm Premature Rupture of Membranes Decrease Neonatal Morbidity?
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Length of stay in the neonatal intensive care unit (NICU)
研究概览
简要总结
The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity associated with this condition.
详细描述
While the fetal benefits of a repeat course of antenatal corticosteroids have been demonstrated in several randomized controlled studies, to the investigators' knowledge they have not been adequately demonstrated in women with PPROM. Given the potential benefit of a repeat course of antenatal corticosteroids in women with PPROM on decreasing neonatal morbidity and the reassuring data from various cohorts on its safety, the investigators sought to propose a randomized controlled trial (RCT) with the hypothesis that a repeat course of antenatal corticosteroids in women with PPROM decreases neonatal morbidity.
Objectives
- To evaluate the impact of maternal treatment with a second course of betamethasone on infant length of stay in the NICU.
- To evaluate the impact of maternal treatment with a second course of betamethasone on the duration of neonatal need for oxygen supplementation.
- To evaluate the impact of maternal treatment with a second course of betamethasone on neonatal morbidity overall.
Hypotheses The investigators hypothesize that treatment of women with PPROM between 24 and 34 weeks of gestation with a repeat course of antenatal corticosteroids decreases infant length of stay in the NICU and neonatal morbidity.
Aim To describe and compare the neonatal outcomes of PPROM infants exposed to a repeat course of antenatal corticosteroids compared to infants in the same antenatal conditions who are exposed to only one betamethasone course.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Maternal age ≥ 18 years
- •Preterm premature rupture of membranes, demonstrated clinically by speculum exam
- •Cervical dilation visually ≤ 5cm on sterile speculum exam
- •Planned delivery at John Sealy Hospital (JSH)
- •Gestational age of membrane rupture and initiation of first course of antenatal corticosteroids between 23 5/7 - 32 5/7 weeks
- •Planned pregnancy continuation with no indication for delivery for at least 7 days
排除标准
- •Maternal age > 50 years
- •Gestational age < 23 5/7 weeks or > 32 5/7 weeks
- •Known major congenital abnormalities, aneuploidy, or genetic syndrome
- •Intrauterine fetal demise
- •Any indication for expedited delivery
- •Maternal chorioamnionitis
- •Known allergy or adverse reaction to corticosteroids
研究组 & 干预措施
Betamethasone
Women admitted with PPROM who will receive a second course of two betamethasone 12mg intramuscular (IM) injections given 24 hours apart.
干预措施: Betamethasone (Drug)
Saline Placebo
Women admitted with PPROM who will receive intramuscular saline placebo, given as two injections 24 hours apart.
干预措施: Placebo (Drug)
结局指标
主要结局
Length of stay in the neonatal intensive care unit (NICU)
时间窗: daily from birth of infant up to one year
expressed in days
Average Number of Days in the Neonatal Intensive Care Unit (NICU)
时间窗: daily from birth of infant up to one year or discharge from the NICU, whichever occurred first
Mean number of days participants remained admitted to the Neonatal Intensive Care Unit (NICU) during hospitalization following birth.
次要结局
- Composite neonatal morbidity(assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first)
- Duration of oxygen and ventilatory support(assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first)
- Development of Respiratory Distress Syndrome (RDS)(assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first)
- Grade III or IV intraventricular hemorrhage (IVH)(assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first)
- Neonatal Sepsis(daily up to 72 hours of life)
- Necrotizing enterocolitis (NEC) stage 2 or 3(assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first)
- Perinatal death(assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first)
- Number of Participants With Composite Neonatal Morbidity(assessed daily up to 120 days after birth or discharge from hospital, whichever occured first)
- Number of Perinatal Death(s)(assessed daily up to 120 days after birth or discharge from hospital, whichever occurred first)
- Average Number of Days Requiring Supplemental Oxygen or Ventilatory Support(daily from birth until discharge from the NICU or up to 1 year of age, whichever occurred first.)
- Number of Participants Who Developed Respiratory Distress Syndrome (RDS)(assessed daily up to 120 days after birth or discharge from hospital, whichever occurred first)
- Grade III or IV Intraventricular Hemorrhage (IVH)(assessed daily up to 120 days after birth or discharge from hospital, whichever occurred first)
- Number of Participants With Neonatal Sepsis(daily up to 72 hours of life)
- Number of Participants With Necrotizing Enterocolitis (NEC) Stage 2 or 3(assessed daily up to 120 days after birth or discharge from hospital, whichever occurred first)