Prospective, Observational, Single center study to evaluate the foeto-maternal outcomes in Premature Rupture of Membranes and Preterm Premature Rupture of Membranes.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Maternal and neonatal outcomes will be monitored from admission until discharge, including maternal complications such as chorioamnionitis, postpartum hemorrhage, maternal sepsis, and cesarean delivery, as well as neonatal outcomes like sepsis, NICU admissions, low Apgar scores, preterm birth, respiratory distress syndrome, and perinatal mortality.
研究概览
简要总结
This is a prospective, observational, single-center study conducted at Bhaktivedanta Hospital and Research Centre, Thane, Maharashtra, aimed at evaluating maternal and neonatal outcomes in pregnancies complicated by Premature Rupture of Membranes (PROM) and Preterm PROM (PPROM). The study will include 86 pregnant women with singleton pregnancies and gestational age more than or equal to 28 weeks who present with spontaneous rupture of membranes before the onset of labor. Participants will be monitored from admission through delivery and postpartum, with data collected on maternal complications (e.g., chorioamnionitis, postpartum hemorrhage, sepsis), neonatal outcomes (e.g., birth weight, Apgar scores, NICU admission, neonatal sepsis), and interventions such as prophylactic antibiotics and corticosteroids. The study will also compare outcomes between term PROM (more than or equal to37 weeks) and preterm PROM (Less then 37 weeks). The findings aim to inform better clinical management and reduce maternal and neonatal morbidity associated with PROM.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women with confirmed PROM (spontaneous rupture of membranes before the onset of labor).
- •Singleton pregnancies.
- •Gestational age more then or equal to 28 weeks.
- •Women willing to participate and provide informed consent.
排除标准
- •Gestational age less than 28 weeks
- •Post caesarean pregnancy
- •Multiple pregnancies
- •Malpresentation
- •Ante partum haemorrhage
- •Meconium stained liquor
- •Congenital anomalies
- •Pregnant women with pre-existing maternal infections (e.g., HIV, active tuberculosis).
结局指标
主要结局
Maternal and neonatal outcomes will be monitored from admission until discharge, including maternal complications such as chorioamnionitis, postpartum hemorrhage, maternal sepsis, and cesarean delivery, as well as neonatal outcomes like sepsis, NICU admissions, low Apgar scores, preterm birth, respiratory distress syndrome, and perinatal mortality.
时间窗: 1 hour after the admission, 1 hour before discharge
次要结局
- 1. Duration from PROM to delivery & its impact on maternal & neonatal outcomes.(2. Mode of delivery (vaginal vs. cesarean section) & associated maternal morbidity.)
研究者
DR Vaishali Choudhri
Bhaktivedanta hospital and Research institute