Impact of Enoxaparin Therapy on Fetal Outcomes in Intrauterine Growth Restriction With Oligohydramnios.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Live birth
研究概览
简要总结
The local literature lacks comprehensive information regarding the actual incidence of intrauterine growth restriction (IUGR) and oligohydramnios and currently available therapeutic options. Therefore, the current study was planned with the objective to evaluate the impact of enoxaparin therapy compared with standard management on neonatal outcomes in pregnancies complicated by intrauterine growth restriction (IUGR) with oligohydramnios.
详细描述
The use of enoxaparin is not yet a standard practice in pregnancies with IUGR and oligohydramnios without overt maternal thrombophilia. Given the notable incidence of IUGR and oligohydramnios and the limited therapeutic options currently available, exploring the potential benefits of enoxaparin therapy against standard management is both clinically and socially relevant. By investigating whether enoxaparin can improve fetal outcomes in this high-risk group, the findings of this study would generate evidence that could inform future management protocols, reduce preventable perinatal morbidity and mortality, and ultimately improve neonatal survival and health in Pakistan.
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
- 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
- •Women aged 18-40 years
- •Singleton pregnancy
- •Gestational age ≥28 weeks (confirmed by first-trimester scan or reliable last menstrual period)
- •Diagnosed with both IUGR and oligohydramnios
- •Willing to provide informed written consent
排除标准
- •Multiple gestation
- •Major fetal congenital anomalies
- •Maternal medical disorders affecting pregnancy outcome (e.g., uncontrolled diabetes, chronic hypertension, renal disease)
- •Known coagulation disorders or contraindications to enoxaparin
- •Women already on anticoagulation therapy.
研究组 & 干预措施
Standard Management Group
Patients will continue with standard management alone.
干预措施: Standard Management (Other)
Enoxaparin Group
Patients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery.
干预措施: Enoxaparin (Drug)
Enoxaparin Group
Patients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery.
干预措施: Standard Management (Other)
结局指标
主要结局
Live birth
时间窗: 12 weeks
The frequency of live birth will be noted. Delivery of a baby with signs of life at birth, irrespective of gestational age will be considered as live birth.
Low Birth weight
时间窗: 12 weeks
Frequency of low birth weight will be noted. Neonatal birth weight \<2.5 kg will be documented as low birth weight.
次要结局
- Neonatal Intensive Care Unit Admission(7 days)
- Perinatal Mortality(7 days)
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research