Comparison of Effect of Antenatal Dexamethasone Versus Betamethasone on Antepartum Cardiactocography
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Mean number of accelerations on fetal cardiotocography
研究概览
简要总结
As baby grows inside the womb of mother, heart and other organs develop. The heart activity can be recorded by placing a transducer on the belly of mother. The tracing obtain provides information about heart rate, any increase or decrease in heart rate and how much it varies with time. Variation in heart rate along with increase is indicator of fetal well being. Some mothers are at high risk of pre-term birth that is baby delivery before 37 weeks of gestation. In such cases steroids are given to mother to accelerate lung development of the baby so that it can easily adapt to outside world. Dexamethasone and Betamethasone are commonly used steroids which can also effect fetal heart activity.
详细描述
Some patients are at high risk of Pre term birth and therefore they are advised antenatal steroids which facilitates fetal lung development preparing it for smoother transition for extra-uterine life. Dexamethasone and Betamethasone are commonly used for this purpose but differently effect fetal cardiac activity as evident by CTG changes and awareness of these phenomena would prevent iatrogenic delivery of preterm fetuses.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be randomly divided into two groups using computer generated numbers and will be masked to the treatment they receive. The person assessing outcome i.e. fetal cardiotography activity will be masked to the treatment participant received.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •History of pre term labor
- •Preterm pre labor rupture of membranes
- •Third trimester bleeding due to placenta previa
排除标准
- •Uteroplacental insufficiency
- •Oligohydroamnios
- •Maternal drug therapy that can effect fetal heart rate
- •Contraindications to Intramuscular injections
- •Patients admitted with non reassuring CTG
研究组 & 干预措施
Group Betamethasone
Intramuscular injection of Betamethasone 12mg will be administered on 2 consecutive days
干预措施: Betamethason Sodium Phosphate (Drug)
Group Dexmaethasone
24mg of Dexamethasone in two divided doses will be given Intramuscularly over 24 hours apart
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Mean number of accelerations on fetal cardiotocography
时间窗: Before intervention, 2 and 4 days after intervention
Long term heart rate variability on fetal cardiotocography
时间窗: Before intervention, 2 and 4 days after intervention
次要结局
未报告次要终点
研究者
Ifra Shafique
Principal Investigator
Rawalpindi Medical College