Dexamethasone Effect on Induction Delivery Interval at Term Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- The interval between the initiation of induction and the delivery of the fetus.
研究概览
简要总结
This study aims to evaluate the effect of intravenous injection of a single dose of dexamethasone in shortening the duration interval between initiation of labor induction and delivery of the fetus in primigravida full-term pregnancy.
详细描述
Research hypothesis:
In full term primigravidae undergoing induction of labor, the use of a single dose of dexamethasone (8mg) intra-venously will help in shortening the duration interval between initiation of labor induction and delivery of the fetus.
Research question:
In full term primigravidae undergoing induction of labor, does the use of intra-venous dexamethasone play a role in shortening the duration interval between initiation of labor induction and delivery of the fetus?
Patients and Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparity
- •Singleton pregnancy
- •Gestational age i.e. 40 weeks or more by date or 1sttrimestric ultrasound.
- •Bishop score of 4 or greater.
- •Longitudinal lie.
- •Vertex presentation.
- •Intact membranes
排除标准
- •Refused consent
- •Malpresentation.
- •Multiple pregnancies.
- •Active phase of labour.
- •Rupture of membranes (ROM).
- •Cephalo-pelvic disproportion.
- •Previous C-section or myomectomy operation.
- •Known contraindication or hypersensitivity to Dexamethasone.
- •Fetal distress.
- •Current maternal disorder e.g. diabetes mellitus and pregnancy induced hypertension.
- •Over distended abdomen e.g. fetal macrosomia or polyhydramonus suggested by ultrasound.
- •Ante-partum hemorrhage e.g. placenta previa, accidental hemorrhage.
研究组 & 干预措施
Group P
including 51 women who will receive a prefilled syringe with two milliliters of distilled water intravenously.
干预措施: Distilled Water (Drug)
Group D
including 51 women who will receive a prefilled syringe with two milliliters (8 mg) of dexamethasone intravenously.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The interval between the initiation of induction and the delivery of the fetus.
时间窗: Up to 1 day
Mean time of interval between the initiation of induction and the delivery of the fetus in the two groups.
次要结局
- The duration of the third stage of labor.(Up to 30 minutes)
- The duration of the first stage of labor (Partographic representation will do for each participant).(Up to 1 hour)
- The neonatal outcome by APGAR score.(at 1 and 5 minutes)
- Any postpartum maternal adverse effects (e.g. vital sing abnormality, any maternal postpartum hemorrhage and central nervous system manifestation).(Up to 1 day)
- The duration of the second stage of labor.(Up to 2 hours)
研究者
samar sayed el sayed
Gynecologist and Obstetrician
Ain Shams University