Effect Of Intra-muscular Administration of Dexamethasone on the Duration of Induction of Labour in Primigravida Post-term Pregnancy.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- the duration between induction and beginning of active phase.
研究概览
简要总结
ABSTRACT:
Objective: To evaluate the efficacy of dexamethasone on labor duration and to establish whether dexamethasone plays a role in shorting the duration interval between initiation of labor induction and beginning of the active phase in primigravida full-term pregnancy.
Methods: case control study included 86 primigravidae with full term pregnancy classified into two groups: The participant of Group I will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular, and the participants of Group II will not receive Dexamethasone or any other cervical ripening agent.
Key Words: Dexamethasone;post-term pregnancy;induction of labor.
详细描述
METHODS:
This retrospective clinical trial was conducted at the Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, during the period from August 2014 to May 2015. The study protocol was approved by the Scientific Research Committee, and informed consent was obtained from all participants.
Each participant will randomly be assigned by computer list into Group I (Dexamethasone group(n=43)and group II(control group(N=43).
No cervical ripening agent will be used for induction of labour in the trial.
Methodology in details:
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy.
- •Primigravida.
- •Post-term gestation i.e. 41 weeks or more.
- •Sure, reliable dates.
- •Favorable cervix with Bishop score of 7 or greater.
- •Longitudinal lie.
- •Cephalic presentation (Vertex).
排除标准
- •Abnormal presentation.
- •Multigravida.
- •Multiple pregnancies.
- •Active phase of labour.
- •Cephalo-pelvic disproportion.
- •History of any medical disorder.
- •History of previous myomectomy operation.
- •Known contraindication or hypersensitivity to Dexamethasone.
- •Current fetal distress.
- •Current maternal or fetal disorder e.g. Diabetes mellitus; Pregnancy induced hypertension, and fetal growth retardation.
- •Over distended abdomen e.g. fetal macrosomia or polyhydramnios suggested by ultrasound or estimated fetal weight by expert hand.
- •Significant vaginal bleeding.
研究组 & 干预措施
dexamethasone group
The participant of Dexamethasone Group will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular After six hours of the initial dose, the labour induction will start via Oxytocin .III. The interval between the initiation of induction and the beginning of the active phase of labour is recorded (a cervical dilatation of 4 cm plus 3 forceful contractions over a 10-minute span each last from 40-60 Sec).
干预措施: Dexamethasone (Drug)
Placebo group
and the participants of placebo Group will not receive Dexamethasone or any other cervical ripening agent.II.two milliliters of normal saline given.
干预措施: Placebo (Drug)
结局指标
主要结局
the duration between induction and beginning of active phase.
时间窗: 6 months
次要结局
- Duration of first stage.(7 months)
研究者
Mohamed El-Sharkawy
Lecturer of obstetrics and gynecology
Kasr El Aini Hospital