A randomized control trial comparing efficacy and safety of controlled release dinoprostone vaginal insert and dinoprostone gel for labor induction
试验速览
- 阶段
- 不适用
- 状态
- Not Applicable
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Primary outcome - Induction to vaginal delivery interval - Need for oxytocin to augment labour occurrence of hyper stimulation, non-reassuring CTG - Mode of delivery - APGAR score, cord pH & NICU admissions - Maternal morbidity during labour Sample size is calculated from previous 6 years data
研究概览
简要总结
Project aims Situations arise in obstetrics it becomes necessary to interrupt pregnancy in the interest of the mother and the fetus. Our main objective would be to evaluate the efficacy, safety of sustained release vaginal pessary, compared to dinoprostone gel.
Materials and Methods It is a randomized controlled trial comparing dinoprostone vaginal gel and controlled release pessary for induction of labour at Sultan Qaboos University Hospital over 2 years. All eligible, term patients for induction of labour will be recruited. Randomisation sequence will be done using a computer-generated random number and block randomisations. The on call doctor, will allocate and insert the drugs in 1:1 ratio.
Primary outcomes will be induction to delivery interval, number of successful vaginal deliveries and any complications. Secondary outcome measure is to perform the cost effective analysis and patients satisfaction during labour induction process. We will follow the CONSORT 2010 guideline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 15.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Singleton pregnancy Term pregnancy of 37 weeks or more Cephalic presentation Bishop score 6 or less, Intact or ruptured membranes.
- •The following women will be excluded.
排除标准
- •Previous scared uterus (cesarean section, extensive myomectomy involving the uterine cavity, previous uterine rupture or dehiscence), Para 4 or more, multiple pregnancy, estimated fetal weight more than 4 kilograms, abnormal CTG (cardiotocogram).
- •Any contraindication for vaginal delivery (placenta previa, malpresentation, active genital herpes infection).
- •Women with contraindication or hypersensitive to dinoprostone.
结局指标
主要结局
Primary outcome - Induction to vaginal delivery interval - Need for oxytocin to augment labour occurrence of hyper stimulation, non-reassuring CTG - Mode of delivery - APGAR score, cord pH & NICU admissions - Maternal morbidity during labour Sample size is calculated from previous 6 years data
时间窗: End point for cervical ripening are strong uterine contractions , bishop score 6. Induction of labour will be considered successful if vaginal delivery within 24 hours of induction.
次要结局
- Patient satisfaction (a scale of 100) after delivery. - Cost effective analysis of the two induction methods - Subgroup analysis based on the Bishop score and parity.