CTRI/2024/05/067880尚未招募Post Marketing Surveillance
Comparative study of efficacy of dinoprostone gel alone and mifepristone with dinoprostone gel as cervical ripening agent
DR M Rasheed1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月25日最近更新:
试验速览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.Bishop score after 6 hrs of 1st dose of diniprostone gel
研究概览
简要总结
- The process by which the cervix becomes soft, compliant and partially dilated is termed “cervical ripening.†Cervical ripening is thought to be due to combination of biochemical, endocrinal , mechanical, and possibly inflammatory events. Cervical ripening allows the uterine contractions to effectively dilate the cervix.The goal of cervical ripening is to facilitate the process of cervical softening, effacement and dilatation, thus reducing the induction-to-delivery time. When there is an indication for induction and the cervix is unfavorable, agents for cervical ripening may be used.The two major techniques for iatrogenic cervical ripening are.Mechanical interventions, such as insertion of catheters or cervical dilators and Pharmacological such as application of cervical ripening agents (prostaglandins).Successful labour induction is related to state of the cervix. Pregnant lady with unfavorable cervix, who have not experienced cervical ripening phase prior to labour, present a great challenge with regard to induction of labour. So, Bishop’s scoring is done to see whether the cervix is favorable or not. If induction is done in an unfavorable cervix, chances of prolonged labour and chances of having cesarean section will be increased. To reduce cesarean section rate cervical ripening is done prior to induction. Local application of prostaglandin E2 – dinoprostone – is commonly used for cervical ripening.Mechanical interventions, such as insertion of catheters or cervical dilators and Pharmacological such as application of cervical ripening agents (prostaglandins).Successful labour induction is related to state of the cervix. Pregnant lady with unfavorable cervix, who have not experienced cervical ripening phase prior to labour, present a great challenge with regard to induction of labour. So, Bishop’s scoring is done to see whether the cervix is favorable or not. If induction is done in an unfavorable cervix, chances of prolonged labour and chances of having cesarean section will be increased. To reduce cesarean section rate cervical ripening is done prior to induction. Local application of prostaglandin E2 – dinoprostone – is commonly used for cervical ripening.Mifepristone/RU-486, a new class of pharmacological agent (antiprogesterone), has been developed to antagonize the action of progesterone. It is the 19 nor-steroid, which has greater affinity for progesterone receptor than does progesterone itself. It blocks the action of progesterone at the cellular level.Mifepristone also is a steroidal compound that has antiglucocorticoid and antiprogesterone properties. Progesterone stops uterine contractions, so mifepristone is used to stop the action of this hormone; thus, it induces labor or allows the pregnancy to be terminated. Mifepristone is a potential method of inducing labor in late pregnancy through its action in antagonizing progesterone, thus increasing uterine contractility and increasing the sensitivity of uterus to the action of prostaglandins.After meeting the eligibility criteria, all patients will be randomly allocated to two groups after written & informed consent.Group A (n=100) cervical ripening with dinoprostone gel.Group B ( n= 100) with mifepristone 200 mg followed 48 hrs by dinoprostone gel.Maximum of 3 doses of 0.5mg dinoprostone gel with an interval of 6 hrs.
- Primary outcome : Bishop score after 6 hrs of 1st dose of diniprostone gel , Induction to delivery time, mode of delivery.
- Secondary outcome : APGAR score of neonate at birth & after 5min, PPH, hospital stay.
研究设计
- 研究类型
- Pms
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Term singleton pregnancy in Cephalic Presentation with intact membrane with Bishop score less than 5.
排除标准
- •Any presentation other than cephalic, pregnancy with asthma, any contraindication to prostaglandins, previous uterine scars, multiple pregnancy.
结局指标
主要结局
1.Bishop score after 6 hrs of 1st dose of diniprostone gel
时间窗: 12 months
2.Induction to delivery time
时间窗: 12 months
3.mode of delivery
时间窗: 12 months
次要结局
- 1. APGAR score of neonate at birth & after 5min(2.PPH)
研究者
Dr Charu Jain
Command Hospital Air Force, Bengalore
研究点 (1)
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