Efficacy of Oral Mifepristone for Cervical Ripening and Induction of Labour on an out-patient basis in low risk pregnant women with past dates
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- 1. Rate of successful vaginal delivery
研究概览
简要总结
Induction of labour is indicated for various reasons (maternal and foetal). A successful vaginal delivery requires the presence of a favourable cervix and hence before any method of induction, cervical assessment is essential. Mifeprstone (RU 486) is a steroid that has antiprogesterone properties. The most commonly approved indications for use of Mifepristone in obstetrics are termination of early pregnancy, labour induction in case of foetal death in uterus. It causes softening and dilatation of the cervix and also results in an increase in uterine cavity. This effect, observed in various clinical studies reduced the doses of prostaglandins needed, and shortened the time necessary for expulsion of foetus in termination of pregnancies. Therefore, the aim of this study is to evaluate the efficacy of a single dose of mifepristone for cervical ripening and induction of labour at term.
Those women more than 40 weeks and planned for induction of labour who consent to the study will be given one dose of Oral Mifepristone (200mg) 48 hours prior to the date of induction of labour. NST will be taken and the patient will be sent home. They will be adviced to come back for routine induction after 48 hours or earlier if they have spontaneous pain, leaking PV or decreased foetal movements. A re- assessment per vaginal examination will be done after 48 hours or earlier if the onset of labour has taken place.
The primary outcome will be to calculate the rate of vaginal delivery and improvement in Bishop’s score after 48 hours or earlier if onset of labour has taken place.
The secondary outcomes will be to assess the need for augmentation with oxytocin, number of patients who needed misoprostol for induction, number of doses of misoprostol required, intrapartum complications such as hyperstimulation and other CTG abnormalities. Foetal complications such as APGAR score at 5 and 10 minutes, meconium aspiration, low cord pH and NICU admissions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women at term (>40 weeks and above) with singleton pregnancy in cephalic presentation.
排除标准
- •1.Previous LSCS 2.Hypertension, pre-eclampsia 3.IUGR, oligohydraminos 4.Diabetes on Insulin 5.Low lying placenta 6.Chorioamnionitis or rupture of membranes 7.Bishop score more than 6 at the time of enrolment 8.Non- reactive NST 9.Intra-uterine foetal death 10.Any contraindication for vaginal delivery (e.g., cephalo-pelvic disproportion).
结局指标
主要结局
1. Rate of successful vaginal delivery
时间窗: 1. Rate of successful vaginal delivery | 2. Improvement in Bishop’s score after 48 hours of induction or at the time of onset of labour
2. Improvement in Bishop’s score after 48 hours of induction or at the time of onset of labour
时间窗: 1. Rate of successful vaginal delivery | 2. Improvement in Bishop’s score after 48 hours of induction or at the time of onset of labour
次要结局
- a. Maternal(1.Need / Number of doses of Misoprostol required on admission)