The Cervical Sliding Sign as a Marker in Prediction of Successful Induction of Labor
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Mode of delivery
研究概览
简要总结
Assess the role of transvaginal ultrasound specifically a sign called cervical sliding sign, in the prediction of success of induction of labor.
The prediction of outcome of induction of labor has always been an important topic to all obstetricians. Bishop score is traditionally considered reliable way to predict the outcome of induction of labor by assessing the cervical dilatation, effacement, position, and consistence and assessing the level of the fetal head in the birth canal. Since The bishop score remains a highly subjective method for prediction of outcome of induction of labor, the use of sonographic measurements such as cervical sliding sign can be a better predictor of successful induction of labor.The presence of CSS was defined as the sliding of the anterior cervical lip on the posterior one under gentle pressure of the transvaginal probe.
Patients undergoing induction of labor with misoprostol will be checked for the cervical sliding sign. The mode of delivery, induction to active labor time and active labor to delivery time will be recorded and analysed to assess whether the sliding sign is an independent predictor of success of induction.
详细描述
Induction of labor is a common practice in modern obstetrics. It is the use of mechanical or pharmacological -or both ways- to stimulate uterine contractions before spontaneous labor to induce cervical dilatation and delivery. Induction of labor at term have many advantages. It can reduce to risk of still birth. It also reduces the risk of macrosomia and its adverse outcomes such as maternal trauma, shoulder dystocia or the need for instrumental delivery (Kim, et al., 2019). However, induction of labor can also have adverse outcomes, the most common is failure and increasing the risk of cesarean section. Induction of labor may not be tolerated by some patients because of the potential increase in the duration of labor or a prolonged latent phase. Increased cost compared to spontaneous delivery course and possible neonatal morbidity if the gestational age is less than 39 weeks of gestation are other drawbacks. (Kim, et al., 2019) Since the success of induction of labor is related to the condition of the cervix, investigators have proposed the importance of having a reliable system for determining the cervical maturity. A number of studies considered the use of sonographic measurement of cervical length to predict the success of labor induction. The sonographic marker for assessing the cervical softening called the cervical sliding sign (CSS) which was introduced by (Volpe, et al., 2019), demonstrated its correlation with the occurrence of impending delivery in women with preterm uterine contractions. The performance of the CSS in predicting the success of IOL was conducted in two academic centers by (Volpe, et al., 2022). However, its generalizability to community hospitals cannot be certain and needs further testing. The presence of CSS was defined as the sliding of the anterior cervical lip on the posterior one under gentle pressure of the transvaginal probe. (Volpe, et al., 2022)
Aim/ Objectives. Assess the role of the cervical sliding sign (CSS) as a marker in the prediction of the outcome of induction of labor (IOL) at term gestation.
Research Hypothesis:
The presence of Cervical Sliding sign in pregnant women at term gestation planned for Induction of labor predicts a higher chance of vaginal delivery within 24 hours.
Research Question:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women age: from 18 to 45 years old.
- •Single living term fetus with gestational age ≥ 37 weeks.
- •3- Eligible for IOL. 4- Bishop score <6 5- Estimated fetal weight < 4Kg.
排除标准
- •1- previous caesarean section. (increases risk of rupture uterus) 2- Multiple pregnancy, IUFD, preterm or macrosomic fetus (defined as fetus
- •>4.5kg or fetus of diabetic mother >4Kg) (increases risk of shoulder dystocia) 3- Women with major uterine anomalies. (appendix A: ESHRE/ESGE classification for Female genital tract anomalies (Grimbizis GF, et al,. 2013) (increases risk of CS) 4- Vasa previa, placenta previa (increases risk of antepartum hemorrhage) 5- previous myomectomy reaching the endometrial cavity. (Increases risk of rupture uterus) 7- patient refuse to participate or inability to consent. (patient's right to refuse).
研究组 & 干预措施
term pregnant women with Singleton living fetus attending for induction of labor
干预措施: Transvaginal ultrasound (Device)
term pregnant women with Singleton living fetus attending for induction of labor
干预措施: Misoprostol 200mcg Tab (Drug)
结局指标
主要结局
Mode of delivery
时间窗: 48 hours
Vaginal or cesarean section
Induction to active labor time
时间窗: 48 hours
Start of induction till cervical dilation of 6 cm
Active labor to delivery time
时间窗: 10 hours
From cervical dilation of 6 cm till delivery of fetus
次要结局
未报告次要终点
研究者
Omaima Abbas Mahmoud
Resident
Ain Shams Maternity Hospital