A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section: is the Management of Labor Improved?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 主要终点
- Detection of dystocia during labor in women with past history of cesarean section
研究概览
简要总结
The main objective is to evaluate a specific cervicograph (the graph describing the cervical dilation, included in the partograph) for pregnant women with an history of cesarean section, to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women will be randomly assigned to this specific cervicograph (including an action line 2 hours after the alert line), or to the normal cervicograph (no lines). The primary outcome is appropriate detection of dystocia.
详细描述
Appropriate management of labor is essential to minimize the risk of uterine rupture in case of attempt at vaginal delivery after a cesarean section (VBAC). Dystocia is a known risk factor for uterine rupture during labor in women with previous cesarean section. Some studies have shown that this risk increases after 2 hours at the same cervical dilation during labor. The cervicograph is an important tool to detect dystocia during labor. There is currently no specific cervicograph for pregnant women with a history of cesarean section, and no study evaluated the cervicograph in the monitoring of labor for women with a scarred uterus.
The main objective is to evaluate a specific cervicograph (the graph describing the cervical dilation, included in the partograph) for pregnant women with an history of cesarean section, to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women will be randomly assigned to a specific cervicograph (including an action line 2 hours after the alert line), or to the normal cervicograph (no lines).
The outcomes of this randomized trial are: appropriate detection and management of dystocia; uterine rupture; and success of VBAC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The cervicograph of all participants will be reviewed by two assessors blinded to the study group. In order to be blinded, lines will be added to the cervicographs of the control group by a third party not involved in the evaluation
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women in labor, admitted for a VBAC at a gestational age of 37 weeks or more
- •Single pregnancy
- •Cephalic presentation
排除标准
- •More than 1 previous cesarean section
- •Multiple pregnancies
- •Presentations other than cephalic
- •History of low vertical uterotomy, classical or inverted T-shaped
- •Past history of myomectomy
- •Fetal death
- •Fetal anomalies
- •Placental anomalies
研究组 & 干预措施
specific cervicograph
Specific cervicograph, including an alert line (normal progression of cervical dilation, i.e. 1 cm per hour) and an action line 2 hours after the alert line. This should be completed after the diagnose of active labor
干预措施: specific cervicograph (Diagnostic Test)
Usual cervicograph
The usual cervicograph in our unit is not having lines
结局指标
主要结局
Detection of dystocia during labor in women with past history of cesarean section
时间窗: From inclusion in the study (randomization usually from 2cm) until full cervical dilation.
Appropriate detection and management of dystocia by identifying women with: no progression of cervical dilation for more than 2 hours during labor; or slow progress, defined as a cervical dilation of less than 2 cm in 4 hours; and immediate decision of cesarean section, to be performed within 30 minutes.
次要结局
- Uterine rupture during labor in women with past history of cesarean section(From inclusion in the study (randomization usually from 2cm) until delivery)
研究者
Michel Boulvain
MD, PhD
University Hospital, Geneva