French Ambulatory and Misgav Ladach Cesarean Section Techniques : a Results of a Comparative Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- delay to hospital discharge
研究概览
简要总结
In the last decades cesarean section rates are getting higher in many countries. The rise in those rates encourages obstetricians to improve operative techniques for a better maternal and fetal outcome.
Despite its worldwide spread, a general consensus on the most appropriate technique to use has not yet been reached.
The most known surgical technique is the MLC . A modified extraperitoneal method of caesarean section :" French Ambulatory Cesarean Section ( FAUCS) was described in the middle of the 90's by "Denis Fauck" and "Jacques Henri Ravina " However, no study comparing these two cesarean techniques was conducted. From where the investigators initiate this study .
详细描述
Caesarean Section (CS) is one of the most commonly performed operations worldwide The rate of CS continues to rise, despite initiatives to counter this trend. Cesarean sections have a higher morbidity rate than vaginal deliveries, with a substantial care and cost measurable by the mean hospital stay, the use of analgesics, and the potential for complications . Crucially, the birth of a new baby is an unique incentive to return quickly to "normal" function. Improving the cesarean section techniques is therefore of considerable importance in modern obstetrics.
One of the most widely used cesarean section techniques is the MLC method developed by Michael Stark et al. This approach is indicated as the optimal technique in view of its characteristic of reducing lower pelvic discomfort and pain, thus improving quality of life However, this intraperitoneal C-section interfere at least with future fertility desire.
The French Ambulatory Cesarean Section (FAUCS) technique has been employed by 10 practitioners in France for approximately 20 years. In a retrospective study over 3000 cases this innovative approach seems to provide a shorter recovery time with a Hospital discharge the day after surgery . Investigators introduced this technique in "Mongi Slim" university hospital in January 2018. In this study, investigators compare the FAUCS and the MLC techniques in termes of mother and child outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •gestational age of at least 37 weeks of amenorrhea
- •indication of elective cesarean delivery mode (breech presentation ; Fetal macrosomia ; Placenta previa)
排除标准
- •Fetal pathology diagnosed prenatally( intrauterine growth restriction , malformation, genetic pathology ... )
- •Morbidity adherent placenta
- •emergency Cesarean section
结局指标
主要结局
delay to hospital discharge
时间窗: up to 72 hours
report of total days spent in hospital after surgery
changes in post operative pain
时间窗: 6 hours ; 12 hours , 18 hours , 24 hours
changes in postoperative analgesic requirements, changes in self reported pain using the Visual Analog Scale for Pain (VAS Pain) intensity ( The pain VAS is a single-item scale.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\] )
次要结局
- operation time(during the surgery)
- neonatal acid base balance(immediately after fetal extraction)
- rate of short term incidents(during the surgery and 24 hours after surgery)
- patient autonomy questionnaire(up to 48 hours after surgery)
- blood loss(the day before surgery and the day after surgery (24 hours))
- newborn overall condition(5 minutes from birth)
研究者
Kaouther Dimassi
Associate professor
University Tunis El Manar