Routine Cervical Dilatation at the Non-labor Caesarean Section and Its Influence on Postoperative Pain: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- mean change of postoperative pain over time points mentioned in the time frame
研究概览
简要总结
Caesarean section is a common method of delivery in obstetrics. With the recent increase in the rate of this procedure, it is wise to understand and implement the optimal surgical technique. Therefore, different operational methods have been defined to reduce the risk of peri/post-operative morbidity.
The digital dilatation of cervix during elective caesarean section has still been a concern when evaluating this issue. This procedure is supposed to help the drainage of blood and lochia postpartum, thus reducing infection or the risk of postpartum haemorrhage (PPH). However, on the contrary, this mechanical manipulation may also result in contamination by a vaginal micro-organism and increase the risk of infections or cervical trauma. Additionally, the effect of routine cervical dilatation on patients' perception of pain has not been studied sufficiently yet. As a result, the current literature lacks evidence of cervical dilatation on postoperative pain and is even not all in agreement regarding the potential benefits on overall maternal morbidity.
详细描述
Caesarean section is a common method of delivery in obstetrics. With the recent increase in the rate of this procedure, it is wise to understand and implement the optimal surgical technique. Therefore, different operational methods have been defined to reduce the risk of peri/post-operative morbidity.
The digital dilatation of cervix during elective caesarean section has still been a concern when evaluating this issue. This procedure is supposed to help the drainage of blood and lochia postpartum, thus reducing infection or the risk of postpartum haemorrhage (PPH). However, on the contrary, this mechanical manipulation may also result in contamination by a vaginal micro-organism and increase the risk of infections or cervical trauma. Additionally, the effect of routine cervical dilatation on patients' perception of pain has not been studied sufficiently yet. As a result, the current literature lacks evidence of cervical dilatation on postoperative pain and is even not all in agreement regarding the potential benefits on overall maternal morbidity.
In this prospective study, our primary aim is to evaluate the effect of intra-operative digital dilatation of cervix on post-operative pain. We hypothesize that dilatation of the cervix as compared with non-dilatation will result in less pain by reducing fluid and blood stasis inside the uterine cavity. Our secondary objective is to assess the maternal morbidity including a reduction in haemoglobin concentrations, puerperal fever, puerperal endometritis and wound infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The women will be blinded to the intervention, but the investigator will not be blinded to the procedure allocation (due to the nature of the intervention).
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18-40
- •Gestational age: ≥ 37 weeks gestation with a BMI > 25 kg/m².
- •Singleton pregnancy.
- •Free medical history.
- •Nulliparous women who would undergo their first elective cesarean section at term without any labor pain or multiparous women who had undergone cesarean section in all the previous pregnancies without any labor pain.)
排除标准
- •the onset of labor with dilation of the cervix or women who felt labor pain before their previous cesarean operations.
- •Prolonged premature rupture of membranes.
- •Fever on admission or ongoing infection as Chorioamnionitis.
- •Current antibiotic therapy.
- •The need for Blood transfusion during or after CS.
- •Emergency CS and preterm cesarean section.
- •Pre-existing maternal disease as prepregnancy diabetes mellitus.
- •Women at term who had risk factors for postpartum haemorrhage, e.g. placenta previa
- •Women with Chronic pelvic pain
结局指标
主要结局
mean change of postoperative pain over time points mentioned in the time frame
时间窗: 8th, 24th, and 48th hours ,4th and 7th day after the operation
will be assessed using Numerical Rating Scale which is a segmented numeric version of the visual analog scale (VAS) in which the patient selects a whole number (0-10 integers) that best reflects the intensity of her pain.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").the numeric rating scale will be either administered verbally (therefore also by telephone) or graphically for self-completion.Scores range from 0-10 points, with higher scores indicating greater pain intensity.
次要结局
- Puerperal Endometritis(48 hours after operation)
- puerperal fever(1st and 2nd day postoperative)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University