Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section: Multicenter Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- Necessity of heterocatheterization within 24 hours following the cesarean section.
研究概览
简要总结
The hypothesis of this trial is that the absence of systematic bladder catheterization in patients performing spontaneous urination in the hour preceding the planned cesarean section under spinal anesthesia would not lead to more bladder heterocatheterization for postpartum urinary retention (RUPP) in the 24 hours post-cesarean section than systematic intraoperative bladder catheterization up to 2 hours post-surgery.
详细描述
Introduction:
The recommendations for the clinical practice of cesarean section, published by the National College of French Gynecologists and Obstetricians (CNGOF) in 2022, have led to a standardized surgical technique. During this surgery, urinary catheterization is use and allows to avoid urinary retention and give a better chirurgical exposition. But it presents also risks as urinary infection development or pain and discomfort for the patient. Actually, the CNGOF wonders if for women having a cesarean section, preoperative spontaneous urination would reduce urinary complications compared to the placement of an intraoperative bladder catheter. The current literature does not allow to respond satisfactorily to this question. This is why C2S study proposes a cesarean section without urinary catheterization following a spontaneous miction.
Aim:
The aim of this trial is to evaluate the rate of bladder heterocatheterization in cases of postpartum urinary retention (RUPP) within 24 hours following a planned cesarean section under spinal anesthesia, according to two management methods: the absence of intraoperative catheterization associated with spontaneous urination in the hour preceding the cesarean section versus systematic intraoperative bladder catheterization up to 2 hours postoperatively. Moreover, this trial will allows to evaluate benefits and risks of the urinary catheterization absence.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The care provider carrying out the heterocatheterization will be blinded to the participant's randomization group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patient
- •Patient admitted for a planned cesarean section after 34 weeks under spinal anesthesia
- •Single or twin pregnancy
- •Unscarred or with one or two scars of the uterus
排除标准
- •Positive urine test strip showing a presence of nitrites or leukocytes, the day before the surgery suggesting asymptomatic bacteriuria
- •Emergency Caesarean
- •Scheduled Caesarean section with intervention delayed beyond 3 p.m. for service organization reasons
- •Epidural anesthesia
- •Contraindication to spinal anesthesia (uncorrected hypovolemia; blood coagulation disorders; sepsis or severe inflammation at the puncture site; neurological deficit; migraine pattern; spinal cord disease; spinal malformation; febrile syndrome)
- •ASA (American Society of Anesthesiologists) score ≥ 4
- •Placental insertion abnormality (placenta previa and/or accreta)
- •Medical indication for monitoring of diuresis
- •Oliguria or renal failure
- •Indication for use of intrathecal clonidine during scheduled cesarean section
- •History of bladder surgery or surgical urological pathology during pregnancy (JJ catheter in place)
- •History of complex abdominal surgery
- •Impossibility or absence of obtaining free, informed and written consent, after a period of reflection
- •Patient not affiliated or beneficiary of a national health insurance system
- •Patient under legal protection, under guardianship or under curatorship
- •Patient having participated in interventional research on a drug within 3 months before inclusion
- •Patient participating in another interventional research
- •Patient in exclusion period determined by another study
研究组 & 干预措施
Arm A: Intraoperative bladder catheterization
Patients will have spontaneous urination in the hour preceding the caesarean section and will have a systematic intraoperative bladder catheterization.
干预措施: Spontaneous urination during the hour before caesarean section. (Procedure)
Arm A: Intraoperative bladder catheterization
Patients will have spontaneous urination in the hour preceding the caesarean section and will have a systematic intraoperative bladder catheterization.
干预措施: Systematic bladder catherization during caesarean section. (Procedure)
Arm B: Absence of intraoperative bladder catheterization
Patients will have spontaneous urination in the hour preceding the caesarean section but will not have intraoperative bladder catheterization.
干预措施: Spontaneous urination during the hour before caesarean section. (Procedure)
结局指标
主要结局
Necessity of heterocatheterization within 24 hours following the cesarean section.
时间窗: Between Hour 0 (time of surgical closure) and Hour 24
Heterocatheterization is indicated in cases of Complete postpartum urinary retention (RUPP-C) or in cases of Partial postpartum urinary retention (RUPP-P) with a post-void residue (measured by Bladder scan) greater than the volume urinated (measured in a graduated jar), provided the volume urinated exceeds 150 ml.
次要结局
- Experience of childbirth(Hour 24)
- Duration of preoperative preparation(Between entering the surgery room and incision during the surgical procedure)
- Operating time(During surgery (Between incision and surgical closure))
- Duration of post-operative hospitalization(Discharge from hospitalization (Maximum 1 month after the cesarean section))
- Time to resume ambulation(Discharge from hospitalization (Maximum 1 month after the cesarean section))
- First urination(Discharge from hospitalization (Maximum 1 month after the cesarean section))
- Pain during the first urination or the first heterocatheterization(Between Hours 6 and 9)
- Discomfort during the first urination or the first heterocatheterization(Between Hours 6 and 9)
- Additional prescription for painkillers(Discharge from hospitalization (Maximum 1 month after the cesarean section))
- Urinary infection detection(Hour 24)
- Occurrence of surgical difficulties(During caesarean section procedure)
- Occurrence of operative complications(Between surgical incision and discharge of hospitalization (Maximum 1 month after the cesarean section))
- Amount of bleeding(Between surgical incision and Hour 0, Hour 0 and Hour 3, Hour 3 and Hour 24.)
- Presence of symptoms suggestive of a urinary infection(Between Hour 24 and the postpartum consultation at 6 weeks +/- 2 weeks)
- Presence of functional signs (dysuria, incontinence, delayed bleeding or others)(Between Hour 24 and the postpartum consultation at 6 weeks +/- 2 weeks)
- Time before resuming spontaneous urination(Postpartum consultation at 6 weeks +/- 2 weeks.)