Short and Intermediate Term Outcomes of Uterine Conservation After Cesarian Section in Cases of Placenta Accreta Spectrum
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- abnormal uterine bleeding
研究概览
简要总结
study will be carried out on patients with placenta accreta spectrum having done uterine conservation and recording immediate outcome of conservation regarding success of the procedure, amount of blood loss and amount of blood transfused and followed up to check the return of menses, any uterine abnormalities by ultrasound or hysteroscopy especially isthmocele and intrauterine synechia.
详细描述
After institutional review board approval and written informed consent, recruited cases will be subjected to the following:
- Data registration including:
- Age.
- Obstetric history including gravidity, parity, number of previous cesarean deliveries, and number and gender of living children.
- Details of the current pregnancy including duration in menstrual weeks, any problems encountered during its course.
- Desire for future fertility.
- Medical, surgical, and medication history.
- Anthropometry including weight, height, and body mass index (BMI) before pregnancy and at the time of operation.
- General examination including vital signs, and signs of any associated problems.
- Routine laboratory investigations with particular emphasis on complete blood count, Coagulation profile and including blood glucose level, renal and liver function tests.
- Detailed sonographic examination to evaluate fetal biometry, and wellbeing rule out exclusion factors, and confirm diagnosis of PAS and assess the degree of invasion, and its severity using both trans-abdominal transducer with frequency of 2-5 megahertz (MHZ) and trans-vaginal transducer with frequency of 4-10 MHZ.
Intraoperative details will be documented. Follow up of patients will be recorded. Sample size was calculated by estimating a single proportion distribution at a significance level of 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Diagnosed sonographically to have placenta accreta spectrum.
- •Pregnancy is singleton and fetus is alive.
- •Elective caesarean section done from 35 gestational weeks.
排除标准
- •• Patients requesting hysterectomy.
- •Coexisting uterine pathology such as fibroids or gynaecological malignancies.
- •Patients with bleeding diathesis.
- •Morbid obesity of BMI >
- •Patients having labour pains or vaginal bleeding before scheduled intervention.
结局指标
主要结局
abnormal uterine bleeding
时间窗: from 2 to 6 months after surgery
record the presence of abnormal uterine bleeding after the return of menses such as intermenstrual bleeding, menorrhagia
isthmocele
时间窗: from 3 to 6 months after surgery
trans-vaginal and trans-abdominal ultrasound will be done to record the presence of isthmocele, its shape and ratio between residual myometrium and total myometrium
date of resumed menses
时间窗: from 2 weeks to 6 months after surgery
calculate the duration from surgery until menses returns
puerperal blood loss
时间窗: 48 hours until 2 months after surgery
recording the duration of blood loss during puerperium and average number of tampons changed per day
menstrual abnormalities
时间窗: from 2 to 6 months after surgery
record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea
pelvic pain
时间窗: from 2 to 6 months after surgery
record the presence of pelvic pain and its duration
intrauterine adhesions
时间窗: from 3 to 6 months after surgery
outpatient hysteroscopy will be done to symptomatic patients after consent in order to check uterine cavity recording the presence of intrauterine adhesions, and categorization of adhesions according to american fertility society into mild, moderate and severe
contraception use
时间窗: intraoperative until 5 months after surgery
recording method of contraception used
fibrosis
时间窗: from 3 to 6 months after surgery
grey scale ultrasound will be done to record size of intra-myometrium fibrosis
次要结局
- packed red blood cells transfusion(intraoperative until 24 hours after surgery)
- fresh frozen plasma (FFP) transfusion(intraoperative until 24 hours postoperative)
- post-operative hemoglobin(postoperative within 6 hours from surgery)
- ureter injury(intraoperative until 2 weeks post operative)
- surgical site infection(24 hours until 1 month after surgery)
- hospital stay(postoperative until 10 days after surgery)
- ICU admission(immediate postoperative until 5 days after surgery)
- pre-operative hemoglobin(preoperative)
- intermediate care admission(recording the number of patients admitted to the ICU)
- operation time(intraoperative)
- repair time(intraoperative)
- bowel injury(intraoperative until 2 weeks post operative)
- Estimated blood loss(intraoperative)
- bladder injury(intraoperative until 2 weeks post operative)
- urine output(intraoperative)
- internal iliac artery ligation(intraoperative)
- surgical diagnosis(intraoperative)