Surgery Alone Versus Methotrexate Before Surgery in Cases of First Trimester Cesarean Scar Pregnancy: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Estimated blood loss intraoperative
研究概览
简要总结
There are no universal treatment guidelines available. The ultimate purpose of the management of CSP is to simultaneously remove the pregnancy and successfully preserve the woman's fertility (Gonzalez & Tulandi, 2017). A variety of medical and surgical treatment modalities for CSP have been reported; however, most of these are based on low-level evidence(Sun et al., 2019).
详细描述
This will be a randomized clinical trial to evaluate the effect of administration of methotrexate before surgery in reducing bleeding, injury to bladder and ureter, operative time and removing of CSP mass.This will be in comparison to surgery alone in cases of first trimester cesarean scar pregnancy
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 (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age before 13 w
- •Past history of 1 or more CS
- •Presence of GS implanted on cesareans scar
排除标准
- •Presence of severe vaginal bleeding (emergency)
- •Previous history of uterine surgery other than CS
- •The whole mass is interior and the bulge is more in the cavity
- •Bleeding disorder
- •Patient not candidate for methotrexate (Positive fetal heart pulsation,
- •Patient refuse to participate in the study
研究组 & 干预措施
surgery
- Valid consent
- Anathesia , (regional may br converted into general ). IV antibiotic ( cefotaxime 1 gm I.V )
- Laparotomy transverse incision (pfannenstiel incision)
- Exploration of the abdominal cavity
- Identification of the uterus, dissection of the bladder, incision of the uterus and excision of the CSP mass.
- Surgical repair of the uterine incision, and the abdomen
干预措施: Methotrexate (Drug)
methotrexate before surgery
Valid consent
- patient will receive 50 mgm /m2 of methtrexate after full investigation ( CBC, serum creatinie, AlT, AST), 1 week before surgery.
- Anathesia , (regional may br converted into general ). IV antibiotic ( cefotaxime 1 gm I.V )
- Laparotomy transverse incision (pfannenstiel incision)
- Exploration of the abdominal cavity
- Identification of the uterus, dissection of the bladder, incision of the uterus and excision of the CSP mass.
- Surgical repair of the uterine incision, and the abdomen
干预措施: Methotrexate (Drug)
结局指标
主要结局
Estimated blood loss intraoperative
时间窗: intraoperative blood loss
the amount of blood in soaked towels and vacuum aspiration
次要结局
- need further management(1 month)
- • Rate of urological injury(immediatly and 1 week post operative)
- • Rate of readmission, relaparotomy(with in 1 month)
研究者
Maher elesawi kamel elesawi
Lecturer of obstetric and gynecology
Mansoura University