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临床试验/NCT02357095
NCT02357095已完成不适用

Evaluation of the Efficacy and Complications of UACE Combined With Suction Curettage Under Different Kind of Monitoring Methods for the Treatment of Caesarean Scar Pregnancy

Maternal and Child Health Hospital of Hubei Province0 个研究点目标入组 144 人开始时间: 2010年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
144
主要终点
Composite outcome measure:the effectiveness of UACE followed by suction curettage for the treatment of CSP

研究概览

简要总结

The purpose of this study is to determine whether UACE(uterine artery chemo-embolization) followed by suction curettage under the guidance of ultrasonography or hysteroscopy can decrease complications in the treatment of Caesarean scar pregnancy (CSP).

CSP is a special form of ectopic implantation within a fibrous tissue surrounding the previous delivery caesarean scar. The probability of CSP is 1:1800 to 1:2,226 in all pregnancies, and 6.1% in ectopic pregnancy after cesarean delivery. It's a long-term complication after cesarean delivery with very serious consequences,such as uterine rupture and massive uterine bleeding.There are more than ten methods to treat CSP,however, no universal management guidelines have been established up to now.

Present methods for CSP treatment include:1)medical treatment,usually systemic or local methotrexate(MTX);2)suction curettage;3)medicine combined with uterine curettage;3)surgical treatment(hysteroscopic,laparoscopic or vaginal surgery);4) uterine artery embolization(UAE);5) The combined use of the above methods.

Moreover, the rupture of the CSP and heavy bleeding may still occur following medical treatment.Suction curettage and excision of the CSP are associated with profuse bleeding. Surgical treatment is less micro-traumatic than nonsurgical interventions. For CSP, UAE followed by suction curettage appears to have more advantage than systemic MTX treatment and may be a priority option.So some author suggests that curettage and systemic methotrexate therapy and embolization as single treatments should be avoided if possible,combination of them is more effective. Plenty of evidences suggested that UACE followed by suction curettage under the guidance of ultrasonography or hysteroscopy is a priority choice.

However,in our clinical practices,suction curettage of CSP is more difficult than usual induced abortion procedure of normal early pregnancy,because PCSD(previous cesarean scar defect)is very common in CSP.In random populations the incidence of PCSD is present in 24%-69% of women evaluated with transvaginal sonography. Scar defects were seen in 61% (66/108), 81% (35/43) and 100% (11/11) of the women who had undergone one, two and at least three Cesarean sections by the transvaginal ultrasound examination.

What is the incidence of complications of suction curettage combined with UACE for CSP treatment remains unknown.How to decrease the complications remains unknown too.So we designed this study.

详细描述

At first,the investigators evaluated the sample size will be 108 at least through software PASS11, which actually was 144 finally.Then the CSP patients visited or transferred to Maternal and Child Health Hospital of Hubei Province(China) from June 2010 to June 2014 were recruited.Every patient was numbered in chronological sequence.Then participants were randomly assigned into three arms using a randomization table :Group A(Group hysteroscopic monitoring), Group B(Group ultrasonography monitoring),and Group C(Group no monitoring). Randomization was conducted via a system of sealed and numbered envelopes.

Everybody received UACE(uterine artery chemo-embolization) first. Superselective embolization of both uterine arteries was performed using gelatin sponge particles by two experienced radiologists. After the puncture of the right femoral artery, a 5-F Roberts uterine artery catheter was correctly placed in the bilateral uterine artery with the guidance of a 0.889-mm guidewire.A 50mg dose of MTX was infused bilaterally prior to the gelatin sponge particles selective embolism procedure. Postembolization angiography was performed to confirm that the occlusion of the vessels was complete. Within 24-48 h after UACE, women underwent suction curettage.The subatmospheric pressure was 200~500mmHg during suction curettage.

Women assigned to the Group A(Group hysteroscopic monitoring) received UACE followed by suction curettage under hysteroscopic monitoring.Before and after suction curettage, hysteroscopy was performed.If some residual tissues were found, suction curettage would be performed again to remove them.

Women assigned to the Group B(Group ultrasonography monitoring) received UACE followed by suction curettage under ultrasonography monitoring.The suction curettage procedure was performed under abdominal ultrasonography real- time monitoring.When there were nothing residual under ultrasonography,the procedure was completed.

Women assigned to the Group C(Group no monitoring) received UACE followed by suction curettage without monitoring.

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
None

入排标准

年龄范围
22 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •pre-operative diagnosed as CSP;hemodynamic stability

排除标准

  • •acute PID(pelvic inflammatory disease) or vaginitis;shock;prior classical cesarean section;prior treatment with suction curettage or MTX

研究组 & 干预措施

hysteroscopic monitoring

Experimental

Method used for the treatment of CSP:Uterine artery chemo-embolization followed by suction curettage under hysteroscopic monitoring.The brand of hysteroscope machine is STORZ.

干预措施: monitoring (Procedure)

ultrasonography monitoring

Experimental

Method used for the treatment of CSP:Uterine artery chemo-embolization followed by suction curettage under ultrasonography monitoring.The brand of ultrasonograph is mindray(Z6).

干预措施: monitoring (Procedure)

no monitoring

Experimental

Method used for the treatment of CSP:Uterine artery chemo-embolization followed by suction curettage under no monitoring

干预措施: monitoring (Procedure)

结局指标

主要结局

Composite outcome measure:the effectiveness of UACE followed by suction curettage for the treatment of CSP

时间窗: two months

Serum hCG are measured every week post-operation till it resolute to normal level.Operation time are recorded.The time of menstrual recovery are recorded.

The number of participants with complications in different Arms.

时间窗: two months

The complications of blood loss,incomplete abortion,intrauterine adhesions,induced abortion syndrome,uterine perforation,PID,and amnionic fluid embolism are recorded.The number of participants with complications in different Arms is counted.

次要结局

  • Composite outcome measure:Baseline clinical characteristic of patient when diagnosed with CSP(one week)

研究者

发起方
Maternal and Child Health Hospital of Hubei Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanli Li

Gynecologist

Maternal and Child Health Hospital of Hubei Province

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