UACE Followed by Uterine Suction Curettage for the Treatment of Caesarean Scar Pregnancy
NCT02357095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2015-02-06
Summary
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.
Conditions
- Caesarean Scar Pregnancy
Interventions
- PROCEDURE
-
monitoring
uterine artery chemo-embolization combined with suction curettage under different monitoring methods,such as hysteroscopic monitoring,ultrasonography monitoring and no monitoring
Sponsors & Collaborators
-
Maternal and Child Health Hospital of Hubei Province
lead OTHER
Principal Investigators
-
Wu X-Feng, Ph.D & MD · Maternal and Child Health Hospital of Hubei Province,Wuhan,Hubei,PR China
-
Gao Han, Bachelor · Maternal and Child Health Hospital of Hubei Province,Wuhan,Hubei,PR China
-
Ma Quan-Fu, Ph.D & MD · Maternal and Child Health Hospital of Hubei Province,Wuhan,Hubei,PR China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2014-06-30
- Completion
- 2014-12-31
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