UACE Followed by Uterine Suction Curettage for the Treatment of Caesarean Scar Pregnancy
Condition: Caesarean Scar Pregnancy
MeSH terms: Cicatrix
Study type: Interventional

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.
    

Detailed description: 
      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.

      All patients were observed during the hospitalization. Ages, weight,gravidity,parity,weeks of
      gestation, clinical manifestation of CSP,estimated blood loss, operation time,length of
      uterine cavity and PCSD(previous cesarean scar defect), and side effects(such as fever,
      nausea,and low abdominal pain) were recorded. The serum β-hCG level and renal, hepatic
      function, and complete blood count were measured before intervention. The size of the
      gestation sac or a heterogeneous mass was measured by transvaginal ultrasound at the same
      time.

      The patients were followed up by measuring serum β-hCG level every week until the β-hCG level
      reverted to normal.All women were followed up 2 weeks and 2 months after operation, which
      included ultrasound examination, and clinical assessment (bleeding pattern and resumption of
      menses).

      Theχ2 test were used for the analysis of enumeration data. The measurement data comparisons
      between groups were tested by ANOVA analysis. A probability value of<.05 was considered
      statistically significant.All data analyses were conducted with SPSS software
      (version17.0;SPSS,Inc,IBM,American).
    

Intervention name(s): monitoring
Intervention type(s): Procedure
Intervention description(s): uterine artery chemo-embolization combined with suction curettage under different monitoring methods,such as hysteroscopic monitoring,ultrasonography monitoring and no monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Caesarean Scar Pregnancy; uterine artery chemo-embolization; treatment