search
Back to results

UACE Followed by Uterine Suction Curettage for the Treatment of Caesarean Scar Pregnancy (UACECSP)

Primary Purpose

Caesarean Scar Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
monitoring
Sponsored by
Maternal and Child Health Hospital of Hubei Province
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caesarean Scar Pregnancy focused on measuring Caesarean Scar Pregnancy, uterine artery chemo-embolization, treatment

Eligibility Criteria

22 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • pre-operative diagnosed as CSP;hemodynamic stability

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    hysteroscopic monitoring

    ultrasonography monitoring

    no monitoring

    Arm Description

    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.

    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).

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

    Outcomes

    Primary Outcome Measures

    The number of participants with complications in different Arms.
    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.
    Composite outcome measure:the effectiveness of UACE followed by suction curettage for the treatment of CSP
    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.

    Secondary Outcome Measures

    Composite outcome measure:Baseline clinical characteristic of patient when diagnosed with CSP
    Age,body weight,gravity and parity,previous caesarean section times,interval from last caesarean section,gestation age and symptoms when diagnosed,pre-treatment human chorionic gonadotropin(hCG) level and size of gestational sac are collected to investigate the relation between these index and CSP

    Full Information

    First Posted
    December 29, 2014
    Last Updated
    February 2, 2015
    Sponsor
    Maternal and Child Health Hospital of Hubei Province
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02357095
    Brief Title
    UACE Followed by Uterine Suction Curettage for the Treatment of Caesarean Scar Pregnancy
    Acronym
    UACECSP
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maternal and Child Health Hospital of Hubei Province

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caesarean Scar Pregnancy
    Keywords
    Caesarean Scar Pregnancy, uterine artery chemo-embolization, treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    144 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    hysteroscopic monitoring
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    ultrasonography monitoring
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    no monitoring
    Arm Type
    Experimental
    Arm Description
    Method used for the treatment of CSP:Uterine artery chemo-embolization followed by suction curettage under no monitoring
    Intervention Type
    Procedure
    Intervention Name(s)
    monitoring
    Intervention Description
    uterine artery chemo-embolization combined with suction curettage under different monitoring methods,such as hysteroscopic monitoring,ultrasonography monitoring and no monitoring
    Primary Outcome Measure Information:
    Title
    The number of participants with complications in different Arms.
    Description
    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.
    Time Frame
    two months
    Title
    Composite outcome measure:the effectiveness of UACE followed by suction curettage for the treatment of CSP
    Description
    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.
    Time Frame
    two months
    Secondary Outcome Measure Information:
    Title
    Composite outcome measure:Baseline clinical characteristic of patient when diagnosed with CSP
    Description
    Age,body weight,gravity and parity,previous caesarean section times,interval from last caesarean section,gestation age and symptoms when diagnosed,pre-treatment human chorionic gonadotropin(hCG) level and size of gestational sac are collected to investigate the relation between these index and CSP
    Time Frame
    one week

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: pre-operative diagnosed as CSP;hemodynamic stability Exclusion Criteria: acute PID(pelvic inflammatory disease) or vaginitis;shock;prior classical cesarean section;prior treatment with suction curettage or MTX
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wu X-Feng, Ph.D & MD
    Organizational Affiliation
    Maternal and Child Health Hospital of Hubei Province,Wuhan,Hubei,PR China
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Gao Han, Bachelor
    Organizational Affiliation
    Maternal and Child Health Hospital of Hubei Province,Wuhan,Hubei,PR China
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ma Quan-Fu, Ph.D & MD
    Organizational Affiliation
    Maternal and Child Health Hospital of Hubei Province,Wuhan,Hubei,PR China
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12666214
    Citation
    Jurkovic D, Hillaby K, Woelfer B, Lawrence A, Salim R, Elson CJ. First-trimester diagnosis and management of pregnancies implanted into the lower uterine segment Cesarean section scar. Ultrasound Obstet Gynecol. 2003 Mar;21(3):220-7. doi: 10.1002/uog.56.
    Results Reference
    result
    PubMed Identifier
    21838169
    Citation
    Stevens EE, Ogburn P. Cesarean scar ectopic pregnancy: a case report of failed combination local and systemic methotrexate management requiring surgical intervention. J Reprod Med. 2011 Jul-Aug;56(7-8):356-8.
    Results Reference
    result
    PubMed Identifier
    15924549
    Citation
    Wang CJ, Yuen LT, Chao AS, Lee CL, Yen CF, Soong YK. Caesarean scar pregnancy successfully treated by operative hysteroscopy and suction curettage. BJOG. 2005 Jun;112(6):839-40. doi: 10.1111/j.1471-0528.2005.00532.x. No abstract available.
    Results Reference
    result
    PubMed Identifier
    19527897
    Citation
    Zhuang Y, Huang L. Uterine artery embolization compared with methotrexate for the management of pregnancy implanted within a cesarean scar. Am J Obstet Gynecol. 2009 Aug;201(2):152.e1-3. doi: 10.1016/j.ajog.2009.04.038. Epub 2009 Jun 13.
    Results Reference
    result
    PubMed Identifier
    22516620
    Citation
    Timor-Tritsch IE, Monteagudo A. Unforeseen consequences of the increasing rate of cesarean deliveries: early placenta accreta and cesarean scar pregnancy. A review. Am J Obstet Gynecol. 2012 Jul;207(1):14-29. doi: 10.1016/j.ajog.2012.03.007. Epub 2012 Mar 10. Erratum In: Am J Obstet Gynecol. 2014 Apr;210(4):371-4.
    Results Reference
    result
    PubMed Identifier
    19087704
    Citation
    Zhuang YL, Wei LH, Wang W, Huang LL. [Treatment of pregnancy in a previous caesarean section scar with uterine artery embolization: analysis of 60 cases]. Zhonghua Yi Xue Za Zhi. 2008 Aug 26;88(33):2372-4. Chinese.
    Results Reference
    result
    PubMed Identifier
    23718134
    Citation
    Lan W, Hu D, Li Z, Wang L, Yang W, Hu S. Bilateral uterine artery chemoembolization combined with dilation and curettage for treatment of cesarean scar pregnancy: A method for preserving the uterus. J Obstet Gynaecol Res. 2013 Jun;39(6):1153-8. doi: 10.1111/jog.12051. Epub 2013 May 30.
    Results Reference
    result
    PubMed Identifier
    23206476
    Citation
    Zhang XB, Zhong YC, Chi JC, Shen JL, Qiu XX, Xu JR, Zhao AM, Di W. Caesarean scar pregnancy: treatment with bilateral uterine artery chemoembolization combined with dilation and curettage. J Int Med Res. 2012;40(5):1919-30. doi: 10.1177/030006051204000533.
    Results Reference
    result
    PubMed Identifier
    24373589
    Citation
    van der Voet LF, Vervoort AJ, Veersema S, BijdeVaate AJ, Brolmann HA, Huirne JA. Minimally invasive therapy for gynaecological symptoms related to a niche in the caesarean scar: a systematic review. BJOG. 2014 Jan;121(2):145-56. doi: 10.1111/1471-0528.12537.
    Results Reference
    result
    PubMed Identifier
    19499514
    Citation
    Osser OV, Jokubkiene L, Valentin L. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009 Jul;34(1):90-7. doi: 10.1002/uog.6395.
    Results Reference
    result
    PubMed Identifier
    27634054
    Citation
    Li Y, Gong L, Wu X, Gao H, Zheng H, Lan W. Randomized controlled trial of hysteroscopy or ultrasonography versus no guidance during D&C after uterine artery chemoembolization for cesarean scar pregnancy. Int J Gynaecol Obstet. 2016 Nov;135(2):158-162. doi: 10.1016/j.ijgo.2016.04.019. Epub 2016 Aug 5.
    Results Reference
    derived

    Learn more about this trial

    UACE Followed by Uterine Suction Curettage for the Treatment of Caesarean Scar Pregnancy

    We'll reach out to this number within 24 hrs