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

NCT02357095 | Completed DMC

• 1 other identifier: CSPT
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caesarean Scar Pregnancy

Keywords

Caesarean Scar Pregnancy; uterine artery chemo-embolization; treatment

Outcome Measures

Primary Outcomes (2)

• 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.

  two months

• 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.

  two months

Secondary Outcomes (1)

• Composite outcome measure：Baseline clinical characteristic of patient when diagnosed with CSP

  one week

Study Arms (3)

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.

Procedure: monitoring

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).

Procedure: monitoring

no monitoring

EXPERIMENTAL

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

Procedure: monitoring

Interventions

monitoring PROCEDURE

uterine artery chemo-embolization combined with suction curettage under different monitoring methods,such as hysteroscopic monitoring,ultrasonography monitoring and no monitoring

hysteroscopic monitoring; no monitoring; ultrasonography monitoring

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pre-operative diagnosed as CSP;hemodynamic stability

You may not qualify if:

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

Sponsors & Collaborators

• Maternal and Child Health Hospital of Hubei Province: lead

Related Publications (11)

• 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.

  PMID: 12666214 RESULT

• 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.

  PMID: 21838169 RESULT

• 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.

  PMID: 15924549 RESULT

• 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.

  PMID: 19527897 RESULT

• 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.

  PMID: 22516620 RESULT

• 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.

  PMID: 19087704 RESULT

• 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.

  PMID: 23718134 RESULT

• 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.

  PMID: 23206476 RESULT

• 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.

  PMID: 24373589 RESULT

• 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.

  PMID: 19499514 RESULT

• 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.

  PMID: 27634054 DERIVED

Study Officials

• Wu X-Feng, Ph.D & MD

  Maternal and Child Health Hospital of Hubei Province,Wuhan,Hubei,PR China

  STUDY CHAIR

• Gao Han, Bachelor

  Maternal and Child Health Hospital of Hubei Province,Wuhan,Hubei,PR China

  PRINCIPAL INVESTIGATOR

• Ma Quan-Fu, Ph.D & MD

  Maternal and Child Health Hospital of Hubei Province,Wuhan,Hubei,PR China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologist

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: February 6, 2015
• Study Start: June 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 6, 2015

Record last verified: 2015-02