Treatment of Caesarean Scar Pregnancy

Overview

The aim of this study is to further demonstrate the safety and effectiveness of transvaginal resection of pregnancy tissue in the treatment of Caesarean Scar Pregnancy (CSP).

Full Title of Study: “Safety and Effectiveness of Transvaginal Resection of Pregnancy Tissue in the Treatment of Caesarean Scar Pregnancy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Interventions

  • Procedure: transvaginal resection of pregnancy tissue
    • Patient were under general anaesthesia, placed in a dorsal lithotomy position and the bladder emptied. Expose, grasp and traction the cervix. And adrenaline (600 ug/l; 10-20 ml) was injected submucosally at the level of the cervicovaginal junction. An incision was made at the anterior cervicovaginal junction, and the bladder was dissected away until the anterior peritoneal reflection was identified. The anterior drawing hook was inserted into the vaginal incision to retract the bladder upwards. The CSP was identified as a’purple bulge’ located in the anterior part of the lower uterine segment. A transverse incision was made over the most prominent area of the bulge. Ectopic pregnancy tissue inside the bulge was removed, and suction curettage through the incision on the uterus isthmus was subsequently performed. The edges of the incision were trimmed with scissors, and the myometrial and vaginal defects were closed with a continuous locking suture using 2-0 absorbable sutures.

Arms, Groups and Cohorts

  • Experimental: transvaginal resection of pregnancy tissue

Clinical Trial Outcome Measures

Primary Measures

  • The safety of transvaginal resection of pregnancy tissue in the treatment of CSP.
    • Time Frame: one week
    • index of blood loss, haemoglobin decrease(post-operation day 2 minus pre-operation), operation time, perioperation complications,change to other treatment procedure are collected to evaluate the safety of this procedure.
  • the effectiveness of transvaginal resection of pregnancy tissue in the treatment of CSP.
    • Time Frame: six months
    • serum hCG are measured every week till post-operation till it resolute to normal level. and transvaginal ultrasound are performed every month post-operation till there is no sign of any pregnancy residues.

Secondary Measures

  • Baseline clinical characteristic of patient when diagnosed with CSP
    • Time Frame: one week
    • age, gravity and parity, previous caesarean section times, interval from last caesarean section, gestation age when diagnosed, pre-treatment human chorionic gonadotropin(hCG) level and ultrasound characteristic details are collected to investigate the relation between these index and CSP
  • three year recurrence rate
    • Time Frame: three years after the procedure
    • the following pregnancy result of patient are inquired every year till three years post-operative to evaluate the influence of this procedure on further pregnancy.

Participating in This Clinical Trial

Inclusion Criteria

  • pre-operative diagnosed as CSP – hemodynamic stability Exclusion Criteria:

  • cervical pregnancy – incomplete abortion – gestational trophoblastic disease – diagnosis unidentified

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shu-Qin Chen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Shu-Qin Chen, associate professor of gynaecology and obstetrics – First Affiliated Hospital, Sun Yat-Sen University
  • Overall Official(s)
    • Chen Shu-Qin, M.D&PhD., Study Director, First Affiliated Hospital, Sun Yat-Sen University
    • Li Jin-Bo, M.D, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
    • Yao Shu-Zhong, M.D&Ph.D, Study Chair, First Affiliated Hospital, Sun Yat-Sen University
  • Overall Contact(s)
    • Chen Shu-Qin, PhD & MD, +862087332200, chenshuqin1021@163.com

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