Treatment of Caesarean Scar Pregnancy (CSP)

This study is currently recruiting participants.
Verified January 2013 by First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Shu-Qin Chen, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01916746
First received: July 25, 2013
Last updated: August 2, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention
Caesarean Scar Pregnancy
Procedure: transvaginal resection of pregnancy tissue

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Transvaginal Resection of Pregnancy Tissue in the Treatment of Caesarean Scar Pregnancy

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • The safety of transvaginal resection of pregnancy tissue in the treatment of CSP. [ Time Frame: one week ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Baseline clinical characteristic of patient when diagnosed with CSP [ Time Frame: one week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transvaginal resection of pregnancy tissue 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pre-operative diagnosed as CSP
  • hemodynamic stability

Exclusion Criteria:

  • cervical pregnancy
  • incomplete abortion
  • gestational trophoblastic disease
  • diagnosis unidentified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01916746

Contacts
Contact: Chen Shu-Qin, PhD & MD +862087332200 ext 8342 chenshuqin1021@163.com
Contact: Li Jin-Bo, M.D +862087332200 ext 8342 bobolee2004@aliyun.com

Locations
China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University Recruiting
GuangZhou, Guangdong, China, 510080
Contact: Chen Shu-Qin, M.D&Ph.D    +862087332200 ext 8342    chenshuqin1021@163.com   
Contact: LI Jin-Bo, M.D    +862087332200 ext 8342    bobolee2004@aliyun.com   
Principal Investigator: Li Jin-Bo, M.D         
Sub-Investigator: Fan Li, M.D         
Sponsors and Collaborators
Shu-Qin Chen
Investigators
Study Director: Chen Shu-Qin, M.D&PhD. First Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Li Jin-Bo, M.D First Affiliated Hospital, Sun Yat-Sen University
Study Chair: Yao Shu-Zhong, M.D&Ph.D First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Shu-Qin Chen, associate professor of gynaecology and obstetrics, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01916746     History of Changes
Other Study ID Numbers: CHEN-CSP, CSP-2013
Study First Received: July 25, 2013
Last Updated: August 2, 2013
Health Authority: China: Ministry of Health

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
Caesarean Scar Pregnancy
Transvaginal Resection
treatment

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014