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Treatment of Caesarean Scar Pregnancy (CSP)

Primary Purpose

Caesarean Scar Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transvaginal resection of pregnancy tissue
Sponsored by
Shu-Qin Chen
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, Transvaginal Resection, treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • pre-operative diagnosed as CSP
  • hemodynamic stability

Exclusion Criteria:

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

Sites / Locations

  • The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transvaginal resection of pregnancy tissue

Arm Description

Outcomes

Primary Outcome Measures

The safety of transvaginal resection of pregnancy tissue in the treatment of CSP.
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.
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
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
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.

Full Information

First Posted
July 25, 2013
Last Updated
August 2, 2013
Sponsor
Shu-Qin Chen
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1. Study Identification

Unique Protocol Identification Number
NCT01916746
Brief Title
Treatment of Caesarean Scar Pregnancy
Acronym
CSP
Official Title
Safety and Effectiveness of Transvaginal Resection of Pregnancy Tissue in the Treatment of Caesarean Scar Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shu-Qin Chen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

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, Transvaginal Resection, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transvaginal resection of pregnancy tissue
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
transvaginal resection of pregnancy tissue
Intervention Description
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.
Primary Outcome Measure Information:
Title
The safety of transvaginal resection of pregnancy tissue in the treatment of CSP.
Description
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.
Time Frame
one week
Title
the effectiveness of transvaginal resection of pregnancy tissue in the treatment of CSP.
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Baseline clinical characteristic of patient when diagnosed with CSP
Description
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
Time Frame
one week
Title
three year recurrence rate
Description
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.
Time Frame
three years after the procedure

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pre-operative diagnosed as CSP hemodynamic stability Exclusion Criteria: cervical pregnancy incomplete abortion gestational trophoblastic disease diagnosis unidentified
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Shu-Qin, PhD & MD
Phone
+862087332200
Ext
8342
Email
chenshuqin1021@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Jin-Bo, M.D
Phone
+862087332200
Ext
8342
Email
bobolee2004@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Shu-Qin, M.D&PhD.
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Li Jin-Bo, M.D
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yao Shu-Zhong, M.D&Ph.D
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Shu-Qin, M.D&Ph.D
Phone
+862087332200
Ext
8342
Email
chenshuqin1021@163.com
First Name & Middle Initial & Last Name & Degree
LI Jin-Bo, M.D
Phone
+862087332200
Ext
8342
Email
bobolee2004@aliyun.com
First Name & Middle Initial & Last Name & Degree
Li Jin-Bo, M.D
First Name & Middle Initial & Last Name & Degree
Fan Li, M.D

12. IPD Sharing Statement

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Treatment of Caesarean Scar Pregnancy

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