Treatment of Caesarean Scar Pregnancy (CSP)

August 2, 2013 updated by: Shu-Qin Chen

Safety and Effectiveness of Transvaginal Resection of Pregnancy Tissue in the Treatment of Caesarean Scar Pregnancy

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-Sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Li Jin-Bo, M.D
        • Sub-Investigator:
          • Fan Li, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pre-operative diagnosed as CSP
  • hemodynamic stability

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one week
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.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one week
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.
three years after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 6, 2013

Study Record Updates

Last Update Posted (Estimate)

August 6, 2013

Last Update Submitted That Met QC Criteria

August 2, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEN-CSP
  • CSP-2013 (Other Identifier: Hospital Ethical Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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