Treatment of Caesarean Scar Pregnancy

Caesarean Scar Pregnancy Clinical Trial

— CSP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01916746
• Other study ID #: CHEN-CSP
• Secondary ID: CSP-2013
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2013
• Last updated: August 2, 2013
• Start date: January 2013

Study information

• Verified date: January 2013
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Chen Shu-Qin, PhD & MD
• Phone: +862087332200
• Email: chenshuqin1021[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pre-operative diagnosed as CSP

• hemodynamic stability

Exclusion Criteria:

• cervical pregnancy

• incomplete abortion

• gestational trophoblastic disease

• diagnosis unidentified

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Caesarean Scar Pregnancy

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shu-Qin Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one week	Yes
Primary	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.	six months	Yes
Secondary	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	one week	No
Secondary	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.	three years after the procedure	No