Treatment of Caesarean Scar Pregnancy

Not Applicable

• Conditions: Caesarean Scar Pregnancy
• Interventions: Procedure: transvaginal resection of pregnancy tissue

• Registration Number: NCT01916746
• Lead Sponsor: Shu-Qin Chen

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-08-02
• Last Update Submitted: 2013-08-02
• Study First Posted: 2013-08-06
• Last Update Posted: 2013-08-06
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• pre-operative diagnosed as CSP
• hemodynamic stability

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
transvaginal resection of pregnancy tissue	transvaginal resection of pregnancy tissue	-

Primary Outcome Measures

Name	Time	Method
The safety of transvaginal resection of pregnancy tissue in the treatment of CSP.	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.	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 Outcome Measures

Name	Time	Method
Baseline clinical characteristic of patient when diagnosed with CSP	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	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 GuangZhou, Guangdong, China