Treatment of Caesarean Scar Pregnancy

Study Overview
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Brief Summary
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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).

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

Conditions
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Caesarean Scar Pregnancy

Intervention / Treatment
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* Procedure: transvaginal resection of pregnancy tissue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pre-operative diagnosed as CSP hemodynamic stability Exclusion Criteria: cervical pregnancy incomplete abortion gestational trophoblastic disease diagnosis unidentified
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transvaginal resection of pregnancy tissue<br> | Procedure: transvaginal resection of pregnancy tissue<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caesarean Scar Pregnancy, Transvaginal Resection, treatment