Treatment of Caesarean Scar Pregnancy (CSP)
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|ClinicalTrials.gov Identifier: NCT01916746|
Recruitment Status : Unknown
Verified January 2013 by Shu-Qin Chen, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was: Recruiting
First Posted : August 6, 2013
Last Update Posted : August 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Caesarean Scar Pregnancy||Procedure: transvaginal resection of pregnancy tissue||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Effectiveness of Transvaginal Resection of Pregnancy Tissue in the Treatment of Caesarean Scar Pregnancy|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2015|
|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.
- 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.
- 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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916746
|Contact: Chen Shu-Qin, PhD & MD||+862087332200 ext firstname.lastname@example.org|
|Contact: Li Jin-Bo, M.D||+862087332200 ext email@example.com|
|The First Affiliated Hospital of Sun Yat-sen University||Recruiting|
|GuangZhou, Guangdong, China, 510080|
|Contact: Chen Shu-Qin, M.D&Ph.D +862087332200 ext 8342 firstname.lastname@example.org|
|Contact: LI Jin-Bo, M.D +862087332200 ext 8342 email@example.com|
|Principal Investigator: Li Jin-Bo, M.D|
|Sub-Investigator: Fan Li, M.D|
|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|