Treatment of Caesarean Scar Pregnancy

NCT01916746 | Unknown DMC

• 2 other identifiers: CHEN-CSPCSP-2013
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Caesarean Scar Pregnancy

Keywords

Caesarean Scar Pregnancy; Transvaginal Resection; treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Baseline clinical characteristic of patient when diagnosed with CSP

  one week

• three year recurrence rate

  three years after the procedure

Study Arms (1)

transvaginal resection of pregnancy tissue

EXPERIMENTAL

Procedure: transvaginal resection of pregnancy tissue

Interventions

transvaginal resection of pregnancy tissue PROCEDURE

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.

transvaginal resection of pregnancy tissue

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• pre-operative diagnosed as CSP
• hemodynamic stability

You may not qualify if:

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

Sponsors & Collaborators

• Shu-Qin Chen: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Study Officials

• Chen Shu-Qin, M.D&PhD.

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

• Li Jin-Bo, M.D

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Yao Shu-Zhong, M.D&Ph.D

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Chen Shu-Qin, PhD & MD

CONTACT

+862087332200; chenshuqin1021@163.com

Li Jin-Bo, M.D

CONTACT

+862087332200; bobolee2004@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor of gynaecology and obstetrics

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: August 6, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Last Updated: August 6, 2013

Record last verified: 2013-01

Locations

CN (1)