CClinicalTrials.gg
Status unknownNCT01916746CSPUpdated Aug 6, 2013

Treatment of Caesarean Scar Pregnancy

An interventional study of transvaginal resection of pregnancy tissue in Caesarean Scar Pregnancy, sponsored by Shu-Qin Chen. Status unknown at 1 site in China. Open to female participants. Per ClinicalTrials.gov, last updated 2013-08-06.

Sponsored by Shu-Qin Chen · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Sex
Female
01

Study 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).

02

Conditions studied

  • Caesarean Scar Pregnancy

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Keywords

  • Caesarean Scar Pregnancy
  • Transvaginal Resection
  • treatment
03

In context

Cicatrix

306 studies on the registry are indexed under Cicatrix; 50 are open to participants now.

This study's planned enrollment of 150 is above the median of 39 across 250 interventional studies indexed under Cicatrix.

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Lead sponsor

Shu-Qin Chen is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • pre-operative diagnosed as CSP
  • hemodynamic stability

Exclusion criteria

Exclusion Criteria:

  • cervical pregnancy
  • incomplete abortion
  • gestational trophoblastic disease
  • diagnosis unidentified
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    transvaginal resection of pregnancy tissue

    Procedure: transvaginal resection of pregnancy tissue

Interventions

  • Proceduretransvaginal 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one week

  2. 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.

    Time frame: six months

Secondary outcomes

  1. 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

    Time frame: one week

  2. 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.

    Time frame: three years after the procedure

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Sun Yat-sen University
    GuangZhou, Guangdong 510080, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01916746
Lead sponsor
Shu-Qin Chen
Responsible party
Shu-Qin Chen (associate professor of gynaecology and obstetrics, First Affiliated Hospital, Sun Yat-Sen University) — Sponsor-investigator
First posted
Aug 6, 2013
Start date
Jan 2013
Primary completion
Dec 2015 (estimated)
Last update
Aug 6, 2013

Study contacts

Chen Shu-Qin, PhD & MD
Contact
chenshuqin1021@163.com
+862087332200 ext. 8342
Li Jin-Bo, M.D
Contact
bobolee2004@aliyun.com
+862087332200 ext. 8342
Chen Shu-Qin, M.D&PhD.
study director · First Affiliated Hospital, Sun Yat-Sen University
Li Jin-Bo, M.D
principal investigator · First Affiliated Hospital, Sun Yat-Sen University
Yao Shu-Zhong, M.D&Ph.D
study chair · First Affiliated Hospital, Sun Yat-Sen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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