Caesarean Scar PregnancyCSPNCT01916746
Treatment of Caesarean Scar Pregnancy
A study testing transvaginal resection of pregnancy tissue in people with Caesarean Scar Pregnancy, run by Shu-Qin Chen at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Caesarean Scar Pregnancy
- What is being tested?
- transvaginal resection of pregnancy tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pre-operative diagnosed as CSP
- hemodynamic stability
Who cannot join
- cervical pregnancy
- incomplete abortion
- gestational trophoblastic disease
- diagnosis unidentified
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Chen Shu-Qin, M.D&Ph.D, +862087332200 ext. 8342, chenshuqin1021@163.com
LI Jin-Bo, M.D, +862087332200 ext. 8342, bobolee2004@aliyun.com
About this study
Official title: Safety and Effectiveness of Transvaginal Resection of Pregnancy Tissue in the Treatment of Caesarean Scar Pregnancy
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
- Being tested
- transvaginal resection of pregnancy tissue
- Keywords
- Caesarean Scar Pregnancy, Transvaginal Resection, treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal resection of pregnancy tissueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| transvaginal resection of pregnancy tissue | Experimental | Not described Receives: Procedure: transvaginal resection of pregnancy tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: six months
Secondary outcomes (2)
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
Measured: 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.
Measured: three years after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean Scar PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shu-Qin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shu-Qin Chen, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Chen Shu-Qin, M.D&PhD., Study director, First Affiliated Hospital, Sun Yat-Sen UniversityLi Jin-Bo, M.D, Principal investigator, First Affiliated Hospital, Sun Yat-Sen UniversityYao Shu-Zhong, M.D&Ph.D, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916746
- Sponsor's protocol ID
- CHEN-CSP
- Other IDs
- CSP-2013
- Acronym
- CSP
- Status last verified
- Jan 2013
- First submitted
- 25 Jul 2013
- Last updated
- 6 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Transvaginal Resection of Pregnancy Tissue in the Treatment of Caesarean Scar Pregnancy
- ClinicalTrials.gov ID
- NCT01916746
- Acronym / sponsor ID
- CSP / CHEN-CSP
- Conditions
- Caesarean Scar Pregnancy
- Keywords
- Caesarean Scar Pregnancy, Transvaginal Resection, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shu-Qin ChenUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transvaginal resection of pregnancy tissue | Experimental | Procedure: transvaginal resection of pregnancy tissue |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- pre-operative diagnosed as CSP
- hemodynamic stability
Key exclusion criteria (4 listed)
- cervical pregnancy
- incomplete abortion
- gestational trophoblastic disease
- diagnosis unidentified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transvaginal resection of pregnancy tissuePatient 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. | Procedure or surgery | transvaginal resection of pregnancy tissue |
Primary outcome
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.
2 secondary outcomes
Baseline clinical characteristic of patient when diagnosed with CSP
Time frame: one week
three year recurrence rate
Time frame: three years after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
Related trials for Caesarean Scar Pregnancy
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Surgical Evacuation Versus Methotrexate Injection in Treatment of Caesarean Scar Pregnancy [Clinical Trial ]
Caesarean Scar Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transvaginal resection of pregnancy tissue in people with Caesarean Scar Pregnancy, run by Shu-Qin Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Shu-Qin, PhD & MD (+862087332200 ext. 8342, chenshuqin1021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of transvaginal resection of pregnancy tissue in the treatment of CSP. (time frame: one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2013.