Treatment of Caesarean Scar Pregnancy

NCT ID: NCT01916746

Last Updated: 2013-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caesarean Scar Pregnancy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Caesarean Scar Pregnancy Transvaginal Resection treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

transvaginal resection of pregnancy tissue

Group Type EXPERIMENTAL

transvaginal resection of pregnancy tissue

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* pre-operative diagnosed as CSP
* hemodynamic stability

Exclusion Criteria

* cervical pregnancy
* incomplete abortion
* gestational trophoblastic disease
* diagnosis unidentified
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shu-Qin Chen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shu-Qin Chen

associate professor of gynaecology and obstetrics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chen Shu-Qin, M.D&PhD.

Role: STUDY_DIRECTOR

First Affiliated Hospital, Sun Yat-Sen University

Li Jin-Bo, M.D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Yao Shu-Zhong, M.D&Ph.D

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chen Shu-Qin, PhD & MD

Role: CONTACT

Phone: +862087332200

Email: [email protected]

Li Jin-Bo, M.D

Role: CONTACT

Phone: +862087332200

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chen Shu-Qin, M.D&Ph.D

Role: primary

LI Jin-Bo, M.D

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSP-2013

Identifier Type: OTHER

Identifier Source: secondary_id

CHEN-CSP

Identifier Type: -

Identifier Source: org_study_id