Caesarean Scar PregnancyNCT06276790
Objective Analysis of Caesarean Scar Pregnancy
An observational study of Caesarean Scar Pregnancy and Ultrasound Scoring System, run by Chengde Central Hospital at 1 site in China.
Trial summary
This study uses a systematic scoring method combined with clinical and ultrasound data to comprehensively evaluate patient conditions and explore the guiding value of the ultrasound quantitative scoring system for selecting the surgical approach for caesarean scar pregnancy. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Caesarean Scar Pregnancy, Ultrasound Scoring System
- What is being tested?
- ultrasound-guided/hysteroscopic curettage and Procedure/Surgery: laparoscopic removal of the pregnancy lesion
- Type of treatment
- Surgery or procedure
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2019to 25 Dec 2022
- Phase
- Observational
- 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 20 years and older
- Women only
- Adult, Older adult
Study population: A total of 117 patients with caesarean scar pregnancy admitted to the Obstetrics and Gynecology Inpatient Area of Chengde Central Hospital, China, from January 2019 to December 2022 were selected for this study.
Who may be able to join
- history of at least one previous caesarean section
- symptoms suggestive of caesarean scar pregnancy, such as unexplained abnormal vaginal bleeding, abdominal pain, cervical pain or abnormal uterine activity during pregnancy
- amenorrhea ≤84 days
- ultrasound examination suggesting a single gestational sac with intact morphology
- stable maternal vital signs
Who cannot join
- mass-type caesarean scar pregnancy
- previous medication or surgical treatment before ultrasound examination
- haemodynamically unstable patients
- patients with surgical contraindications
- incomplete or lost follow-up clinical data
- patients with severe medical conditions such as hypertension, diabetes, hyperthyroidism and haemophilia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Predictive Value of an Ultrasound Quantitative Scoring System for Treatment Method Selection in Patients With Caesarean Scar Pregnancy: A Single-Centre Retrospective Study
This study uses a systematic scoring method combined with clinical and ultrasound data to comprehensively evaluate patient conditions and explore the guiding value of the ultrasound quantitative scoring system for selecting the surgical approach for caesarean scar pregnancy.
- Being tested
- ultrasound-guided/hysteroscopic curettage, Procedure/Surgery: laparoscopic removal of the pregnancy lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided/hysteroscopic curettageProcedure or surgery
ultrasound-guided/hysteroscopic curettage
Procedure/Surgery: laparoscopic removal of the pregnancy lesionProcedure or surgery
laparoscopic removal of the pregnancy lesion
| Study group | Role | What they receive |
|---|---|---|
| low-risk group | Not described Receives: Procedure: ultrasound-guided/hysteroscopic curettage | |
| high-risk group | Not described Receives: Procedure: Procedure/Surgery: laparoscopic removal of the pregnancy lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss
The patient's blood loss during surgery. Check the blood volume in ml of the aspirator reservoir.
Measured: during surgery
length of hospital stay
Number of days the patient was hospitalized. Discharge assessment: vital signs stable, no abdominal pain, no active bleeding.
Measured: Within 1 week
serum β-HCG levels
The time taken for serum β-HCG levels to return to normal
Measured: Within 2 weeks after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start18 Jan 2019
- Primary completion23 Dec 2022
- Study completion25 Dec 2022
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengde Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jianwen Du, Chengde Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276790
- Sponsor's protocol ID
- ChengdeCentralHospital
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of an Ultrasound Quantitative Scoring System for Treatment Method Selection in Patients With Caesarean Scar Pregnancy: A Single-Centre Retrospective Study
- ClinicalTrials.gov ID
- NCT06276790
- Acronym / sponsor ID
- ChengdeCentralHospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Chengde Central HospitalOther government
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 26 Feb 2024 (actual)
- 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.
This study uses a systematic scoring method combined with clinical and ultrasound data to comprehensively evaluate patient conditions and explore the guiding value of the ultrasound quantitative scoring system for selecting the surgical approach for caesarean scar pregnancy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-risk group | – | Procedure: ultrasound-guided/hysteroscopic curettage |
| high-risk group | – | Procedure: Procedure/Surgery: laparoscopic removal of the pregnancy lesion |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- A total of 117 patients with caesarean scar pregnancy admitted to the Obstetrics and Gynecology Inpatient Area of Chengde Central Hospital, China, from January 2019 to December 2022 were selected for this study.
Key inclusion criteria (5 listed)
- history of at least one previous caesarean section
- symptoms suggestive of caesarean scar pregnancy, such as unexplained abnormal vaginal bleeding, abdominal pain, cervical pain or abnormal uterine activity during pregnancy
- amenorrhea ≤84 days
- ultrasound examination suggesting a single gestational sac with intact morphology
- stable maternal vital signs
Key exclusion criteria (6 listed)
- mass-type caesarean scar pregnancy
- previous medication or surgical treatment before ultrasound examination
- haemodynamically unstable patients
- patients with surgical contraindications
- incomplete or lost follow-up clinical data
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 |
|---|---|---|
| ultrasound-guided/hysteroscopic curettageultrasound-guided/hysteroscopic curettage | Procedure or surgery | low-risk group |
| Procedure/Surgery: laparoscopic removal of the pregnancy lesionlaparoscopic removal of the pregnancy lesion | Procedure or surgery | high-risk group |
Primary outcome
intraoperative blood loss
Time frame: during surgery
The patient's blood loss during surgery. Check the blood volume in ml of the aspirator reservoir.
length of hospital stay
Time frame: Within 1 week
Number of days the patient was hospitalized. Discharge assessment: vital signs stable, no abdominal pain, no active bleeding.
serum β-HCG levels
Time frame: Within 2 weeks after the operation
The time taken for serum β-HCG levels to return to normal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caesarean Scar Pregnancy and Ultrasound Scoring System, run by Chengde Central Hospital 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 26 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative blood loss (time frame: during surgery). The study lists 3 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 26 Feb 2024.