Objective Analysis of Caesarean Scar Pregnancy

February 17, 2024 updated by: Jianwen Du, Chengde Central Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chengde, China, 067000
        • Chengde Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
low-risk group
Procedure: ultrasound-guided/hysteroscopic curettage
ultrasound-guided/hysteroscopic curettage
high-risk group
Procedure: Procedure/Surgery: laparoscopic removal of the pregnancy lesion
laparoscopic removal of the pregnancy lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative blood loss
Time Frame: during surgery
The patient's blood loss during surgery. Check the blood volume in ml of the aspirator reservoir.
during surgery
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.
Within 1 week
serum β-HCG levels
Time Frame: Within 2 weeks after the operation
The time taken for serum β-HCG levels to return to normal
Within 2 weeks after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengde Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2019

Primary Completion (Actual)

December 23, 2022

Study Completion (Actual)

December 25, 2022

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Estimated)

February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ChengdeCentralHospital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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