NCT06276790

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

3.9 years

First QC Date

January 25, 2024

Last Update Submit

February 17, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • intraoperative blood loss

    The patient's blood loss during surgery. Check the blood volume in ml of the aspirator reservoir.

    during surgery

  • length of hospital stay

    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

    The time taken for serum β-HCG levels to return to normal

    Within 2 weeks after the operation

Study Arms (2)

low-risk group

Procedure: ultrasound-guided/hysteroscopic curettage

high-risk group

Procedure: Procedure/Surgery: laparoscopic removal of the pregnancy lesion

Interventions

ultrasound-guided/hysteroscopic curettage

low-risk group

laparoscopic removal of the pregnancy lesion

high-risk group

Eligibility Criteria

Age20 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengde Central Hospital

Chengde, 067000, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 26, 2024

Study Start

January 18, 2019

Primary Completion

December 23, 2022

Study Completion

December 25, 2022

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations