NCT04955028

Brief Summary

MRI features and clinical characteristics to predict massive hemorrhage during hysteroscopic treatment of CSP, and to aid the choice of treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

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 27, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

4.4 years

First QC Date

June 29, 2021

Last Update Submit

June 29, 2021

Conditions

Cesarean Scar Pregnancy

Keywords

cesarean scar pregnancyEctopic pregnancyMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • intraoperative massive hemorrhage

    intraoperative blood loss

    intraoperative

Study Arms (2)

intraoperative massive hemorrhage

blood loss of ≥200 mL with or without artery embolization (UAE) or local CSP resection by laparoscopy or laparotomy as additional interventions.

the non-massive hemorrhage group

blood loss of \<200 mL

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with Cesarean scar pregnancy

You may qualify if:

  • patients were clinically diagnosed with CSP, which was confirmed by surgery and pathological assessment. Patients underwent local resection by hysteroscopy between January 2015 and June 2019 in our hospital. All patients underwent MRI within 3 days before surgery.

You may not qualify if:

  • (1) twin pregnancy ; (2) preoperative methotrexate use; (3) previous incomplete CSP resection performed at other hospitals; (4) Surgical failure with incomplete CSP removal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jianyu Liu, Dr

    Peking University Third Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 8, 2021

Study Start

January 27, 2015

Primary Completion

June 24, 2019

Study Completion

July 1, 2019

Last Updated

July 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share