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MRI in Predicting Intraoperative Massive Hemorrhage for Cesarean Scar Pregnancy

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04955028
Collaborator
(none)
300
Enrollment
53.1
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Cesarean scar pregnancy (CSP) is a rare ectopic pregnancy occurring in cesarean section of previous cesarean delivery. The incidence of CSP was 1 in 1,800-2,216 of all deliveries reported in 2006. However, the incidence of CSP is increasing worldwide, especially in China, owing to the rapidly increasing rate of cesarean sections and second-child births since 2015.

    CSP can lead to life-threatening complications, such as massive hemorrhage, uterine rupture, and loss of fertility. Therefore, immediate termination of pregnancy is recommended once a correct diagnosis is made. At present, there is still no standard treatment for CSP. Current treatments mainly include medical and surgical interventions (uterine artery embolization, suction curettage, local resection by hysteroscopy or laparoscopy, and hysterectomy). At our hospital, local resection by hysteroscopy is widely used; however, uncontrollable hemorrhage still occurs during treatment. It is of great importance to predict massive hemorrhage for clinical decision making.

    Classically, transvaginal ultrasonography (TVUS) is the preferred imaging modality to diagnose CSP. However, patient factors, such as obesity, presence of bowel gas, and pain, combined with operator experience, may limit the usefulness of TVUS. Owing to excellent soft tissue contrast, the capacity of multiple dimensional images, and an excellent anatomical overview, MRI has become an important supplement to evaluate CSP and cesarean section scar (CSS). Sagittal T2-weighted imaging can be used to clearly visualize the gestational sac (GS) and the CSS of a CSP and show detailed features, including the type of CSP, the degree of CSS weakness, and the relationship between the CSP and adjacent structures. Hoffmann et al. studied 25 asymptomatic pregnant women who had undergone one previous cesarean section and found that MRI showed good inter- and intra-rater reliability in measuring lower uterine segment thickness with a low observer dependency. MRI is an additional diagnostic tool that can be used to assess the lower uterine segment in women who have undergone previous cesarean section.

    To our knowledge, no previous studies have explored the relationship between MRI and intraoperative massive hemorrhage in patients with CSP. The arm of this study was to investigate the ability of clinical characteristics and MRI features to predict massive hemorrhage during hysteroscopic treatment of CSP, and to aid the choice of treatment.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    The Application Values of MRI in Predicting Intraoperative Massive Hemorrhage for Cesarean Scar Pregnancy
    Actual Study Start Date :
    Jan 27, 2015
    Actual Primary Completion Date :
    Jun 24, 2019
    Actual Study Completion Date :
    Jul 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. intraoperative massive hemorrhage [intraoperative]

      intraoperative blood loss

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.
    Exclusion Criteria:
    • (1) twin pregnancy ; (2) preoperative methotrexate use; (3) previous incomplete CSP resection performed at other hospitals; (4) Surgical failure with incomplete CSP removal.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking University Third Hospital

    Investigators

    • Study Director: Jianyu Liu, Dr, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT04955028
    Other Study ID Numbers:
    • M2019442
    First Posted:
    Jul 8, 2021
    Last Update Posted:
    Jul 8, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking University Third Hospital
    cesarean scar pregnancy
    Ectopic pregnancy
    Magnetic resonance imaging
    Additional relevant MeSH terms:
    Hemorrhage

    Study Results

    No Results Posted as of Jul 8, 2021