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Cesarean Scar PregnancyNCT04955028

MRI in Predicting Intraoperative Massive Hemorrhage for Cesarean Scar Pregnancy

An observational study of Cesarean Scar Pregnancy, run by Peking University Third Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

MRI features and clinical characteristics to predict massive hemorrhage during hysteroscopic treatment of CSP, and to aid the choice of treatment. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Cesarean Scar Pregnancy
How many people
300 participants
Where
No sites listed yet
Study dates
27 Jan 2015to 1 Jul 2019
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: patients with Cesarean scar pregnancy

Who may be able to join

  • 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.

Who cannot join

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

About this study

Official title: The Application Values of MRI in Predicting Intraoperative Massive Hemorrhage for Cesarean Scar Pregnancy

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

Read the 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.

Keywords
cesarean scar pregnancy, Ectopic pregnancy, Magnetic resonance imaging
Medical subject headings
Pregnancy, Ectopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04955028
Study groupRoleWhat they receive
intraoperative massive hemorrhageblood 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 groupblood loss of <200 mL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. intraoperative massive hemorrhage

    intraoperative blood loss

    Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2021
  2. Study start27 Jan 2015
  3. Primary completion24 Jun 2019
  4. Study completion1 Jul 2019

Resources

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04955028
Sponsor's protocol ID
M2019442
Status last verified
Jun 2021
First submitted
29 Jun 2021
Last updated
8 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cesarean Scar Pregnancy, run by Peking University Third Hospital.

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 1 inclusion and 1 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 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

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 massive hemorrhage (time frame: intraoperative). 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 8 Jul 2021.

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