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.
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.
- Conditions
- Cesarean Scar Pregnancy
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted8 Jul 2021
- Study start27 Jan 2015
- Primary completion24 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Scar PregnancyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianyu Liu, Dr, Study director, Peking University Third Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application Values of MRI in Predicting Intraoperative Massive Hemorrhage for Cesarean Scar Pregnancy
- ClinicalTrials.gov ID
- NCT04955028
- Acronym / sponsor ID
- M2019442
- Conditions
- Cesarean Scar Pregnancy
- Keywords
- cesarean scar pregnancy, Ectopic pregnancy, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MRI features and clinical characteristics to predict massive hemorrhage during hysteroscopic treatment of CSP, and to aid the choice of treatment.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with Cesarean scar pregnancy
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- (1) twin pregnancy ; (2) preoperative methotrexate use; (3) previous incomplete CSP resection performed at other hospitals; (4) Surgical failure with incomplete CSP removal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intraoperative massive hemorrhage
Time frame: intraoperative
intraoperative blood loss
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianyu Liu, Dr study director
Peking University Third Hospital
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.