Magnetic Resonance ImagingNCT02933190
Fertility After Transvaginal Surgery or Uterine Artery Embolization Combined With Uterine Curettage in Patients With Cesarean Scar Pregnancy
A study testing transvaginal surgery；UAE and D&C in people with Magnetic Resonance Imaging and Ovarian Function, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial summary
To investigate the fertility in patients after treatment by transvaginal surgery or uterine artery embolization combined with uterine curettage Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Magnetic Resonance Imaging, Ovarian Function, Menstruation
- What is being tested?
- transvaginal surgery；UAE and D&C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder(24). All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.
Who cannot join
- All enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
Shanghai, Shanghai Municipality, 201204
Xipeng Wang, 86-13817806602, xipengwang@hotmail.com
About this study
To investigate the fertility in patients after treatment by transvaginal surgery or uterine artery embolization combined with uterine curettage
- Conditions
- Magnetic Resonance Imaging, Ovarian Function, Menstruation
- Being tested
- transvaginal surgery；UAE and D&C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal surgery；UAE and D&CProcedure or surgery
For cesarean scar pregnancy treatment
| Study group | Role | What they receive |
|---|---|---|
| CSP；transvaginal surgery；UAE and D&C | Other | Cesarean scar pregnancy (CSP) refers to the implantation of a gestational sac with the myometrium at the site of a previous cesarean scar Receives: Procedure: transvaginal surgery；UAE and D&C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of menstruation by questionnaire (days)
Measured: six months after treatment
Endocrine level by blood examination (FSH in IU/L)
Measured: six months after treatment
Volume of menstruation by questionnaire (in pictorial blood loss score)
Measured: six months after treatment
Secondary outcomes (3)
The length of the CSD by MRI (millimeter)
Measured: six months after treatment
The width of the CSD by MRI (millimeter)
Measured: six months after treatment
The depth of the CSD by MRI (millimeter)
Measured: six months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xipeng Wang, Study chair, Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933190
- Sponsor's protocol ID
- ShanghaiFMIH-CSP
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility After Transvaginal Surgery or Uterine Artery Embolization Combined With Uterine Curettage in Patients With Cesarean Scar Pregnancy
- ClinicalTrials.gov ID
- NCT02933190
- Acronym / sponsor ID
- ShanghaiFMIH-CSP
- Conditions
- Magnetic Resonance Imaging, Ovarian Function, Menstruation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Oct 2016 (estimated)
- 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.
To investigate the fertility in patients after treatment by transvaginal surgery or uterine artery embolization combined with uterine curettage
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSP；transvaginal surgery；UAE and D&C | Other | Procedure: transvaginal surgery；UAE and D&CCesarean scar pregnancy (CSP) refers to the implantation of a gestational sac with the myometrium at the site of a previous cesarean scar |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder(24). All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.
Key exclusion criteria (1 listed)
- All enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transvaginal surgery；UAE and D&CFor cesarean scar pregnancy treatment | Procedure or surgery | CSP；transvaginal surgery；UAE and D&C |
Primary outcome
Duration of menstruation by questionnaire (days)
Time frame: six months after treatment
Endocrine level by blood examination (FSH in IU/L)
Time frame: six months after treatment
Volume of menstruation by questionnaire (in pictorial blood loss score)
Time frame: six months after treatment
3 secondary outcomes
The length of the CSD by MRI (millimeter)
Time frame: six months after treatment
The width of the CSD by MRI (millimeter)
Time frame: six months after treatment
The depth of the CSD by MRI (millimeter)
Time frame: six months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Xipeng Wang study chair
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transvaginal surgery；UAE and D&C in people with Magnetic Resonance Imaging and Ovarian Function, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xipeng Wang (0086-13817806602, xipengwang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of menstruation by questionnaire (days) (time frame: six months after treatment). The study lists 3 primary outcomes in all. 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 14 Oct 2016.