Scarred UterusNCT02946749
Abnormal Placenta Plant Disease Early Diagnosis and Individualized Treatment Research
An observational study of Scarred Uterus, run by Shanghai First Maternity and Infant Hospital.
Trial summary
As the "two-child" policy implementation, caesarean women's clinical pregnancy is a huge problem again, Especially the placenta planting abnormal disease is a serious threat to the maternal health and life. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Scarred Uterus
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women with scar uterus
Who may be able to join
- Single pregnancies with once cesarean section history
- see a doctor before gestational 8 weeks in our study center
- will continue to pregnancy, high patient compliance
Who cannot join
- twins or multiple pregnancies
- hysteromyoma or adenomyoma stripping history
- history of intrauterine adhesions
Trial locations and contacts
No sites are listed yet.
About this study
As the "two-child" policy implementation, caesarean women's clinical pregnancy is a huge problem again, Especially the placenta planting abnormal disease is a serious threat to the maternal health and life. Through this research, the investigators can obtain relevant epidemiological data and provide objective data for the department of public health policy; Predicting an placenta abnormal planting early diagnosis model was constructed, it will fill the blank in this field, and high-risk groups in the early stages of pregnancy will be taken proper disposal, the related complications will be reduced to ensure the safety of maternal.
Read the detailed description
This study focus on four hands: (1) to investigate different types of gestational sac implantation for pregnancy in caesarean women of childbearing age;(2) to explore the relationship between abnormal placenta planting disease in middle-late pregnancy and the different types of scar pregnancy (3) to explore the the value of ultrasound and serological markers for early diagnosis of placenta planting disease from scar pregnancy; (4) to compare the end and the influence of health economy of different termination method on scar pregnancy.
- Conditions
- Scarred Uterus
- Keywords
- Scar pregnancy, Placenta planting abnormal disease, Early diagnosis, Individualized treatment
- Medical subject headings
- Disease
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 |
|---|---|---|
| Shanghai First Maternity and Infant Hospital | Not described | |
| the Putuo District Maternity and Child Health Care Hospital | Not described | |
| the Xinhua hospital affiliated to Shanghai jiaotong University | Not described | |
| The Sixth people's hospital of Shanghai | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placenta implanted
Measured: up to 37 gestational weeks
Secondary outcomes (1)
Placenta previa
Measured: up to 37 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scarred UterusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Ying, PHD, Principal investigator, Shanghai First Maternity and Infant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946749
- Sponsor's protocol ID
- Yinghao
- Status last verified
- Jul 2017
- First submitted
- 22 Oct 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: There are 6 hospitals participated this study, we need get their agreement to share data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abnormal Placenta Plant Disease Early Diagnosis and Individualized Treatment Research
- ClinicalTrials.gov ID
- NCT02946749
- Acronym / sponsor ID
- Yinghao
- Conditions
- Scarred Uterus
- Keywords
- Scar pregnancy, Placenta planting abnormal disease, Early diagnosis, Individualized treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 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.
As the "two-child" policy implementation, caesarean women's clinical pregnancy is a huge problem again, Especially the placenta planting abnormal disease is a serious threat to the maternal health and life. Through this research, the investigators can obtain relevant epidemiological data and provide objective data for the department of public health policy; Predicting an placenta abnormal planting early diagnosis model was constructed, it will fill the blank in this field, and high-risk groups in the early stages of pregnancy will be taken proper disposal, the related complications will be reduced to ensure the safety of maternal.
Detailed description
This study focus on four hands: (1) to investigate different types of gestational sac implantation for pregnancy in caesarean women of childbearing age;(2) to explore the relationship between abnormal placenta planting disease in middle-late pregnancy and the different types of scar pregnancy (3) to explore the the value of ultrasound and serological markers for early diagnosis of placenta planting disease from scar pregnancy; (4) to compare the end and the influence of health economy of different termination method on scar pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Shanghai First Maternity and Infant Hospital | – | – |
| the Putuo District Maternity and Child Health Care Hospital | – | – |
| the Xinhua hospital affiliated to Shanghai jiaotong University | – | – |
| The Sixth people's hospital of Shanghai | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women with scar uterus
Key inclusion criteria (3 listed)
- Single pregnancies with once cesarean section history
- see a doctor before gestational 8 weeks in our study center
- will continue to pregnancy, high patient compliance
Key exclusion criteria (3 listed)
- twins or multiple pregnancies
- hysteromyoma or adenomyoma stripping history
- history of intrauterine adhesions
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
Placenta implanted
Time frame: up to 37 gestational weeks
1 secondary outcome
Placenta previa
Time frame: up to 37 gestational weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: Undecided. There are 6 hospitals participated this study, we need get their agreement to share data.
Related trials for Scarred Uterus
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Recruiting
Platelet Rich Plasma for Uterine Scar
Cesarean Section Complications, Uterine Bleeding
Recruiting
Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women
Isthmocele, Cesarean Scar Diverticula
Active, not recruiting
Comparison of Purse String Suture vs Transverse Mattress Suture to Maintain Hemostasis in Thinned-out Caesarean Sections Scars
Thinned-out Lower Uterine Segment Scar Previous Cesarean Section
Active, not recruitingObservational study
Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination
Uterine Fibroids, Adenomyosis
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.
Hao Ying, PHD principal investigator
Shanghai First Maternity and Infant Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Scarred Uterus, run by Shanghai First Maternity and Infant 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 3 inclusion and 3 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 1 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Ying, PHD (13371985049, stephenying2011@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placenta implanted (time frame: up to 37 gestational weeks). 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 1 Aug 2017.