- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02946749
Abnormal Placenta Plant Disease Early Diagnosis and Individualized Treatment Research
July 30, 2017 updated by: Shanghai First Maternity and Infant Hospital
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
pregnant women with scar uterus
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- twins or multiple pregnancies
- hysteromyoma or adenomyoma stripping history
- history of intrauterine adhesions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Placenta implanted
Time Frame: up to 37 gestational weeks
|
up to 37 gestational weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Placenta previa
Time Frame: up to 37 gestational weeks
|
up to 37 gestational weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hao Ying, PHD, Shanghai First Maternity and Infant Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
October 22, 2016
First Submitted That Met QC Criteria
October 25, 2016
First Posted (Estimate)
October 27, 2016
Study Record Updates
Last Update Posted (Actual)
August 1, 2017
Last Update Submitted That Met QC Criteria
July 30, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Yinghao
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
There are 6 hospitals participated this study, we need get their agreement to share data.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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