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Abnormal Placenta Plant Disease Early Diagnosis and Individualized Treatment Research

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ClinicalTrials.gov Identifier: NCT02946749
Recruitment Status : Unknown
Verified July 2017 by Shanghai First Maternity and Infant Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 27, 2016
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai First Maternity and Infant Hospital

Study Description
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Brief 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. 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.

Condition or disease
Scarred Uterus

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
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abnormal Placenta Plant Disease Early Diagnosis and Individualized Treatment Research
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Placenta implanted [ Time Frame: up to 37 gestational weeks ]

Secondary Outcome Measures :
  1. Placenta previa [ Time Frame: up to 37 gestational weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
pregnant women with scar uterus
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946749


Contacts
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Contact: Hao Ying, PHD 13371985049 stephenying2011@126.com
Contact: Chuanlu Xu, Master 13661631960 xuchuanlu@foxmail.com

Sponsors and Collaborators
Shanghai First Maternity and Infant Hospital
Investigators
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Principal Investigator: Hao Ying, PHD Shanghai First Maternity and Infant Hospital
More Information
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Responsible Party: Shanghai First Maternity and Infant Hospital
ClinicalTrials.gov Identifier: NCT02946749    
Other Study ID Numbers: Yinghao
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There are 6 hospitals participated this study, we need get their agreement to share data.
Keywords provided by Shanghai First Maternity and Infant Hospital:
Scar pregnancy
Placenta planting abnormal disease
Early diagnosis
Individualized treatment
Additional relevant MeSH terms:
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Disease
Pathologic Processes