Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women
1 other identifier
observational
1,500
1 country
1
Brief Summary
This study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2018
CompletedFirst Posted
Study publicly available on registry
December 13, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJune 9, 2021
June 1, 2021
3 years
December 5, 2018
June 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with postpartum hemorrhage
Blood loss \> 1000ml during cesarean section or \> 500 ml during vaginal delivery
24 hours after delivery
Secondary Outcomes (9)
Number of Participants with antepartum hemorrhage
From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks
Number of Participants with preterm birth
From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks
Number of Participants with very preterm birth
From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks
Number of participant needed for blood transfusion
72 hours after delivery
Number of urological injury
72 hours after delivery
- +4 more secondary outcomes
Study Arms (2)
Placenta Previa
Pregnant women is diagnosed with placenta previa after delivery. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.
None-Placenta Previa
Pregnant women is diagnosed without placenta previa after delivery. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.
Eligibility Criteria
Pregnant women is diagnosed with placenta previa after delivery and their matched pregnant women.
You may qualify if:
- Single Pregnancy
- Informed consent
- Fetal gestational age 28 to \< 42 weeks
You may not qualify if:
- Multiple pregnancy
- Refuses to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, 528000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2018
First Posted
December 13, 2018
Study Start
January 1, 2019
Primary Completion
December 31, 2021
Study Completion
June 30, 2022
Last Updated
June 9, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Six months after completion of the study