Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589180
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Clinical Outcomes of Placenta Previa - an Individualized Scoring System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Outcomes of Placenta Previa - an Individualized Scoring System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study is to develop a machine learning -based prediction model for patients with placenta previa The model will be based on patient characteristics clinical assessment and disease features to predict disease course prognosis and establish an individualized plan of care Individualized management plan comprises timing of delivery mode of delivery need for hospital admission postpartum hemorrhage management plan and perioperative care
The primary outcome is to predict maternal complications primarily major antepartum hemorrhage APH defined as blood loss of 50-1000 ml
The primary outcome is to predict maternal complications primarily major antepartum hemorrhage APH defined as blood loss of 50-1000 ml
Detailed Description:
Study settings This multi-center study will invite at least 8 European-based tertiary centers Data will be retrospectively collected from January 2018 to December 2023 with a total follow-up of at least 6 weeks postpartum All women who will be diagnosed with PP during this period will be considered in the study
Inclusion Criteria
Pregnant women diagnosed with placenta previa at time of routine second trimester ultrasound 18 to 21 weeks of gestation
Aged 18 years old or above
Diagnosed with PP followed-up antenatally and delivered within the same center
Authorization to use anonymous patient data for research purposes
Exclusion Criteria
Inadequate documentation
Non-compliance to antenatal care
Previous 1 or more Cesarean deliveries
Previous uterine surgeries that approach the uterine cavity myomectomy
Known untreated uterine septum
Maternal chronic medical condition that is associated with higher risk of placental insufficiency including chronic hypertension pregestational diabetes chronic renal disease autoimmune disease
Fetal major congenital anomalies
Data Collection A standardized data collection spreadsheet is designed for this study and will be available for all participating centers The sheet will comprise drop lists for all nominal ordinal and binary variables to ensure consistency Target data will include patient demographics age parity gestational age at diagnosis mode of conception body mass index at booking and at delivery pregnancy interval hemoglobin at booking past medical and surgical history and the presence of any current complications in pregnancy Diagnostic information including placental location distance from internal os the presence of other placental abnormalities as well as diagnostic modality will be collected Follow-up from the 32-week scan and any subsequent scans will be explored and further follow-up information including hemoglobin levels bleeding episodes need for transfusion administration of steroids fetal growth and maternal and neonatal outcomes will be reviewed and collected
Data sheets will be sent on completion to the primary investigators to review and inquire on any unclear entry prior to data cleaning and data analysis
Secondary outcomes include prediction of need for antenatal transfusion emergency cesarean delivery and massive postpartum hemorrhage defined as blood loss ampgt 2000 ml and neonatal admission to neonatal intensive care unit NICU
Inclusion Criteria
Pregnant women diagnosed with placenta previa at time of routine second trimester ultrasound 18 to 21 weeks of gestation
Aged 18 years old or above
Diagnosed with PP followed-up antenatally and delivered within the same center
Authorization to use anonymous patient data for research purposes
Exclusion Criteria
Inadequate documentation
Non-compliance to antenatal care
Previous 1 or more Cesarean deliveries
Previous uterine surgeries that approach the uterine cavity myomectomy
Known untreated uterine septum
Maternal chronic medical condition that is associated with higher risk of placental insufficiency including chronic hypertension pregestational diabetes chronic renal disease autoimmune disease
Fetal major congenital anomalies
Data Collection A standardized data collection spreadsheet is designed for this study and will be available for all participating centers The sheet will comprise drop lists for all nominal ordinal and binary variables to ensure consistency Target data will include patient demographics age parity gestational age at diagnosis mode of conception body mass index at booking and at delivery pregnancy interval hemoglobin at booking past medical and surgical history and the presence of any current complications in pregnancy Diagnostic information including placental location distance from internal os the presence of other placental abnormalities as well as diagnostic modality will be collected Follow-up from the 32-week scan and any subsequent scans will be explored and further follow-up information including hemoglobin levels bleeding episodes need for transfusion administration of steroids fetal growth and maternal and neonatal outcomes will be reviewed and collected
Data sheets will be sent on completion to the primary investigators to review and inquire on any unclear entry prior to data cleaning and data analysis
Secondary outcomes include prediction of need for antenatal transfusion emergency cesarean delivery and massive postpartum hemorrhage defined as blood loss ampgt 2000 ml and neonatal admission to neonatal intensive care unit NICU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None