An observational study in Placenta Previa, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Assiut University · Observational
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.
Exclusion Criteria:
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 \> 2000 ml), and neonatal admission to neonatal intensive care unit (NICU).
80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 100 across 32 observational studies indexed under Placenta Previa.
Browse Placenta Previa studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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, disease).
Fetal major congenital anomalies
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Incidence of emergency cesarean section (CS)
CS that is indicated earlier than the elective planned date (36-37 weeks of gestation) due to bleeding or preterm labor
Time frame: 22 weeks to 37 weeks of gestation
Peri-operative blood loss
Amount of blood loss in ml during and up to 24 hours after delivery as measured by suction device and gravimetric measures
Time frame: Time between onset of cesarean section till 24 hours after the procedure
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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