Prediction of Bleeding in Placenta Previa
Prediction of Need of Blood Transfusion > 4 Units of Packed RBCS in Cases Diagnosed With Placenta Previa During Cesarean Section .
1 other identifier
observational
100
0 countries
N/A
Brief Summary
To assess the ability of clinical and sonographic variables to predict the need of blood transfusion \> 4 units of packed RBCS in women undergoing cesarian section for placenta previa .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2022
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
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
June 3, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedJuly 15, 2022
May 1, 2022
1 year
May 11, 2022
July 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Ability of a score of the study to predict the need for blood transfusion > 4 units of packed RBCs
It is a questionnaire Data collection of full personal history and obstetric and gynocological history and sonographic data . The data will be collected and entered on Microsoft access data base to be analysed using the Statistical Package for Social Science (SPSS Inc. ,Chicago,version 21) groups difference will be assessed by independent sample t-test and Chi square for prediction of receiving \>4 units 0f packed RBCS will be assessed by logistic Regression then a scoring system of factors that will prove independently significant . The predictive accuracy of the scoring system will be analysed using ROC curve
baseline
Secondary Outcomes (2)
The effect on morbidity of pregnant women .
baseline
The effect on mortality of pregnant women .
Baseline
Eligibility Criteria
women with placenta previa or accreta after 32 weeks
You may qualify if:
- women with placenta previa after 32 weeks
- women with placenta accreta after 32 weeks
You may not qualify if:
- abruption placenta
- unavilable or limited avilability of blood group
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (10)
Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-668. doi: 10.1097/AOG.0000000000001005.
PMID: 26244528BACKGROUNDRouse DJ, MacPherson C, Landon M, Varner MW, Leveno KJ, Moawad AH, Spong CY, Caritis SN, Meis PJ, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai BM, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Blood transfusion and cesarean delivery. Obstet Gynecol. 2006 Oct;108(4):891-7. doi: 10.1097/01.AOG.0000236547.35234.8c.
PMID: 17012451BACKGROUNDSilver RM, Branch DW. Placenta Accreta Spectrum. N Engl J Med. 2018 Apr 19;378(16):1529-1536. doi: 10.1056/NEJMcp1709324. No abstract available.
PMID: 29669225BACKGROUNDDahlke JD, Mendez-Figueroa H, Maggio L, Hauspurg AK, Sperling JD, Chauhan SP, Rouse DJ. Prevention and management of postpartum hemorrhage: a comparison of 4 national guidelines. Am J Obstet Gynecol. 2015 Jul;213(1):76.e1-76.e10. doi: 10.1016/j.ajog.2015.02.023. Epub 2015 Feb 28.
PMID: 25731692BACKGROUNDWeiniger CF, Elram T, Ginosar Y, Mankuta D, Weissman C, Ezra Y. Anaesthetic management of placenta accreta: use of a pre-operative high and low suspicion classification. Anaesthesia. 2005 Nov;60(11):1079-84. doi: 10.1111/j.1365-2044.2005.04369.x.
PMID: 16229692BACKGROUNDSnyder CW, Weinberg JA, McGwin G Jr, Melton SM, George RL, Reiff DA, Cross JM, Hubbard-Brown J, Rue LW 3rd, Kerby JD. The relationship of blood product ratio to mortality: survival benefit or survival bias? J Trauma. 2009 Feb;66(2):358-62; discussion 362-4. doi: 10.1097/TA.0b013e318196c3ac.
PMID: 19204508BACKGROUNDPacheco LD, Saade GR, Costantine MM, Clark SL, Hankins GD. An update on the use of massive transfusion protocols in obstetrics. Am J Obstet Gynecol. 2016 Mar;214(3):340-4. doi: 10.1016/j.ajog.2015.08.068. Epub 2015 Sep 5.
PMID: 26348379BACKGROUNDFinberg HJ, Williams JW. Placenta accreta: prospective sonographic diagnosis in patients with placenta previa and prior cesarean section. J Ultrasound Med. 1992 Jul;11(7):333-43. doi: 10.7863/jum.1992.11.7.333.
PMID: 1522623BACKGROUNDFarquhar CM, Li Z, Lensen S, McLintock C, Pollock W, Peek MJ, Ellwood D, Knight M, Homer CS, Vaughan G, Wang A, Sullivan E. Incidence, risk factors and perinatal outcomes for placenta accreta in Australia and New Zealand: a case-control study. BMJ Open. 2017 Oct 5;7(10):e017713. doi: 10.1136/bmjopen-2017-017713.
PMID: 28982832BACKGROUNDGibbins KJ, Einerson BD, Varner MW, Silver RM. Placenta previa and maternal hemorrhagic morbidity. J Matern Fetal Neonatal Med. 2018 Feb;31(4):494-499. doi: 10.1080/14767058.2017.1289163. Epub 2017 Feb 21.
PMID: 28140723BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 11, 2022
First Posted
June 3, 2022
Study Start
September 1, 2022
Primary Completion
September 1, 2023
Study Completion
October 1, 2023
Last Updated
July 15, 2022
Record last verified: 2022-05