Placenta Previa BleedingNCT05403203
Prediction of Bleeding in Placenta Previa
An observational study of Placenta Previa Bleeding, run by Assiut University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Placenta Previa Bleeding
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: women with placenta previa or accreta after 32 weeks
Who may be able to join
- women with placenta previa after 32 weeks
- women with placenta accreta after 32 weeks
Who cannot join
- abruption placenta
- unavilable or limited avilability of blood group
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prediction of Need of Blood Transfusion > 4 Units of Packed RBCS in Cases Diagnosed With Placenta Previa During Cesarean Section .
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 .
Read the detailed description
Womenwith placenta previa after 32 weeks will be assessed for participation if they are eligible an adequate data will be taken :
- Clinical factors : including maternal age, abortion history, cesarean section history, gestational age at delivery, whether the operation will be carried out as an emergency surgery, and whether bleeding has started before the operation, will evaluated. The number of abortion history will be counted only if a dilatation and curettage was performed. Preoperative hemoglobin and hematocrit values will be checked. The amount of PRBCs transfused during operation will be measured.
-Ultrasonographic factor: Adiagnosis of placenta previa was made when the placenta covered the internal orifice of the cervix after 32 weeks' gestation. We will check for the presence of a hypoechoic area between the myometrium and the placenta. The vascularity of the placenta will be classified as normal or hypervascular on color Doppler imaging. We will examine the location of placenta ( anterior . posterior. Anterior with lateral deviation. Posterior with lateral deviation) and presence ofintraplacental lacunae (an irregular area of low echogenicity larger than 1 cm × 1 cm in the placental parenchyma)
- Intraoperative factor:
Assess surgeon years of experience Management plan hemostatic sutures other conservative management hysterectomy (primary or secondary) Assessment of amount of blood taken in 24 h from operation
- Conditions
- Placenta Previa Bleeding
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (2)
The effect on morbidity of pregnant women .
Morbidities were defined as organ system dysfunctions related to severe obstetric hemorrhage and included: acute respiratory distress syndrome (impairment of respiratory function needing ventilation, oxygen supplementation, or decreased physical activity level as compared to pre-pregnancy), cerebral impairment (seizures, unconsciousness, or cognitive/motor loss), renal failure (creatinine > 1.5 mg/dL or increased >1.0 mg/dL above baseline, oliguria; <120 mL output in 4-hour intervals), and heart failure (impairment of cardiac function according to New York Heart Disease Classification)
Measured: baseline
The effect on mortality of pregnant women .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Placenta Previa BleedingStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youssef khalaf makary, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403203
- Sponsor's protocol ID
- bleeding in placenta previa
- Status last verified
- May 2022
- First submitted
- 11 May 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-668. doi: 10.1097/AOG.0000000000001005.
PubMed 26244528Rouse 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.
PubMed 17012451Silver RM, Branch DW. Placenta Accreta Spectrum. N Engl J Med. 2018 Apr 19;378(16):1529-1536. doi: 10.1056/NEJMcp1709324. No abstract available.
PubMed 29669225Dahlke 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.
PubMed 25731692Weiniger 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.
PubMed 16229692Snyder 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.
PubMed 19204508Pacheco 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.
PubMed 26348379Finberg 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.
PubMed 1522623Farquhar 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.
PubMed 28982832Gibbins 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.
PubMed 28140723
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Need of Blood Transfusion > 4 Units of Packed RBCS in Cases Diagnosed With Placenta Previa During Cesarean Section .
- ClinicalTrials.gov ID
- NCT05403203
- Acronym / sponsor ID
- bleeding in placenta previa
- Conditions
- Placenta Previa Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
Womenwith placenta previa after 32 weeks will be assessed for participation if they are eligible an adequate data will be taken :
- Clinical factors : including maternal age, abortion history, cesarean section history, gestational age at delivery, whether the operation will be carried out as an emergency surgery, and whether bleeding has started before the operation, will evaluated. The number of abortion history will be counted only if a dilatation and curettage was performed. Preoperative hemoglobin and hematocrit values will be checked. The amount of PRBCs transfused during operation will be measured.
-Ultrasonographic factor: Adiagnosis of placenta previa was made when the placenta covered the internal orifice of the cervix after 32 weeks' gestation. We will check for the presence of a hypoechoic area between the myometrium and the placenta. The vascularity of the placenta will be classified as normal or hypervascular on color Doppler imaging. We will examine the location of placenta ( anterior . posterior. Anterior with lateral deviation. Posterior with lateral deviation) and presence ofintraplacental lacunae (an irregular area of low echogenicity larger than 1 cm × 1 cm in the placental parenchyma)
- Intraoperative factor:
Assess surgeon years of experience Management plan hemostatic sutures other conservative management hysterectomy (primary or secondary) Assessment of amount of blood taken in 24 h from operation
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- women with placenta previa or accreta after 32 weeks
Key inclusion criteria (2 listed)
- women with placenta previa after 32 weeks
- women with placenta accreta after 32 weeks
Key exclusion criteria (2 listed)
- abruption placenta
- unavilable or limited avilability of blood group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ability of a score of the study to predict the need for blood transfusion > 4 units of packed RBCs
Time frame: baseline
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
2 secondary outcomes
The effect on morbidity of pregnant women .
Time frame: baseline
The effect on mortality of pregnant women .
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Background: PubMed 26244528Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-668. doi: 10.1097/AOG.0000000000001005.
- Background: PubMed 17012451Rouse 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.
- Background: PubMed 29669225Silver RM, Branch DW. Placenta Accreta Spectrum. N Engl J Med. 2018 Apr 19;378(16):1529-1536. doi: 10.1056/NEJMcp1709324. No abstract available.
- Background: PubMed 25731692Dahlke 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.
- Background: PubMed 16229692Weiniger 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.
- Background: PubMed 19204508Snyder 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.
- Background: PubMed 26348379Pacheco 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.
- Background: PubMed 1522623Finberg 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.
- Background: PubMed 28982832Farquhar 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.
- Background: PubMed 28140723Gibbins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Previa Bleeding, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact youssef khalaf, master (01018061561, youssefkhalaf99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of a score of the study to predict the need for blood transfusion > 4 units of packed RBCs (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05403203, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.