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Status unknownNCT05403203Updated Jul 15, 2022

Prediction of Bleeding in Placenta Previa

An observational study in Placenta Previa Bleeding, sponsored by Assiut University. Status unknown. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-07-15.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 40 Years
Sex
Female
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Study 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 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

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Conditions studied

  • Placenta Previa Bleeding

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03

In context

Placenta Previa

80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 32 observational studies indexed under Placenta Previa.

Browse Placenta Previa studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

women with placenta previa or accreta after 32 weeks

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.

Inclusion criteria

  • women with placenta previa after 32 weeks
  • women with placenta accreta after 32 weeks

Exclusion criteria

Exclusion Criteria:

  • abruption placenta
  • unavilable or limited avilability of blood group
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

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

    Time frame: baseline

Secondary outcomes

  1. 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)

    Time frame: baseline

  2. The effect on mortality of pregnant women .

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

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 26244528 ↗
  • Rouse 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. Erratum In: Obstet Gynecol. 2006 Dec;108(6):1556. PubMed 17012451 ↗
  • Silver 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 29669225 ↗
  • Dahlke 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 25731692 ↗
  • Weiniger 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 16229692 ↗
  • Snyder 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 19204508 ↗
  • Pacheco 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. Erratum In: Am J Obstet Gynecol. 2017 Jan;216(1):76. doi: 10.1016/j.ajog.2016.09.102. PubMed 26348379 ↗
  • Finberg 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 1522623 ↗
  • Farquhar 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 28982832 ↗
  • Gibbins 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05403203
Lead sponsor
Assiut University
Responsible party
Youssef khalaf makary (Principal investigator, Assiut University) — Principal investigator
First posted
Jun 3, 2022
Start date
Sep 1, 2022 (estimated)
Primary completion
Sep 1, 2023 (estimated)
Completion
Oct 2023 (estimated)
Last update
Jul 15, 2022

Study contacts

youssef khalaf, master
Contact
youssefkhalaf99@gmail.com
01018061561
Mohamed Mahmoud Fahmy Fathalla, prof
Contact
mfathalla@aun.edu.eg
01154320395

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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