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Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study

Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05802251
Enrollment
68
Registered
2023-04-06
Start date
2022-06-01
Completion date
2024-08-31
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Previa

Brief summary

The aim of this study is to evaluate the effectiveness of ultrasonographic parameters (cervical length, placental thickness and distance placental edge from internal os of the cervix) in predicting the risk of antepartum hemorrhage and emergency cesarean delivery in asymptomatic women with placenta previa.

Detailed description

The incidence of placenta previa is 3-5 per 1000 pregnancies worldwide and is still rising because of increased maternal age, parity, cesarean section rates, assisted reproductive technology, maternal smoking with the widespread use of transvaginal ultrasound. antepartum hemorrhage is an important cause of maternal and neonatal morbidity and mortality in pregnant women with placenta previa. However, the epidemiological characteristics are not completely understood. this study aims at evaluating the sonographic findings in asymptomatic women with placenta previa as cervical length, placenta thickness and distance from cervix to placental edge to recommend management for in-patients versus out-patient antenatal care and early planned hospital admission and delivery for women at high risk of antepartum hemorrhage and preterm cesarean section and hysterectomy for life threatening antepartum hemorrhage.

Interventions

DIAGNOSTIC_TESTUltrasonographic parameters

cervical length. placental thickness. distance placental edge from internal os of the cervix

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Asymptomatic women diagnosed with placenta previa according to RCOG (GTG No. 27a, 2018): placenta lies directly over the internal os for pregnancies more than 16 weeks' gestation on transabdominal or transvaginal scanning. * Gestational age between 28 till 37 weeks' gestation (as delivery should be considered between 36 and 37 weeks of gestation for women presenting with uncomplicated placenta previa)

Exclusion criteria

* Multiple pregnancies. * Threatened preterm labor or preterm rupture of membranes. * History of bleeding in the current pregnancy. * Polyhydraminos (AFI \> 25 cm). * History of cervical surgery (cone biopsy). * Presence of cervical cerclage. * Maternal use of vaginla progesterone. * History of maternal disease (hypertensive, DM, Cardiac). * Fetal malformation or growth restriction

Design outcomes

Primary

MeasureTime frameDescription
maternal bleeding ratetill deliverynumber of attacks of antepartum hemorrhage

Secondary

MeasureTime frameDescription
Blood transfusiontill delivery 36 to 37 weeksnumber of PRBCs
Emergency Cesarean sectiontill delivery 36 to 37 weekssevere antepartum hemorrhage requiring delivery
Premature delivery37 week's gestationbefore the planned delivery date (before 37 weeks' gestation)
Need for cesarean hysterectomyduring cesarean sectioncesarean hysterectomy due to bleeding or placenta accreta spectrum
Postpartum hemorrhageWithin 2 hours of deliveryseverity of attacks and required further management or blood transfusion

Countries

Egypt

Contacts

Primary ContactMaya Abdelrazek, MD
dr_maya89@med.asu.edu.eg01222393983

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026