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

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.

Study Overview

• Status: Recruiting
• Conditions: Placenta Previa
• Intervention / Treatment: Diagnostic test: Ultrasonographic parameters

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.

• Study Type: Observational
• Enrollment (Estimated): 68

Contacts and Locations

• Study Contact: Name: Maya Abdelrazek, MD; Phone Number: 01222393983; Email: dr_maya89@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Faculty of Medicine, Ain Shams University
    • Contact: Ayman Abulnor, MD; Phone Number: 01223414990; Email: aymanabulnour@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Asymptomatic pregnant women diagnosed with placenta previa between 28 to 37 weeks' gestation.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maternal bleeding rate	number of attacks of antepartum hemorrhage	till delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood transfusion	number of PRBCs	till delivery 36 to 37 weeks
Emergency Cesarean section	severe antepartum hemorrhage requiring delivery	till delivery 36 to 37 weeks
Premature delivery	before the planned delivery date (before 37 weeks' gestation)	37 week's gestation
Need for cesarean hysterectomy	cesarean hysterectomy due to bleeding or placenta accreta spectrum	during cesarean section
Postpartum hemorrhage	severity of attacks and required further management or blood transfusion	Within 2 hours of delivery

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemorrhage; Placenta Previa
• Other Study ID Numbers: MD 172 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No