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

Recruiting

• Conditions: Placenta Previa

• Registration Number: NCT05802251
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
maternal bleeding rate	till delivery	number of attacks of antepartum hemorrhage

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt