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

Placenta Previa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802251
• Other study ID #: MD 172 2022
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: Ain Shams University
• Contact: Maya Abdelrazek, MD
• Phone: 01222393983
• Email: dr_maya89[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Placenta Previa

Intervention

Diagnostic Test:
• Ultrasonographic parameters
cervical length. placental thickness. distance placental edge from internal os of the cervix

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

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