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Clinical Trials/NCT05802251
NCT05802251
Recruiting
Not Applicable

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

Ain Shams University1 site in 1 country68 target enrollmentJune 1, 2022
ConditionsPlacenta Previa

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Placenta Previa
Sponsor
Ain Shams University
Enrollment
68
Locations
1
Primary Endpoint
maternal bleeding rate
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
August 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maya Abdelrazek

Lecturer

Ain Shams University

Eligibility Criteria

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

Outcomes

Primary Outcomes

maternal bleeding rate

Time Frame: till delivery

number of attacks of antepartum hemorrhage

Secondary Outcomes

  • Emergency Cesarean section(till delivery 36 to 37 weeks)
  • Blood transfusion(till delivery 36 to 37 weeks)
  • Premature delivery(37 week's gestation)
  • Postpartum hemorrhage(Within 2 hours of delivery)
  • Need for cesarean hysterectomy(during cesarean section)

Study Sites (1)

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