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

NCT05802251 | Recruiting

• 1 other identifier: MD 172 2022
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (1)

• maternal bleeding rate

  number of attacks of antepartum hemorrhage

  till delivery

Secondary Outcomes (5)

• Blood transfusion

  till delivery 36 to 37 weeks

• Emergency Cesarean section

  till delivery 36 to 37 weeks

• Premature delivery

  37 week's gestation

• Need for cesarean hysterectomy

  during cesarean section

• Postpartum hemorrhage

  Within 2 hours of delivery

Interventions

Ultrasonographic parameters DIAGNOSTIC_TEST

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

Eligibility Criteria

• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Central Study Contacts

Maya Abdelrazek, MD

CONTACT

01222393983; dr_maya89@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: June 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

EG (1)