The Placental Thickness and Pregnancy Outcomes in Placenta Previa Women

NCT06717997 | Not Yet Recruiting

• 1 other identifier: PAS-US
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Placenta previa is the placenta overlying the cervical os. Placenta previa is about 1 in 200 pregnancies. The risk factors are the increasing rate of cesarean section and previous uterine surgery. Placenta previa is associated with many adverse complications; the most serious one is related to maternal hemorrhage. The diagnosis of placenta previa is done by trans-abdominal and trans-vaginal ultrasonography, which can document the placental edge's relationship to the internal os. Placenta accreta spectrum disorder is defined when trophoblastic invades the myometrium. The Placenta accreta spectrum can be categorized as: placenta accreta, placenta increta, and placenta percreta. The clinical utility of placental thickness is an area of ongoing research in placenta previa. Prior studies have demonstrated an association between mid-trimester placental thickness and placenta accreta spectrum. Despite the presence of many studies in characterizing placental thickness, most studies have focused primarily on the placental accreta spectrum lacking information about other fetal and maternal complications. Symptomatic (bleeding) placenta previa is associated with increased maternal and neonatal morbidity and mortality. In addition; the mechanism that involves bleeding is unclear. It is usually related to uterine contractions, cervical effacement, and dilation leading to separation of the placenta from the underlying decidua.

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

• number of women with placenta accreta

  3 weeks

Study Arms (2)

Normal placental thickness women

OTHER

Other: ultrasound

High placental thickness women

OTHER

Other: ultrasound

Interventions

ultrasound OTHER

The placenta thickness will be performed on transabdominal images obtained in a longitudinal plane. Three measurements will be performed at the thickest portion of the placenta. The average of these three measurements was used for statistical analysis. The cohorts will be classified into 1) thick placenta (\>4 cm) and average placenta (2-4 cm).

High placental thickness women; Normal placental thickness women

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women from 32-34 weeks.
• Pregnant women with singleton pregnancy.
• Women with placenta previa.
• Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
• Women without any medical disorders.
• Women should be living in a nearby area to make follow-up and early transportation is reasonably possible.

You may not qualify if:

• Women with severe bleeding necessitate immediate delivery.
• Women with confirmed fetal malformation.
• If associated with abruptio placentae.
• Women who will refuse to participate.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 5, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

EG (1)