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The Placental Thickness and Pregnancy Outcomes in Placenta Previa Women

NCT ID: NCT06717997

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Placenta Accreta

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Normal placental thickness women

Group Type OTHER

ultrasound

Intervention Type 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

Group Type OTHER

ultrasound

Intervention Type 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).

Interventions

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ultrasound

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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Women with severe bleeding necessitate immediate delivery.
2. Women with confirmed fetal malformation.
3. If associated with abruptio placentae.
4. Women who will refuse to participate.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Khairy Ali

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Women Health Hospital - Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PAS-US

Identifier Type: -

Identifier Source: org_study_id