Diagnostic Accuracy of Placental Thickness in Lower Uterine Segment Measured By Ultrasound in Prediction of Placenta Accreta Spectrum in Patients With Placenta Previa. A Diagnostic Test Accuracy Study

November 19, 2022 updated by: Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital

Current prenatal diagnosis of placenta accrete spectrum disorders relies on subjective individual interpretations of visual sonographic findings on grayscale and color Doppler imaging. When blinded to clinical data, there is significant interobserver variability in the diagnosis of invasive placentation.

This study will evaluate placental thickness among pregnant women with placenta previa and determine if increased placenta thickness correlates with the risk for placenta accreta spectrum (PAS) disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Placenta accreta spectrum is one of the most dangerous conditions associated with pregnancy, because hemorrhage may result in multisystem organ failure, disseminated intravascular coagulation, need for admission to an intensive care unit, hysterectomy, and even death. The reported incidence of placenta accrete spectrum disorder has increased over time and is currently between 1 in 533 to 1 in 300 pregnancies. Prior cesarean delivery and especially multiple cesarean deliveries are major risk factors. The spectrum includes placenta accreta (attachment of the placenta to myometrium without intervening decidua), placenta increta (invasion of the trophoblast into the myometrium), and placenta percreta (invasion through the myometrium, serosa, and into surrounding structures). PAS is linked to placenta previa, and there is a lot of overlap in imaging findings between the two processes. PAS problems affect approximately 11% of people with placenta previa. Differentiating between placenta previa with and without PAS problems is crucial in clinical practice. A finding of placenta previa together with a history of cesarean delivery has long been an indication for counseling patients on their risk of PAS in a current pregnancy, as the risk for placenta accreta in the presence of placenta previa increases with each subsequent cesarean delivery. Aside from cesarean deliveries and placenta previa, other risk factors have been identified for PAS, including past uterine surgeries, in vitro fertilization (IVF), multiparity, maternal age, and even female sex of the infant. Prenatal diagnosis of AIP has been shown to reduce maternal morbidity associated with this condition, most likely due to the opportunity to plan management in advance. Ultrasound is the primary investigation for prenatal diagnosis of morbidly adherent placenta, and the diagnostic accuracy is good both in retrospective, as well as prospective case series. Placental localization with transabdominal sonography (TAS) has been a standard practice for a long time. Despite its availability and noninvasive nature, accuracy of TAS may be limited by many factors, such as the posterior implantation of placenta, being obscured by the fetal head, an under-filled or over-distended bladder, and presence of blood clots, fibroids, uterine contractions, and obesity. These limitations are overcome by transvaginal sonography (TVS), which provides a better resolution by using a higher frequency transducer, shorter distance from the transducer to the internal os, and is not affected by the over- or under-filling of the bladder. Although ultrasonography's sensitivity and specificity for detecting accreta have been reported to be excellent, ranging from 80 to 90%, there was considerable difference among "experts" in predicting whether PAS was present. With placental implantation into the cesarean section scar, the center of the placental disc would be in the vicinity of the lower uterine scar. If placental implantation was near the scar but not in it, only the thinner placental margin might encroach into the lower uterine segment. The investigators therefore hypothesized that the placenta is thicker with AIP in women with a low-lying placenta or placenta previa. So, the investigators hypothesize that placental thickness will be directly related to placental invasion in cases of placenta accrete spectrum.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ainshams University maternity hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with placenta Previa attending outpatient obstetric clinic at Ain Shams University Maternity Hospital

Description

Inclusion Criteria:

  • Pregnant women with ultrasound diagnosis of placenta previa or low lying placenta
  • Gestational age above 26 weeks
  • singleton pregnancy
  • fetal life positive
  • Past history of cesarean section regardless of the number

Exclusion Criteria:

  • Hemodynamically unstable women.
  • Patients with pregestational or gestational DM.
  • Multiple gestation.
  • Medical disorders which can lead to uteroplacental insufficiency (preeclampsia - SLE - antiphospholipid antibody syndrome).
  • Any condition which can lead to enlarged placenta such as fetal hydrops

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Placental thickness threshold
Time Frame: after 26 weeks of pregnancy
Threshold of placental thickness which can be used as cutoff level with appropriate sensitivity and specificity so it can be used as a screening test for such morbid condition.
after 26 weeks of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Study Director: Ahmed M Mamdouh, MD, Ainshams University maternity hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 19, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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