Pulmonary Artery Doppler and Neonatal Outcome in Placenta Accreta Spectrum Patients

September 3, 2022 updated by: Noran Amin, Cairo University

Correlation Between Pulmonary Artery Doppler And Other Ultrasonographic Markers With Neonatal Outcome In Placenta Accreta Spectrum Patients

To correlate ultrasonographic markers of fetal lung maturity including Pulmonary artery Doppler indices in the late preterm and early term in placenta accreta spectrum patients with neonatal outcome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The increasing rates of cesarean section has led to several fold increase in the incidence of placenta accreta spectrum in the last three or four decades.

Placenta accreta spectrum (PAS) disorders is the term used to describe a variety of pregnancy complications resulting from abnormal placental implantation that is accompanied by deficiency of the uterine wall.

Placenta accreta spectrum includes placenta accreta, placenta increta, placenta percreta.

Placenta accreta spectrum is one of the devastating obstetric complications owing to massive hemorrhage encountered during manual removal of the placenta to preserve the uterus or even the need for peripartum hysterectomy, need for massive blood transfusion, maternal intensive care admission and maternal mortality.

Complications related to blood loss are lower in elective compared to emergency deliveries. This has led to the scheduling of surgical interventions with planned late preterm (35-36 weeks) or early term (37 weeks) delivery as a mechanism to avoid the need for emergency surgery. According to the RCOG guidelines, planned delivery at 35 0/7- 36 0/7 weeks of gestation provides the best chance between fetal maturity and the risk of unscheduled delivery while ACOG recommends 34 0/7- 35 6/7.

Early attempts have been made to predict fetal maturity on the basis antenatal sonographic parameters including lung characteristics, bowel pattern, placental grading (which cannot be relied upon in patients with placenta accreta spectrum), and the presence or absence of intraamniotic particles (vernix caseosa).

Additionally, the epiphyseal ossification centers appear and enlarge at variable rates but in a predictable sequence: the distal femoral epiphysis (DFE) appears prior to the proximal tibial epiphysis (PTE), which precedes the appearance of the proximal humeral epiphysis (PHE). The PTE grows more rapidly than does the DFE so that, as gestation progresses, the size of the PTE approaches that of the DFE.

More recently, fetal pulmonary artery Doppler has been used to predict neonatal RDS. It was found that an elevated acceleration-to-ejection time ratio was significantly associated with neonatal RDS. However such indices cannot be generalized in all cases, especially those with placenta accreta spectrum who have excessive placental shunting affecting fetoplacental circulation resistance.

To the best of our knowledge, no available studies have correlated signs of maturity of the fetus detected by ultrasound with neonatal outcomes in the late preterm and early term in such patients. Presence of such signs of maturity can aid the obstetrician to choose the most appropriate timing for termination especially in low income countries who have limited access to NICUs.

Being cost effective and non invasive, ultrasonography is used as a routine obstetric scanning tool. This study will help determine the utility of ultrasound in assessing the fetal lung maturity in such patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

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
      • Giza, Egypt
        • Kasralainy Cairo University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with placenta accreta spectrum with singleton pregnancy undergoing cesarean delivery in Kasr Alainy hospital.

Description

Inclusion Criteria:

  • Age: 18-42 years old
  • Patients who will be diagnosed with placenta accreta spectrum preoperatively according to (ACOG 2018), (Jauniaux et al., 2018 a), (Jauniaux et al., 2018 b)
  • Those who will undergo elective or emergency cesarean.
  • With gestational age: 34 0/7 - 38 6/7 weeks
  • Under the effect of general anesthesia

Exclusion Criteria:

  • Multifetal pregnancy
  • Intrauterine fetal death
  • Intrauterine growth restriction (IUGR) which is defined as a rate of fetal growth that is less than normal for the growth potential of that specific infant
  • Diabetes with pregnancy either gestational or overt which is defined as any degree of glucose intolerance with an onset or first recognition during pregnancy
  • Pregnancy induced hypertension defined as either systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg. It is classified as one of four conditions: preexisting hypertension, gestational hypertension, preeclampsia, preexisting hypertension with superimposed preeclampsia
  • Premature rupture of membranes
  • BMI above 40 due to technical difficulties to obtain accurate measures
  • Narcotic usage during anesthesia before fetal delivery
  • Major congenital fetal anomalies whether diagnosed before or after delivery
  • Maternal fever more than 37.4 degree
  • Emergent cases presenting with fetal distress (bradycardia will be defined as fetal heart rate < 110 beat per minute)
  • Patients who have not completed the course of antenatal corticosteroids according to (RCOG 2010).
  • Intraoperative spontaneous separation of the placenta

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceleration time to ejection time (At/Et) ratio of fetal pulmonary artery Doppler in neonates with good and poor outcome.
Time Frame: Baseline
(At/Et) ratio will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The pulsatility index (PI) of the fetal pulmonary artery Doppler in neonates with good and poor outcome.
Time Frame: Baseline
The PI will be measured in the fetal main pulmonary artery and will be correlated with the neonatal outcome
Baseline
The resistance index (RI) of the fetal pulmonary artery Doppler in neonates with good and poor outcome
Time Frame: Baseline
RI will be measured in the fetal main pulmonary artery and will be correlated with the neonatal outcome
Baseline
The systolic to diastolic ratio (S/D) of the fetal pulmonary artery Doppler in neonates with good and poor outcome
Time Frame: Baseline
S/D will be measured in the fetal main pulmonary artery and will be correlated with the neonatal outcome
Baseline
The peak systolic velocity (PSV) of the fetal pulmonary artery Doppler in neonates with good and poor outcome
Time Frame: Baseline
PSV will be measured in the fetal main pulmonary artery and will be correlated with the neonatal outcome
Baseline
Optimal timing of delivery in PAS for best neonatal outcome
Time Frame: baseline
according to the neonatal outcome, the best timing for delivery will be determined
baseline
Optimal timing of delivery in PAS for best maternal outcome
Time Frame: baseline
according to the maternal mortality and morbidity rate, the best timing for delivery will be obtained
baseline
percent of women who will undergo cesarean hysterectomy versus conservative management
Time Frame: baseline
surgical management options; cesarean hysterectomy and conservative management will be recorded
baseline
The need for blood transfusion
Time Frame: baseline
The need for replacement by blood or blood products will be recorded
baseline
Maternal morbidity in the form of organ injury will be recorded
Time Frame: baseline
Organ injury will be recorded
baseline
The need for peripartum hysterectomy will be recorded
Time Frame: Baseline
The need for peripartum hysterectomy either in cases of abnormally invasive placenta or in cases of abnormally adherent placenta in which the placenta separated but with uncontrollable bleeding
Baseline
Maternal mortality rate
Time Frame: Baseline
Rate of maternal mortality will be recorded
Baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ahmed H El Sawaf, MD, Cairo University
  • Study Chair: Tarek M El Husseiny, MD, Cairo University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAS disorders

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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