Pulmonary Artery Doppler And Neonatal Outcome In Hypertensive Disorders Of Pregnancy

April 3, 2023 updated by: Noran Amin, Cairo University

Correlation Between Pulmonary Artery Doppler And Neonatal Outcome In Hypertensive Disorders Of Pregnancy

To correlate fetal Pulmonary artery Doppler parameters with neonatal outcome in patients diagnosed with hypertensive disorders of pregnancy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hypertensive disorders include gestational hypertension, preeclampsia, chronic hypertension, preeclampsia superimposed on chronic hypertension. They complicate up to 10% of pregnancies. As a group they are one member of the deadly triad, along with hemorrhage and infection, that contributes greatly to maternal morbidity.

Preeclampsia, either alone or superimposed on chronic hypertension, is the most dangerous. Most hypertension related deaths are preventable. Also, nonsevere preeclampsia may progress rapidly to severe disease causing headache or visual disturbance that precede eclampsia. They also cause epigastic or right upper quadrant pain and elevated hepatic transaminases that frequently accompany hepatocellular necrosis, ischemia and edema, thrombocytopenia that represents platelet activation and aggregation, microangiopathic hemolysis, renal involvement and placental abruption. On the long term, preeclampsia is also associated with adverse health problems including chronic hypertension, ischemic heart disease, atherosclerosis, cardiomyopathy, peripheral vascular disease, type 2 diabetes, dyslipidemia, obesity and metabolic syndrome.

Termination of pregnancy is the only known cure for preeclampsia. Moreover, expectant management of preterm severe preeclampsia leads to disastrous results as increase in perinatal mortality rate, placental abruption, eclampsia, renal failure, hypertensive encephalopathy, intracranial hemorrhage or even rupture in hepatic hematoma.

Early attempts have been made to predict fetal maturity on the basis antenatal ultrasonographic parameters including lung characteristics, bowel pattern, placental grading, the presence or absence of intraamniotic particles (vernix caseosa) and the epiphyseal ossification centers appearance and enlargement.

More recently, fetal pulmonary artery Doppler has been used to predict neonatal respiratory rate (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 hypertensive disorders of pregnancy who have abnormal trophoblastic invasion of uterine vessels affecting fetoplacental circulation resistance.

To the best of our knowledge, no available studies have correlated fetal pulmonary artery Doppler indices with neonatal outcomes in patients with hypertensive disorders of pregnancy. 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 neonatal intensive care units. Being cost effective and non invasive ultrasonography is used as a routine obstetrics scanning tool. This study will help determine the utility of ultrasound and Doppler in assessing the fetal lung maturity in such patients.

Study Type

Observational

Enrollment (Anticipated)

72

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Kasralainy Cairo University
        • Contact:

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

18 years to 42 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant patients diagnosed with hypertensive disorders undergoing elective or emergency termination of pregnancy in Kasr Alainy hospital.

Description

Inclusion Criteria:

  • Age: 18-42 years old
  • Patients who will be diagnosed with hypertensive disorders of pregnancy preoperatively according to (ACOG 2020)
  • Those who will undergo elective or emergency termination of pregnancy whether by vaginal or cesarean delivery .
  • Primi or multigravida
  • With gestational age: 28 0/7 - 37 6/7 weeks

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
  • Placental abruption whether diagnosed before or during delivery.
  • Absent or reversed umbilical artery end diastolic flow.
  • Diabetes with pregnancy either gestational or overt which is defined as any degree of glucose intolerance with an onset or first recognition during pregnancy
  • Premature or prelabor rupture of membranes
  • BMI above 40 due to technical difficulties to obtain accurate measures
  • 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)
  • Patient receiving general anesthesia if termination was by cesarean delivery
  • Patients receiving narcotics 4 hours before delivery
  • Patients with unreliable dates or no crown rump length at first trimester.

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

Outcome Measure
Measure Description
Time Frame
Acceleration time to ejection time ratio (At/Et) of fetal pulmonary artery Doppler in neonates needing respiratory support
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

Outcome Measure
Measure Description
Time Frame
The pulsatility index (PI) of fetal pulmonary artery Doppler in neonates needing respiratory support
Time Frame: Baseline
The PI will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome
Baseline
The resistance index (RI) of fetal pulmonary artery Doppler in neonates needing respiratory support
Time Frame: baseline
The RI will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome
baseline
The systolic to diastolic ratio (S/D) of fetal pulmonary artery Doppler in neonates needing respiratory support
Time Frame: baseline
The S/D ratio will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome
baseline
The peak systolic velocity (PSV) of fetal pulmonary artery Doppler in neonates needing respiratory support
Time Frame: baseline
The PSV will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome
baseline

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Ahmed H El Sawaf, MD, Cairo University
  • Study Chair: Ahmed M Salah, 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)

April 3, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

March 19, 2023

First Submitted That Met QC Criteria

March 19, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pregnancy induced hypertension

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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