Pulmonary Artery Doppler And Neonatal Outcome In Hypertensive Disorders Of Pregnancy

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 42 Years
Gender Female
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05793125
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Cairo University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ahmed H El Sawaf, MDAhmed M Salah, MD
Principal Investigator Affiliation Cairo UniversityCairo University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Egypt
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hypertension in Pregnancy
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Kasralainy Cairo University, Giza, Egypt

Status

Recruiting

Address

Kasralainy Cairo University

Giza, ,

Site Contact

Assistant lecturer

mennaamin94@gmail.com

01221574378

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

Submit Feedback

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation in a clinical trial or study.