Pulmonary Artery Doppler And Neonatal Outcome In Hypertensive Disorders Of Pregnancy

NCT05793125 | Completed

• 1 other identifier: Pregnancy induced hypertension
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Acceleration time to ejection time ratio (At/Et) of fetal pulmonary artery Doppler in neonates needing respiratory support

  (At/Et) ratio will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome

  Baseline

Secondary Outcomes (4)

• The pulsatility index (PI) of fetal pulmonary artery Doppler in neonates needing respiratory support

  Baseline

• The resistance index (RI) of fetal pulmonary artery Doppler in neonates needing respiratory support

  baseline

• The systolic to diastolic ratio (S/D) of fetal pulmonary artery Doppler in neonates needing respiratory support

  baseline

• The peak systolic velocity (PSV) of fetal pulmonary artery Doppler in neonates needing respiratory support

  baseline

Interventions

Ultrasonography DEVICE

A full obstetrics ultrasound scan will be performed within 24 hours before delivery to document fetal biometry, estimated fetal weight and correlate it to fetal growth charts to exclude IUGR, amniotic fluid index and umbilical artery Doppler studies. Fetal echocardiography will be done.Pulmonary artery Doppler flow waveforms, including pulsatility index, resistance index, systolic-to-diastolic ratio, peak systolic velocity, and acceleration time to ejection time (At/Et) ratio will be measured in the main pulmonary artery.

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasralainy Cairo University

Giza, Egypt

Location

Related Publications (10)

• Judy AE, McCain CL, Lawton ES, Morton CH, Main EK, Druzin ML. Systolic Hypertension, Preeclampsia-Related Mortality, and Stroke in California. Obstet Gynecol. 2019 Jun;133(6):1151-1159. doi: 10.1097/AOG.0000000000003290.

  PMID: 31135728 BACKGROUND

• Buchanan TA, Xiang AH. Gestational diabetes mellitus. J Clin Invest. 2005 Mar;115(3):485-91. doi: 10.1172/JCI24531.

  PMID: 15765129 BACKGROUND

• Churchill D, Duley L, Thornton JG, Moussa M, Ali HS, Walker KF. Interventionist versus expectant care for severe pre-eclampsia between 24 and 34 weeks' gestation. Cochrane Database Syst Rev. 2018 Oct 5;10(10):CD003106. doi: 10.1002/14651858.CD003106.pub3.

  PMID: 30289565 BACKGROUND

• Hornberger LK, Sahn DJ. Rhythm abnormalities of the fetus. Heart. 2007 Oct;93(10):1294-300. doi: 10.1136/hrt.2005.069369. No abstract available.

  PMID: 17890709 BACKGROUND

• Katsuragi S, Tanaka H, Hasegawa J, Nakamura M, Kanayama N, Nakata M, Murakoshi T, Yoshimatsu J, Osato K, Tanaka K, Sekizawa A, Ishiwata I, Ikeda T; Maternal Death Exploratory Committee in Japan and Japan Association of Obstetricians and Gynecologists. Analysis of preventability of hypertensive disorder in pregnancy-related maternal death using the nationwide registration system of maternal deaths in Japan. J Matern Fetal Neonatal Med. 2019 Oct;32(20):3420-3426. doi: 10.1080/14767058.2018.1465549. Epub 2018 Apr 26.

  PMID: 29699420 BACKGROUND

• Mahony BS, Bowie JD, Killam AP, Kay HH, Cooper C. Epiphyseal ossification centers in the assessment of fetal maturity: sonographic correlation with the amniocentesis lung profile. Radiology. 1986 May;159(2):521-4. doi: 10.1148/radiology.159.2.3515425.

  PMID: 3515425 BACKGROUND

• McCowan LM, Figueras F, Anderson NH. Evidence-based national guidelines for the management of suspected fetal growth restriction: comparison, consensus, and controversy. Am J Obstet Gynecol. 2018 Feb;218(2S):S855-S868. doi: 10.1016/j.ajog.2017.12.004.

  PMID: 29422214 BACKGROUND

• Wang YX, Arvizu M, Rich-Edwards JW, Wang L, Rosner B, Stuart JJ, Rexrode KM, Chavarro JE. Hypertensive Disorders of Pregnancy and Subsequent Risk of Premature Mortality. J Am Coll Cardiol. 2021 Mar 16;77(10):1302-1312. doi: 10.1016/j.jacc.2021.01.018.

  PMID: 33706872 BACKGROUND

• Varner S, Sherman C, Lewis D, Owens S, Bodie F, McCathran CE, Holliday N. Amniocentesis for fetal lung maturity: will it become obsolete? Rev Obstet Gynecol. 2013;6(3-4):126-34.

  PMID: 24826202 BACKGROUND

• Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin Summary, Number 222. Obstet Gynecol. 2020 Jun;135(6):1492-1495. doi: 10.1097/AOG.0000000000003892.

  PMID: 32443077 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ahmed H El Sawaf, MD

  Cairo University

  STUDY DIRECTOR

• Ahmed M Salah, MD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: March 31, 2023
• Study Start: April 3, 2023
• Primary Completion: April 4, 2024
• Study Completion: June 7, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

EG (1)