Hypertension in Pregnancy Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | June 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasralainy Cairo University | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Buchanan TA, Xiang AH. Gestational diabetes mellitus. J Clin Invest. 2005 Mar;115(3):485-91. doi: 10.1172/JCI24531. — View Citation
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. — View Citation
Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin Summary, Number 222. Obstet Gynecol. 2020 Jun;135(6):1492-1495. doi: 10.1097/AOG.0000000000003892. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The pulsatility index (PI) of fetal pulmonary artery Doppler in neonates needing respiratory support | The PI will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome | Baseline | |
Secondary | The resistance index (RI) of fetal pulmonary artery Doppler in neonates needing respiratory support | The RI will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome | baseline | |
Secondary | The systolic to diastolic ratio (S/D) of fetal pulmonary artery Doppler in neonates needing respiratory support | The S/D ratio will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome | baseline | |
Secondary | The peak systolic velocity (PSV) of fetal pulmonary artery Doppler in neonates needing respiratory support | The PSV will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome | baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00974714 -
L-arginine Effects on Chronic Hypertension in Pregnancy
|
Phase 3 | |
Terminated |
NCT03595982 -
Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?
|
Phase 4 | |
Completed |
NCT04486170 -
Assessment of Postpartum Education to Improve Compliance
|
N/A | |
Completed |
NCT03506724 -
Response to Anti-hypertensives in Pregnant and Postpartum Patients
|
Phase 4 | |
Completed |
NCT03613714 -
Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy
|
N/A | |
Recruiting |
NCT04604535 -
The BEET-BP Trial - Investigating the Effect of Dietary Nitrates on Hypertension in Pregnancy
|
N/A | |
Completed |
NCT00412230 -
Insulin Resistance and Hypertensive Disorders in Pregnancy
|
N/A | |
Active, not recruiting |
NCT05049616 -
Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension
|
Phase 4 | |
Completed |
NCT04119232 -
Randomized Clinical Trial to Increase Physical Activity After a a Hypertensive Pregnancy
|
N/A | |
Completed |
NCT04633551 -
Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
|
N/A | |
Completed |
NCT05859282 -
Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension
|
||
Active, not recruiting |
NCT05543265 -
Bridging the Gap From Postpartum to Primary Care
|
N/A | |
Completed |
NCT00571766 -
Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy
|
Phase 3 | |
Recruiting |
NCT05473767 -
Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children
|
N/A | |
Recruiting |
NCT05683093 -
Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood
|
||
Completed |
NCT06403722 -
Perinatal Outcomes in Patients With Elevated sFlt-1/PlGF Ratio
|
||
Recruiting |
NCT05852054 -
Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)
|
Phase 3 | |
Recruiting |
NCT05137808 -
Understanding Blood Pressure Changes After Birth
|
||
Completed |
NCT03961360 -
Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03648645 -
Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure
|
N/A |