Hypertension in PregnancyNCT05793125
Pulmonary Artery Doppler And Neonatal Outcome In Hypertensive Disorders Of Pregnancy
An observational study of Hypertension in Pregnancy, run by Cairo University at 1 site in Egypt.
Trial summary
To correlate fetal Pulmonary artery Doppler parameters with neonatal outcome in patients diagnosed with hypertensive disorders of pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Hypertension in Pregnancy
- What is being tested?
- Ultrasonography
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2023to 7 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Adult
Study population: Pregnant patients diagnosed with hypertensive disorders undergoing elective or emergency termination of pregnancy in Kasr Alainy hospital.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypertension in Pregnancy
- Being tested
- Ultrasonography
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (4)
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
Measured: Baseline
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
Measured: baseline
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
Measured: baseline
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start3 Apr 2023
- Primary completion4 Apr 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noran Amin, Cairo University
- Investigators
- Ahmed H El Sawaf, MD, Study director, Cairo UniversityAhmed M Salah, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793125
- Sponsor's protocol ID
- Pregnancy induced hypertension
- Status last verified
- Nov 2024
- First submitted
- 19 Mar 2023
- Last updated
- 15 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31135728Buchanan TA, Xiang AH. Gestational diabetes mellitus. J Clin Invest. 2005 Mar;115(3):485-91. doi: 10.1172/JCI24531.
PubMed 15765129Churchill 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.
PubMed 30289565Hornberger LK, Sahn DJ. Rhythm abnormalities of the fetus. Heart. 2007 Oct;93(10):1294-300. doi: 10.1136/hrt.2005.069369. No abstract available.
PubMed 17890709Katsuragi 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.
PubMed 29699420Mahony 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.
PubMed 3515425McCowan 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.
PubMed 29422214Wang 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.
PubMed 33706872Varner 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.
PubMed 24826202Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin Summary, Number 222. Obstet Gynecol. 2020 Jun;135(6):1492-1495. doi: 10.1097/AOG.0000000000003892.
PubMed 32443077
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Pulmonary Artery Doppler And Neonatal Outcome In Hypertensive Disorders Of Pregnancy
- ClinicalTrials.gov ID
- NCT05793125
- Acronym / sponsor ID
- Pregnancy induced hypertension
- Conditions
- Hypertension in Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To correlate fetal Pulmonary artery Doppler parameters with neonatal outcome in patients diagnosed with hypertensive disorders of pregnancy.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant patients diagnosed with hypertensive disorders undergoing elective or emergency termination of pregnancy in Kasr Alainy hospital.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyA 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. | Device | – |
Primary outcome
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
4 secondary outcomes
The pulsatility index (PI) of fetal pulmonary artery Doppler in neonates needing respiratory support
Time frame: Baseline
The resistance index (RI) of fetal pulmonary artery Doppler in neonates needing respiratory support
Time frame: baseline
The systolic to diastolic ratio (S/D) of fetal pulmonary artery Doppler in neonates needing respiratory support
Time frame: baseline
The peak systolic velocity (PSV) of fetal pulmonary artery Doppler in neonates needing respiratory support
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Background: PubMed 31135728Judy 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.
- Background: PubMed 15765129Buchanan TA, Xiang AH. Gestational diabetes mellitus. J Clin Invest. 2005 Mar;115(3):485-91. doi: 10.1172/JCI24531.
- Background: PubMed 30289565Churchill 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.
- Background: PubMed 17890709Hornberger LK, Sahn DJ. Rhythm abnormalities of the fetus. Heart. 2007 Oct;93(10):1294-300. doi: 10.1136/hrt.2005.069369. No abstract available.
- Background: PubMed 29699420Katsuragi 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.
- Background: PubMed 3515425Mahony 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.
- Background: PubMed 29422214McCowan 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.
- Background: PubMed 33706872Wang 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.
- Background: PubMed 24826202Varner 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.
- Background: PubMed 32443077Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin Summary, Number 222. Obstet Gynecol. 2020 Jun;135(6):1492-1495. doi: 10.1097/AOG.0000000000003892.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed H El Sawaf, MD study director
Cairo University
Ahmed M Salah, MD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension in Pregnancy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceleration time to ejection time ratio (At/Et) of fetal pulmonary artery Doppler in neonates needing respiratory support (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05793125, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.