Pre-EclampsiaNCT03515759
Fetal Doppler Indices in Predicting Perinatal Outcome Among Severely Hypertensive Pregnant Patients.
An observational study of Pre-Eclampsia and IUGR, run by Cairo University at 1 site in Egypt.
Trial summary
60 pregnant women with singleton living fetus between 34 -38 wks gestation known to have severe hypertension in the current pregnancy were included. All participants underwent Doppler ultrasonography to evaluate the Feto-Placental Circulation within 24 hours from Pregnancy Termination. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pre-Eclampsia, IUGR
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 15 Jan 2019
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: 60 pregnant women with singleton living fetus between 34 -38 wks gestation known to have severe hypertension in the current pregnancy were included.
Who may be able to join
- Gestational age (GA): 34 - 38weeks of gestations (confirmed by a reliable date for the last menstrual period or /and 1st trimester ultrasound scan).
- The current Pregnancy complicated with severe hypertension (gestational hypertension, preeclampsia, chronic hypertension and chronic hypertension with superimposed preeclampsia).
- Singleton living fetus.
Who cannot join
- Maternal medical disorders rather than hypertension.
- Fetal congenital anomalies.
- Rupture of membrane.
- Antepartum hemorrhage (placenta previa or accidental hemorrhage).
- The maternal administration of respiratory depressants within 2 hours from the delivery of the fetus (e. g., opioid analgesic )
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr Elainy Hospital (Faculty of Medicine - Cairo University)
Cairo, 115431
About this study
Official title: The Efficacy of Fetal Arterial and Venous Doppler Indices in Predicting Perinatal Outcome Among Severely Hypertensive Pregnant Patients.
60 pregnant women with singleton living fetus between 34 -38 wks gestation known to have severe hypertension in the current pregnancy were included.
All participants underwent Doppler ultrasonography to evaluate the Feto-Placental Circulation within 24 hours from Pregnancy Termination.
Flow Velocity Waveforms were obtained from: Umbilical Artery (UA), Middle Cerebral Artery (MCA), Ductus Venosus (DV), Umbilical Vein (UV).
From the flow velocity waveforms the following indices were measured:
UA \& MCA: Pulsatility Index (PI) \& Resistance Index (RI), DV: Peak Velocity Index For veins (PVIV), Peak Systolic Velocity (PSV) \& a- wave.
UV Flow: Presence or Absence of Pulsatile Flow.
Read the detailed description
60 pregnant women (aged from 18- 35 years) with singleton healthy living fetus between 34 -38 wks gestation known to have severe hypertension in the current pregnancy were included.
Chronic Hypertension was defined as a blood pressure value of 140/90 mm Hg or higher diagnosed before 20 weeks' gestation or preconception. Gestational Hypertension was defined as blood pressure value of 140/90 mm Hg or higher on 2 occasions at least 4 hours apart that occurred after 20 weeks' gestation in a patient with previously normal blood pressure. Preeclampsia was defined as blood pressure value of 140/90 mm Hg or higher on 2 occasions at least 4 hours apart and proteinuria (Proteinuria is defined as the excretion of 300mg or more of protein in a 24 hour urine collection or 1+ by The dipstick method) that occurred after 20 weeks' gestation in a patient with previously normal blood pressure. Chronic hypertension \& gestational hypertension was considered to be severe if systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg, or both \& persists for 15 minutes or more. Preeclampsia was considered to be severe in the following conditions: Blood pressure of 160/110 or more, Thrombocytopenia (platelet count less than 1000,000 / microliter), impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration) , severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by alternative diagnosis, or both, the new development of renal insufficiency (elevated serum creatinine > 1.1mg/dL or a doubling of serum creatinine in the absence of other renal disease) \& new-onset cerebral or visual disturbances. Patients with other maternal medical disorders rather than hypertension or experienced rupture of membrane or antepartum hemorrhage (placenta previa or accidental hemorrhage) were excluded. Also, patients who received respiratory depressants medications within 2 hours from the delivery of the fetus (e. g., opioid analgesic) were excluded.
Informed consents were obtained from all participants after explanation of the study and its aims. All participants underwent the following: Full history taking including a detailed history of the hypertension state during the current pregnancy (onset, course, current medication, and whether the blood pressure is controlled or not). complete physical examination: general (including BMI \& blood pressure measurement) and obstetric examinations. Routine obstetric ultrasound: to confirm gestational age \& fetal viability \& number, assess fetal weight (EFW) and growth percentile \& amniotic fluid index (AFI) \& to exclude fetal anomalies. Laboratory investigations (Complete blood count (CBC) - Urine analysis for albuminuria - Liver enzymes \& kidney function). In addition to Doppler ultrasonography assessment using GE Voluson Pro-V and GE Voluson E10 with 3.5-5 MHz abdominal transducer). The color flow imaging (to identify the vessels) \& pulsed wave velocimetry was used to obtain flow velocity waveforms within 24 hours of pregnancy termination from: Umbilical artery (UA): from a free-floating loop in the mid portion of the cord, Middle cerebral artery (MCA): obtained from a transverse image of the fetal head at the level of sphenoid bones (color flow im¬aging was used to display the circle of Willis), Ductus venosus (DV) was sampled soon after its origin from the umbilical vein \& finally Umbilical vein flow (UV) assessment. In all Doppler studies, while the woman is lying in a semi-recumbent position, the angle of insonation of the vessels is < 45 degrees \& the high-pass filter is set at 100 Hz. Care is taken not to exert undue pressure on the fetal head because this alters the flow velocity waveforms from the MCA. Furthermore, examination of the fetal vessels was performed in the absence of fetal body and respiratory movements, with a fetal heart rate ranging from 120-160 bpm. Measurements was obtained from ≥ 4 consecutive flow velocity waveforms of good quality and averaged. From the flow velocity waveforms of the UA \& MCA, the pulsatility index (PI) \& the resistance index (RI) was measured. From the flow velocity waveforms of the DV, peak velocity index (PVIV), peak systolic velocity (PSV) and A wave was measured. From the umbilical vein flow, the presence or absence of pulsatile flow was recorded. All labours was attended by an expert neonatologist who was blinded to the results of Doppler indices measurements \& the following was recorded: APGAR score at (1 \& 5 min) - Neonatal birth weight (Fetal growth restriction will defined as birth weight of less than 10th percentile of newborn weight in normal pregnancies at corresponding gestational age) - the occurrence of respiratory complications [Transient Tachypnea of the newborn (TTN) or Respiratory Distress Syndrome (RDS)] - The further need for neonatal intensive care unit (NICU) admission \& Perinatal death.
- Conditions
- Pre-Eclampsia, IUGR
- Keywords
- PREECLAMPSIA, DOPPLER, IUGR, UMBILICAL ARTERY, MIDDLE CEREBRAL ARTERY
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hypertensive patients | 60 pregnant women with singleton living fetus between 34 -38 wks gestation known to have severe hypertension in the current pregnancy were included |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic value of umbilical artery (UA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among severely hypertensive patients
sensitivity and specificity of umbilical artery RI \& PI in detecting IUGR and APGAR score less than 7 at 5 minutes
Measured: within 24 hours before delivery and post natal
Secondary outcomes (3)
The diagnostic value of Middle cerebral artery (MCA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among severely hypertensive patients
sensitivity and specificity of middle cerebral artery RI \& PI in detecting IUGR and APGAR score less than 7 at 5 minutes
Measured: within 24 hours before delivery and post natal
The diagnostic value of cerebro/placentaI Ratio in predicting adverse perinatal outcome among severely hypertensive patients.
sensitivity and specificity of of MCA/UA PI Ratio in detecting IUGR and APGAR score less than 7 at 5 minutes
Measured: within 24 hours before delivery and post natal
The diagnostic value of Ductus Venousus Doppler indices in predicting adverse perinatal outcome among severely hypertensive patients.
sensitivity and specificity of peak velocity index (PVIV), peak systolic velocity (PSV) and abnormal A wave in detecting IUGR and APGAR score less than 7 at 5 minutes
Measured: within 24 hours before delivery and post natal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Nov 2017
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moutaz Sherbini, Cairo University
- Investigators
- moutaz elsherbini, MD, Principal investigator, Assistant professor of obstetrics and gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515759
- Sponsor's protocol ID
- 2062010
- Status last verified
- Apr 2018
- First submitted
- 23 Apr 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Fetal Arterial and Venous Doppler Indices in Predicting Perinatal Outcome Among Severely Hypertensive Pregnant Patients.
- ClinicalTrials.gov ID
- NCT03515759
- Acronym / sponsor ID
- 2062010
- Conditions
- Pre-Eclampsia, IUGR
- Keywords
- PREECLAMPSIA, DOPPLER, IUGR, UMBILICAL ARTERY, MIDDLE CEREBRAL ARTERY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 4 May 2018 (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.
60 pregnant women with singleton living fetus between 34 -38 wks gestation known to have severe hypertension in the current pregnancy were included.
All participants underwent Doppler ultrasonography to evaluate the Feto-Placental Circulation within 24 hours from Pregnancy Termination.
Flow Velocity Waveforms were obtained from: Umbilical Artery (UA), Middle Cerebral Artery (MCA), Ductus Venosus (DV), Umbilical Vein (UV).
From the flow velocity waveforms the following indices were measured:
UA \& MCA: Pulsatility Index (PI) \& Resistance Index (RI), DV: Peak Velocity Index For veins (PVIV), Peak Systolic Velocity (PSV) \& a- wave.
UV Flow: Presence or Absence of Pulsatile Flow.
Detailed description
60 pregnant women (aged from 18- 35 years) with singleton healthy living fetus between 34 -38 wks gestation known to have severe hypertension in the current pregnancy were included.
Chronic Hypertension was defined as a blood pressure value of 140/90 mm Hg or higher diagnosed before 20 weeks' gestation or preconception. Gestational Hypertension was defined as blood pressure value of 140/90 mm Hg or higher on 2 occasions at least 4 hours apart that occurred after 20 weeks' gestation in a patient with previously normal blood pressure. Preeclampsia was defined as blood pressure value of 140/90 mm Hg or higher on 2 occasions at least 4 hours apart and proteinuria (Proteinuria is defined as the excretion of 300mg or more of protein in a 24 hour urine collection or 1+ by The dipstick method) that occurred after 20 weeks' gestation in a patient with previously normal blood pressure. Chronic hypertension \& gestational hypertension was considered to be severe if systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg, or both \& persists for 15 minutes or more. Preeclampsia was considered to be severe in the following conditions: Blood pressure of 160/110 or more, Thrombocytopenia (platelet count less than 1000,000 / microliter), impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration) , severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by alternative diagnosis, or both, the new development of renal insufficiency (elevated serum creatinine > 1.1mg/dL or a doubling of serum creatinine in the absence of other renal disease) \& new-onset cerebral or visual disturbances. Patients with other maternal medical disorders rather than hypertension or experienced rupture of membrane or antepartum hemorrhage (placenta previa or accidental hemorrhage) were excluded. Also, patients who received respiratory depressants medications within 2 hours from the delivery of the fetus (e. g., opioid analgesic) were excluded.
Informed consents were obtained from all participants after explanation of the study and its aims. All participants underwent the following: Full history taking including a detailed history of the hypertension state during the current pregnancy (onset, course, current medication, and whether the blood pressure is controlled or not). complete physical examination: general (including BMI \& blood pressure measurement) and obstetric examinations. Routine obstetric ultrasound: to confirm gestational age \& fetal viability \& number, assess fetal weight (EFW) and growth percentile \& amniotic fluid index (AFI) \& to exclude fetal anomalies. Laboratory investigations (Complete blood count (CBC) - Urine analysis for albuminuria - Liver enzymes \& kidney function). In addition to Doppler ultrasonography assessment using GE Voluson Pro-V and GE Voluson E10 with 3.5-5 MHz abdominal transducer). The color flow imaging (to identify the vessels) \& pulsed wave velocimetry was used to obtain flow velocity waveforms within 24 hours of pregnancy termination from: Umbilical artery (UA): from a free-floating loop in the mid portion of the cord, Middle cerebral artery (MCA): obtained from a transverse image of the fetal head at the level of sphenoid bones (color flow im¬aging was used to display the circle of Willis), Ductus venosus (DV) was sampled soon after its origin from the umbilical vein \& finally Umbilical vein flow (UV) assessment. In all Doppler studies, while the woman is lying in a semi-recumbent position, the angle of insonation of the vessels is < 45 degrees \& the high-pass filter is set at 100 Hz. Care is taken not to exert undue pressure on the fetal head because this alters the flow velocity waveforms from the MCA. Furthermore, examination of the fetal vessels was performed in the absence of fetal body and respiratory movements, with a fetal heart rate ranging from 120-160 bpm. Measurements was obtained from ≥ 4 consecutive flow velocity waveforms of good quality and averaged. From the flow velocity waveforms of the UA \& MCA, the pulsatility index (PI) \& the resistance index (RI) was measured. From the flow velocity waveforms of the DV, peak velocity index (PVIV), peak systolic velocity (PSV) and A wave was measured. From the umbilical vein flow, the presence or absence of pulsatile flow was recorded. All labours was attended by an expert neonatologist who was blinded to the results of Doppler indices measurements \& the following was recorded: APGAR score at (1 \& 5 min) - Neonatal birth weight (Fetal growth restriction will defined as birth weight of less than 10th percentile of newborn weight in normal pregnancies at corresponding gestational age) - the occurrence of respiratory complications [Transient Tachypnea of the newborn (TTN) or Respiratory Distress Syndrome (RDS)] - The further need for neonatal intensive care unit (NICU) admission \& Perinatal death.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypertensive patients | – | –60 pregnant women with singleton living fetus between 34 -38 wks gestation known to have severe hypertension in the current pregnancy were included |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 60 pregnant women with singleton living fetus between 34 -38 wks gestation known to have severe hypertension in the current pregnancy were included.
Key inclusion criteria (3 listed)
- Gestational age (GA): 34 - 38weeks of gestations (confirmed by a reliable date for the last menstrual period or /and 1st trimester ultrasound scan).
- The current Pregnancy complicated with severe hypertension (gestational hypertension, preeclampsia, chronic hypertension and chronic hypertension with superimposed preeclampsia).
- Singleton living fetus.
Key exclusion criteria (5 listed)
- Maternal medical disorders rather than hypertension.
- Fetal congenital anomalies.
- Rupture of membrane.
- Antepartum hemorrhage (placenta previa or accidental hemorrhage).
- The maternal administration of respiratory depressants within 2 hours from the delivery of the fetus (e. g., opioid analgesic )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The diagnostic value of umbilical artery (UA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among severely hypertensive patients
Time frame: within 24 hours before delivery and post natal
sensitivity and specificity of umbilical artery RI \& PI in detecting IUGR and APGAR score less than 7 at 5 minutes
3 secondary outcomes
The diagnostic value of Middle cerebral artery (MCA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among severely hypertensive patients
Time frame: within 24 hours before delivery and post natal
The diagnostic value of cerebro/placentaI Ratio in predicting adverse perinatal outcome among severely hypertensive patients.
Time frame: within 24 hours before delivery and post natal
The diagnostic value of Ductus Venousus Doppler indices in predicting adverse perinatal outcome among severely hypertensive patients.
Time frame: within 24 hours before delivery and post natal
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 Feb 2019.
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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.
moutaz elsherbini, MD principal investigator
Assistant professor of obstetrics and gynecology
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 Pre-Eclampsia and IUGR, 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 3 inclusion and 5 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 Feb 2019. 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?
The diagnostic value of umbilical artery (UA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among severely hypertensive patients (time frame: within 24 hours before delivery and post natal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2019.