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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Egypt

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 groups in NCT03515759
Study groupRoleWhat they receive
hypertensive patients60 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted4 May 2018
  2. Study start1 Nov 2017
  3. Primary completion15 Jan 2019
  4. Study completion15 Jan 2019

Resources

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)
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

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.

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