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Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia

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ClinicalTrials.gov Identifier: NCT03838887
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Sherif Elsirgany, National Research Center, Egypt

Brief Summary:
• Preeclampsia is a multisystem disorder that can cause considerable maternal and fetal morbidity and mortality. Late preeclampsia (with delivery >34 weeks) is more frequent and less serious than early preeclampsia (with delivery <34 weeks). Poor early placentation has been especially associated with early disease. Early identification of women at risk of preeclampsia is currently a crucial aim of antenatal care since they may benefit from prophylactic treatment and increased surveillance.

Condition or disease Intervention/treatment
Pre-Eclampsia Device: ultrasound machine

Detailed Description:
  • The introduction of three-dimensional (3D) ultrasound techniques, with the option of calculating placental volume and measuring vascular indices, has created an excellent opportunity to study early changes in the uteroplacental circulation space, which includes the maternal spiral arteries and the intervillous space. This technology may allow a more direct evaluation of the abnormal placentation process thought to herald the development of preeclampsia.
  • The aim of this study was to assess the usefulness of placental volume and 3D vascular indices as reliable predictors of early preeclampsia in comparison to uterine artery Doppler

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia
Estimated Study Start Date : February 10, 2019
Estimated Primary Completion Date : February 10, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
control group

Pregnant women:

  1. Age between 18-35 years
  2. Parity: primigravidas and multiparas.
  3. Have no history of preeclampsia or eclampsia.
  4. Have no history of chronic hypertension.
  5. Not diabetic.
  6. Not have antiphospholipid syndrome.
  7. Not have autoimmune disease such as SLE
Device: ultrasound machine
Ultrasound machine with a vocal software

High risk group

Pregnant women with:

  1. History of preeclampsia -Eclapmsia
  2. Chronic hypertension
  3. Diabetic
  4. Antiphospholipid syndrome.
  5. Autoimmune syndrome such as SLE.
Device: ultrasound machine
Ultrasound machine with a vocal software




Primary Outcome Measures :
  1. placental vascular indices in prediction of preeclampsia [ Time Frame: one year ]
    placental vascular indices in prediction of preeclampsia compared to uterine artery doppler in prediction of preeclampsia



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   examination of pregnant women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All pregnant women will be examined for antenatal care in the outpatient clinic and fetal medicine unit of obstetrics and gynecology department then they will be divided into two groups control and high risk
Criteria

Inclusion Criteria:

  • A. Control group: Pregnant women:

    1. Age between 18-35 years
    2. Parity: primigravidas and multiparas.
    3. Have no history of preeclampsia or eclampsia.
    4. Have no history of chronic hypertension.
    5. Not diabetic.
    6. Not have antiphospholipid syndrome.
    7. Not have autoimmune disease such as SLE.

B. High risk group: Pregnant women with:

  1. History of preeclampsia -Eclapmsia
  2. Chronic hypertension
  3. Diabetic
  4. Antiphospholipid syndrome.
  5. Autoimmune syndrome such as SLE.

Exclusion Criteria:

  • • Smoking

    • Dichorionic placentae
    • Fetal anomaly
    • Uterine fibroid at the site of placental implantation
    • Subchorionic hematoma

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Responsible Party: Sherif Elsirgany, Researcher ,Family Planning and Reproductive Health Department, National Research Center, Egypt
ClinicalTrials.gov Identifier: NCT03838887     History of Changes
Other Study ID Numbers: placental vascular indices
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications