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Completed

NCT Number: NCT03584763

Frequency of Performing Umbilical Artery Doppler in the Third Trimester in High Risk Pregnancy

The aim of the current study was to produce a high quality evidence on the best frequency of performing umbilical artery Doppler for high risk pregnant women in the third trimester.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Maternity Hospital

Cairo, 11221, Egypt

About this study

Nowadays, high risk pregnancy forms a significant increasing proportion of any pregnant population, according to some authors up to 50% of all pregnancies would have the label of high risk pregnancies.

At present, it is recommended that high risk pregnancies, thought to be at risk of placental insufficiency should be monitored with Doppler studies of the umbilical artery. Doppler assessment of the placental circulation plays an important role in screening for impaired placentation and its complications of intrauterine growth restriction.

The purpose of umbilical artery Doppler surveillance is to predict fetal academia thereby allowing timely delivery prior to irreversible end-organ damage and intrauterine fetal death.

According to a Cochrane Pregnancy and Childbirth Group's systematic review and meta-analysis, in which Published and unpublished randomised and quasi-randomised trials evaluating the effects of one or more described antenatal fetal surveillance regimens were searched, the optimal frequency of umbilical artery Doppler surveillance is unclear.

Our randomized controlled study was conducted on patients with high risk pregnancies at their third trimester who attended Ain Shams University Maternity Hospital. A total of 292 high risk pregnant women fulfilling the inclusion criteria were selected by random sampling and divided between two groups with 146 patients in each group. Group I underwent Doppler every other week and Group II underwent Doppler once weekly.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • I-Singleton pregnancy. II-In the third trimester (starting from 28 weeks of gestation till the time of delivery), Gestational age will be determined by the date of the last menstrual period and early ultrasound.

III-Patient considered as high-risk pregnancies will be included in this study.

The following will be considered as high-risk status:

  • Previous obstetric history of preeclampsia or eclampsia, abruptio placenta, intra-uterine growth restriction or still birth.
  • Pre-existing medical disorders like:
  • Pregestational diabetes (Ang et al., 2006)
  • Renal diseases (such as nephrotic syndrome, chronic renal failure, renal transplant and hemodialysis) (Divon and Ferber, 2012).
  • Autoimmune diseases (such as systemic lupus erythromatosis and rheumatoid arthritis) (Divon and Ferber, 2012).
  • Acquired thrombophilias (such as antiphospholipid syndrome). On the other hand, inherited thrombophilias (such as protein C or S deficiency) are not associated with IUGR (Reeves and Galan, 2012).
  • Chronic maternal hypoxemia due to pulmonary disease (such as uncontrolled asthma, chronic obstructive pulmonary disease and cystic fibrosis), cardiac disease (such as cyanotic heart disease) or hematologic disorders (such as severe anemia, sickle cell anemia and β-thalassemia) (Baschat et al., 2012).
  • Current preeclampsia or pregnancy-induced hypertension (PIH). PIH is diagnosed in women whose blood pressure reaches 140/90 mm Hg or greater for the first time after midpregnancy, but proteinuria is not identified. Preeclampsia is best described as pregnancy-specific syndrome that can affect virtually every organ system.It is much more than simply gestational hypertension with proteinuria (Cunningham et al, 2010).

IV- Obtaining valid informed consent to participate in the study

Exclusion criteria

  • I-Patients with congenital anomaly of the fetus. As this will affect fetal outcome with no effect of Doppler changes.

II- Patients with multiple gestations. As they have different growth pattern. III- Patients with unconfirmed Gestational age due to lack of sure reliable date and absent early trimesteric scan. As we cannot diagnose small for gestational age without sure date.

IV- Withdrawal of consent.

Treatment and study plan

Umbilical artery Doppler

Diagnostic Test

Umbilical artery Doppler ultrasound will be performed by most expert sonographer in umbilical artery Doppler at the special care unit, using a 3.5MHz transabdominal probe of SAMSUNG MEDISON, SONOACE R5 ultrasound machine, using the standard protocol of the unit for minimizing the interobserver variations.

Primary outcomes

  1. Neonatal admission to r intensive care unit within the first 24 hours

    Time frame: first 24 hours of life

    Neonatal admission to special care and/or intensive care unit within the first 24 hours

Secondary outcomes

  1. Stillbirth

    Time frame: at delivery

    Stillbirth

  2. Neonatal death

    Time frame: 28 days

    Neonatal death

  3. Fetal acidosis

    Time frame: at delivery

    cord blood pH

  4. Apgar score less than seven at five minutes

    Time frame: 5 minutes

    Apgar score less than seven at five minutes

  5. Induction of labour

    Time frame: 24 hours

    Induction of labour

  6. Preterm labour

    Time frame: 37 weeks

    onset of labour before 37 completed week of pregnancy

  7. Gestational age at birth

    Time frame: 28 weeks

    Gestational age at birth

  8. Infant respiratory distress syndrome

    Time frame: 24 hours

    Infant respiratory distress syndrome

  9. Hypoxic ischaemic encephalopathy

    Time frame: 96 hours

    Hypoxic ischaemic encephalopathy

  10. Intraventricular haemorrage

    Time frame: 96 hours

    Intraventricular haemorrage

  11. Necrotizing enterocolitis

    Time frame: 96 hours

    Necrotizing enterocolitis

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Frequency of Performing Umbilical Artery Doppler in the Third Trimester in High Risk Pregnancy A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2018
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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