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

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ClinicalTrials.gov Identifier: NCT03584763
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Hamed Salama, Ain Shams University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
High Risk Pregnancy Diagnostic Test: Umbilical artery Doppler Not Applicable

Detailed Description:

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According to a Cochrane Pregnancy and Childbirth Group's systematic review and meta-analysis, in which Published and unpublished randomised and quasi-randomised trials evaluating the effects of one or more described antenatal fetal surveillance regimens were searched, the optimal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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Blinding of the patients or staff in this study is not generally feasible. However, the measured outcomes in this study are objective and are unlikely to be biased by lack of blinding.
Primary Purpose: Prevention
Official Title: Frequency of Performing Umbilical Artery Doppler in the Third Trimester in High Risk Pregnancy A Randomized Controlled Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : August 1, 2018

Arm Intervention/treatment
Active Comparator: Bi-Weekly Umbilical Artery Doppler
will undergo Doppler every other week
Diagnostic Test: Umbilical artery Doppler
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.

Experimental: Weekly Umbilical Artery Doppler
will undergo Doppler every week
Diagnostic Test: Umbilical artery Doppler
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 Outcome Measures :
  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 Outcome Measures :
  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 min ]
    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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

  1. Previous obstetric history of preeclampsia or eclampsia, abruptio placenta, intra-uterine growth restriction or still birth.
  2. Pre-existing medical disorders like:

    1. Pregestational diabetes (Ang et al., 2006)
    2. Renal diseases (such as nephrotic syndrome, chronic renal failure, renal transplant and hemodialysis) (Divon and Ferber, 2012).
    3. Autoimmune diseases (such as systemic lupus erythromatosis and rheumatoid arthritis) (Divon and Ferber, 2012).
    4. 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).
    5. 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).
  3. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584763


Contacts
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Contact: Ashraf F Nabhan, Professor 00201223317347 ashraf.nabhan@gmail.com
Contact: Mohamed H Salama, Lecturer 00201226067272 mhs_vagus2009@yahoo.com

Locations
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Egypt
Ain Shams University Maternity Hospital Recruiting
Cairo, Egypt, 11221
Contact: Hanan H Rizk, Specialist    0021226804755    hananhanna86@gmail.com   
Contact: Mohamed H Salama, Lecturer    00201226067272    mhs_vagus2009@yahoo.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Ashraf F Nabhan, Professor Faculty of Medicine, Ain Shams University

Publications of Results:
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Responsible Party: Mohamed Hamed Salama, Lecturer of Obstetrics and Gynaecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03584763     History of Changes
Obsolete Identifiers: NCT03562598
Other Study ID Numbers: HRD2010
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

The Investigator will make certain that an appropriate informed consent process is in place to ensure that potential research subjects are fully informed about the nature and objectives of the clinical study, the potential risks and benefits of study participation and their rights as research subjects.

The Investigator will obtain the written, signed informed consent of each subject prior to performing any study-specific procedures. The Investigator will retain the original signed informed consent form.

Personal information will not be collected or shared. Unique personal data will be her hospital number.

Participants files will be maintained in storage for a period of 3 years after completion of the study.


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