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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03584763
Recruitment Status : Unknown
Verified June 2018 by Mohamed Hamed Salama, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Hamed Salama, Ain Shams University

Tracking Information
First Submitted Date  ICMJE June 29, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date July 12, 2018
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
  • Stillbirth [ Time Frame: at delivery ]
    Stillbirth
  • Neonatal death [ Time Frame: 28 days ]
    Neonatal death
  • Fetal acidosis [ Time Frame: at delivery ]
    cord blood pH
  • Apgar score less than seven at five minutes [ Time Frame: 5 min ]
    Apgar score less than seven at five minutes
  • Induction of labour [ Time Frame: 24 hours ]
    Induction of labour
  • Preterm labour [ Time Frame: 37 weeks ]
    onset of labour before 37 completed week of pregnancy
  • Gestational age at birth [ Time Frame: 28 weeks ]
    Gestational age at birth
  • Infant respiratory distress syndrome [ Time Frame: 24 hours ]
    Infant respiratory distress syndrome
  • Hypoxic ischaemic encephalopathy [ Time Frame: 96 hours ]
    Hypoxic ischaemic encephalopathy
  • Intraventricular haemorrage [ Time Frame: 96 hours ]
    Intraventricular haemorrage
  • Necrotizing enterocolitis [ Time Frame: 96 hours ]
    Necrotizing enterocolitis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Frequency of Performing Umbilical Artery Doppler in the Third Trimester in High Risk Pregnancy
Official Title  ICMJE Frequency of Performing Umbilical Artery Doppler in the Third Trimester in High Risk Pregnancy A Randomized Controlled Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE High Risk Pregnancy
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: Bi-Weekly Umbilical Artery Doppler
    will undergo Doppler every other week
    Intervention: Diagnostic Test: Umbilical artery Doppler
  • Experimental: Weekly Umbilical Artery Doppler
    will undergo Doppler every week
    Intervention: Diagnostic Test: Umbilical artery Doppler
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 29, 2018)
292
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2018
Estimated Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584763
Other Study ID Numbers  ICMJE HRD2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.

Responsible Party Mohamed Hamed Salama, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ashraf F Nabhan, Professor Faculty of Medicine, Ain Shams University
PRS Account Ain Shams University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP