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Uterine Artery Pulsatility Index and Materno Fetal Outcomes (UADLAB)

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ClinicalTrials.gov Identifier: NCT02853058
Recruitment Status : Unknown
Verified July 2016 by Amira Ayachi, University Tunis El Manar.
Recruitment status was:  Recruiting
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Amira Ayachi, University Tunis El Manar

Tracking Information
First Submitted Date  ICMJE July 24, 2016
First Posted Date  ICMJE August 2, 2016
Last Update Posted Date August 2, 2016
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
  • right uterine artery pulsatility index measurement [ Time Frame: 15 minutes ]
  • left uterine artery pulsatility index measurement [ Time Frame: 15 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
  • maternal outcome [ Time Frame: 2 days ]
    number of patients with hemorrhage, preeclampsie, adversal outcomes
  • small for gestationnal age (SGA) [ Time Frame: 1 day ]
    number of neonatal SGA
  • Apgar Score<7 [ Time Frame: 1 day ]
    number of birth with Apgar score <7
  • distress [ Time Frame: 1 day ]
    number of cesarean section for distress
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 Uterine Artery Pulsatility Index and Materno Fetal Outcomes
Official Title  ICMJE Uterine Artery Pulsatility Index During Labor After 34 Weeks in the Prediction of Materno Fetal Outcomes
Brief Summary High Uterine artery index pulsatility (PI) is associated with small for gestationnal age but also with stillbirth and distress during labor.
Detailed Description measures of Uterine artery PI is made with transabdominal color flow during labor. The right and left uterine arteries are visualized at the crossover wth the external iliac arteries. PI is measured and the mean PI of the two vessels is calculated and expressed as multiple of the median (MoM).The outcomes stillbirth, distress and vaginal or cesarean delivery, apgar sore <7 at 5 minutes, birth weight and maternal outcomes: preeclampsia, hemorrhage and other complications are noted.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Labor Complication
Intervention  ICMJE
  • Radiation: normal PI
    measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM
  • Radiation: pathological PI
    measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM
Study Arms  ICMJE
  • Active Comparator: normal PI
    Uterine artery PI expresserd in MoM is <95e percentile
    Intervention: Radiation: normal PI
  • Active Comparator: pathological PI
    Uterine artery PI expressed in Multiple of Mediane (MoM) is >=95e percentile
    Intervention: Radiation: pathological PI
Publications * Valiño N, Giunta G, Gallo DM, Akolekar R, Nicolaides KH. Uterine artery pulsatility index at 30-34 weeks' gestation in the prediction of adverse perinatal outcome. Ultrasound Obstet Gynecol. 2016 Mar;47(3):308-15. doi: 10.1002/uog.14898. Epub 2016 Feb 1.

*   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: July 28, 2016)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • gestationnal age >=34 weeks
  • during labor

Exclusion Criteria:

  • elective cesarean even if labor
  • non elligible ultrasound criteria of good measurement of uterine artery PI
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02853058
Other Study ID Numbers  ICMJE UTARTDOP1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Amira Ayachi, University Tunis El Manar
Study Sponsor  ICMJE University Tunis El Manar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: AMIRA AYACHI, Ph D University Tunis El Manar
PRS Account University Tunis El Manar
Verification Date July 2016

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