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Uterine Artery Pulsatility Index and Materno Fetal Outcomes (UADLAB)

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: 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

Brief Summary:
High Uterine artery index pulsatility (PI) is associated with small for gestationnal age but also with stillbirth and distress during labor.

Condition or disease Intervention/treatment Phase
Labor Complication Radiation: normal PI Radiation: pathological PI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Uterine Artery Pulsatility Index During Labor After 34 Weeks in the Prediction of Materno Fetal Outcomes
Study Start Date : July 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : November 2016

Arm Intervention/treatment
Active Comparator: normal PI
Uterine artery PI expresserd in MoM is <95e percentile
Radiation: normal PI
measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM

Active Comparator: pathological PI
Uterine artery PI expressed in Multiple of Mediane (MoM) is >=95e percentile
Radiation: pathological PI
measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM




Primary Outcome Measures :
  1. right uterine artery pulsatility index measurement [ Time Frame: 15 minutes ]
  2. left uterine artery pulsatility index measurement [ Time Frame: 15 minutes ]

Secondary Outcome Measures :
  1. maternal outcome [ Time Frame: 2 days ]
    number of patients with hemorrhage, preeclampsie, adversal outcomes

  2. small for gestationnal age (SGA) [ Time Frame: 1 day ]
    number of neonatal SGA

  3. Apgar Score<7 [ Time Frame: 1 day ]
    number of birth with Apgar score <7

  4. distress [ Time Frame: 1 day ]
    number of cesarean section for distress



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02853058


Contacts
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Contact: AMIRA AYACHI, Ph D 53660148 ext 00216 benmrad.amira@yahoo.fr

Locations
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Tunisia
University Hospital Bougatfa Recruiting
Bizerte, Tunisia, 7000
Contact: AMIRA AYACHI, Ph D    53660148 ext 00216    benmrad.amira@yahoo.fr   
Contact: Mechaal mouurali, professor    98693968 ext 00216    mouralimech@yaho.fr   
Sponsors and Collaborators
University Tunis El Manar
Investigators
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Study Chair: AMIRA AYACHI, Ph D University Tunis El Manar
Publications:
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Responsible Party: Amira Ayachi, University Assistant in Obstetrics and gynecology, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT02853058    
Other Study ID Numbers: UTARTDOP1
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Amira Ayachi, University Tunis El Manar:
stillbirth
hemorrhage
Additional relevant MeSH terms:
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Obstetric Labor Complications
Pregnancy Complications