Back to resultsUterine Artery Pulsatility Index and Materno Fetal Outcomes (UADLAB)
Primary Purpose
Labor Complication
Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
normal PI
pathological PI
Sponsored by
About this trial
This is an interventional treatment trial for Labor Complication focused on measuring stillbirth, hemorrhage
Eligibility 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
Sites / Locations
- University Hospital BougatfaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
normal PI
pathological PI
Arm Description
Uterine artery PI expresserd in MoM is <95e percentile
Uterine artery PI expressed in Multiple of Mediane (MoM) is >=95e percentile
Outcomes
Primary Outcome Measures
right uterine artery pulsatility index measurement
left uterine artery pulsatility index measurement
Secondary Outcome Measures
maternal outcome
number of patients with hemorrhage, preeclampsie, adversal outcomes
small for gestationnal age (SGA)
number of neonatal SGA
Apgar Score<7
number of birth with Apgar score <7
distress
number of cesarean section for distress
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02853058
Brief Title
Uterine Artery Pulsatility Index and Materno Fetal Outcomes
Acronym
UADLAB
Official Title
Uterine Artery Pulsatility Index During Labor After 34 Weeks in the Prediction of Materno Fetal Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Complication
Keywords
stillbirth, hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
normal PI
Arm Type
Active Comparator
Arm Description
Uterine artery PI expresserd in MoM is <95e percentile
Arm Title
pathological PI
Arm Type
Active Comparator
Arm Description
Uterine artery PI expressed in Multiple of Mediane (MoM) is >=95e percentile
Intervention Type
Radiation
Intervention Name(s)
normal PI
Intervention Description
measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM
Intervention Type
Radiation
Intervention Name(s)
pathological PI
Intervention Description
measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM
Primary Outcome Measure Information:
Title
right uterine artery pulsatility index measurement
Time Frame
15 minutes
Title
left uterine artery pulsatility index measurement
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
maternal outcome
Description
number of patients with hemorrhage, preeclampsie, adversal outcomes
Time Frame
2 days
Title
small for gestationnal age (SGA)
Description
number of neonatal SGA
Time Frame
1 day
Title
Apgar Score<7
Description
number of birth with Apgar score <7
Time Frame
1 day
Title
distress
Description
number of cesarean section for distress
Time Frame
1 day
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AMIRA AYACHI, Ph D
Phone
53660148
Ext
00216
Email
benmrad.amira@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AMIRA AYACHI, Ph D
Organizational Affiliation
University Tunis El Manar
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Bougatfa
City
Bizerte
ZIP/Postal Code
7000
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AMIRA AYACHI, Ph D
Phone
53660148
Ext
00216
Email
benmrad.amira@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Mechaal mouurali, professor
Phone
98693968
Ext
00216
Email
mouralimech@yaho.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25970847
Citation
Valino 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.
Results Reference
background
Learn more about this trial
Uterine Artery Pulsatility Index and Materno Fetal Outcomes
We'll reach out to this number within 24 hrs