Uterine Artery Pulsatility Index and Materno Fetal Outcomes | NCT02853058

Studies
Uterine Artery Pulsatility Index and Materno Fetal Outcomes

NCT02853058

Sponsor

University Tunis El Manar

Status

Unknown status

Last Update Posted

Aug 2, 2016Estimated

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Labor Complication

Interventions

normal PI
pathological PI

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Sep 2016Estimated

Completion Date

Nov 2016Estimated

First Submitted Date

Jul 24, 2016

First Submission Date that Met QC Criteria

Jul 28, 2016

First Posted Date

Aug 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2016

Last Update Posted Date

Aug 2, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amira Ayachi, University Assistant in Obstetrics and gynecology, University Tunis El ManarPrincipal Investigator

Lead Sponsor

University Tunis El ManarOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
normal PI	Active Comparator	Uterine artery PI expresserd in MoM is <95e percentile	Radiation: normal PI
pathological PI	Active Comparator	Uterine artery PI expressed in Multiple of Mediane (MoM) is >=95e percentile	Radiation: pathological PI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
normal PI	Radiation	measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM	normal PI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
right uterine artery pulsatility index measurement		15 minutes
left uterine artery pulsatility index measurement		15 minutes

Secondary Outcomes

Measure	Description	Time Frame
maternal outcome	number of patients with hemorrhage, preeclampsie, adversal outcomes	2 days
small for gestationnal age (SGA)	number of neonatal SGA

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AMIRA AYACHI, Ph D	Contact	53660148	00216	benmrad.amira@yahoo.fr

Overall Officials

Name	Affiliation	Role
AMIRA AYACHI, Ph D	University Tunis El Manar	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Bougatfa	Recruiting	Bizerte		7000	Tunisia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25970847	Background	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.

ID	Term
D007744	Obstetric Labor Complications
D050497	Stillbirth
D006470	Hemorrhage

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005313	Fetal Death