Uterine Artery Pulsatility Index and Materno Fetal Outcomes

NCT ID: NCT02853058

Last Updated: 2016-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Labor Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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normal PI

Uterine artery PI expresserd in MoM is \<95e percentile

Group Type ACTIVE_COMPARATOR

normal PI

Intervention Type RADIATION

measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM

pathological PI

Uterine artery PI expressed in Multiple of Mediane (MoM) is \>=95e percentile

Group Type ACTIVE_COMPARATOR

pathological PI

Intervention Type RADIATION

measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM

Interventions

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normal PI

measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM

Intervention Type RADIATION

pathological PI

measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM

Intervention Type RADIATION

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Tunis El Manar

OTHER

Sponsor Role lead

Responsible Party

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Amira Ayachi

University Assistant in Obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AMIRA AYACHI, Ph D

Role: STUDY_CHAIR

University Tunis El Manar

Locations

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University Hospital Bougatfa

Bizerte, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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AMIRA AYACHI, Ph D

Role: CONTACT

53660148 ext. 00216

Facility Contacts

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AMIRA AYACHI, Ph D

Role: primary

53660148 ext. 00216

Mechaal mouurali, professor

Role: backup

98693968 ext. 00216

References

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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.

Reference Type BACKGROUND
PMID: 25970847 (View on PubMed)

Other Identifiers

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UTARTDOP1

Identifier Type: -

Identifier Source: org_study_id

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