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Uterine Artery Pulsatility Index and Materno Fetal Outcomes (UADLAB)

U

University Tunis El Manar

Status

Unknown

Conditions

Labor Complication

Treatments

Radiation: pathological PI
Radiation: normal PI

Study type

Interventional

Funder types

Other

Identifiers

NCT02853058
UTARTDOP1

Details and patient eligibility

About

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

Full 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.

Enrollment

600 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

600 participants in 2 patient groups

normal PI
Active Comparator group
Description:
Uterine artery PI expresserd in MoM is \<95e percentile
Treatment:
Radiation: normal PI
pathological PI
Active Comparator group
Description:
Uterine artery PI expressed in Multiple of Mediane (MoM) is \>=95e percentile
Treatment:
Radiation: pathological PI

Trial contacts and locations

1

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Central trial contact

AMIRA AYACHI, Ph D

Data sourced from clinicaltrials.gov

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