NCT02853058

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

August 2, 2016

Status Verified

July 1, 2016

Enrollment Period

2 months

First QC Date

July 24, 2016

Last Update Submit

July 28, 2016

Conditions

Labor Complication

Keywords

stillbirthhemorrhage

Outcome Measures

Primary Outcomes (2)

  • right uterine artery pulsatility index measurement

    15 minutes

  • left uterine artery pulsatility index measurement

    15 minutes

Secondary Outcomes (4)

  • maternal outcome

    2 days

  • small for gestationnal age (SGA)

    1 day

  • Apgar Score<7

    1 day

  • distress

    1 day

Study Arms (2)

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

normal PIRADIATION

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

normal PI
pathological PIRADIATION

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

pathological PI

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • gestationnal age \>=34 weeks
  • during labor

You may not qualify if:

  • elective cesarean even if labor
  • non elligible ultrasound criteria of good measurement of uterine artery PI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bougatfa

Bizerte, 7000, Tunisia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25970847BACKGROUND

MeSH Terms

Conditions

Obstetric Labor ComplicationsStillbirthHemorrhage

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • AMIRA AYACHI, Ph D

    University Tunis El Manar

    STUDY CHAIR

Central Study Contacts

AMIRA AYACHI, Ph D

CONTACT

53660148benmrad.amira@yahoo.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Assistant in Obstetrics and gynecology

Study Record Dates

First Submitted

July 24, 2016

First Posted

August 2, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

August 2, 2016

Record last verified: 2016-07

Locations

TU(1)