Uterine Artery Pulsatility Index and Materno Fetal Outcomes (UADLAB)

July 28, 2016 updated by: Amira Ayachi, University Tunis El Manar

Uterine Artery Pulsatility Index During Labor After 34 Weeks in the Prediction of Materno Fetal Outcomes

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tunisia
      • Bizerte, Tunisia, 7000
        • Recruiting
        • University Hospital Bougatfa
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: normal PI
Uterine artery PI expresserd in MoM is <95e percentile
Radiation: normal PI
measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM
Active Comparator: pathological PI
Uterine artery PI expressed in Multiple of Mediane (MoM) is >=95e percentile
Radiation: pathological PI
measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal outcome
Time Frame: 2 days
number of patients with hemorrhage, preeclampsie, adversal outcomes
2 days
small for gestationnal age (SGA)
Time Frame: 1 day
number of neonatal SGA
1 day
Apgar Score<7
Time Frame: 1 day
number of birth with Apgar score <7
1 day
distress
Time Frame: 1 day
number of cesarean section for distress
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Tunis El Manar

Investigators

  • Study Chair: AMIRA AYACHI, Ph D, University Tunis El Manar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

July 24, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Estimate)

August 2, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTARTDOP1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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