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Status unknownNCT02853058UADLABUpdated Aug 2, 2016

Uterine Artery Pulsatility Index and Materno Fetal Outcomes

An interventional study of normal PI and pathological PI in Labor Complication, sponsored by University Tunis El Manar. Status unknown at 1 site in Tunisia. Open to female participants. Per ClinicalTrials.gov, last updated 2016-08-02.

Sponsored by University Tunis El Manar · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Non-randomized
Sex
Female
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Study summary

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

Read the 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.

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Conditions studied

  • Labor Complication

Keywords

  • stillbirth
  • hemorrhage
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In context

Obstetric Labor Complications

89 studies on the registry are indexed under Obstetric Labor Complications; 25 are open to participants now.

This study's planned enrollment of 600 is above the median of 150 across 63 interventional studies indexed under Obstetric Labor Complications.

Browse Obstetric Labor Complications studies →

Lead sponsor

University Tunis El Manar is the lead sponsor of 73 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • gestationnal age >=34 weeks
  • during labor

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    normal PI

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

    Radiation: normal PI

  • Active comparator
    pathological PI

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

    Radiation: pathological PI

Interventions

  • Radiationnormal PI

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

  • Radiationpathological PI

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

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What researchers measure

Primary outcomes

  1. right uterine artery pulsatility index measurement

    Time frame: 15 minutes

  2. left uterine artery pulsatility index measurement

    Time frame: 15 minutes

Secondary outcomes

  1. maternal outcome

    number of patients with hemorrhage, preeclampsie, adversal outcomes

    Time frame: 2 days

  2. small for gestationnal age (SGA)

    number of neonatal SGA

    Time frame: 1 day

  3. Apgar Score<7

    number of birth with Apgar score \<7

    Time frame: 1 day

  4. distress

    number of cesarean section for distress

    Time frame: 1 day

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 25970847 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02853058
Lead sponsor
University Tunis El Manar
Responsible party
Amira Ayachi (University Assistant in Obstetrics and gynecology, University Tunis El Manar) — Principal investigator
First posted
Aug 2, 2016
Start date
Jul 2016
Primary completion
Sep 2016 (estimated)
Completion
Nov 2016 (estimated)
Last update
Aug 2, 2016

Study contacts

AMIRA AYACHI, Ph D
Contact
benmrad.amira@yahoo.fr
53660148 ext. 00216
AMIRA AYACHI, Ph D
study chair · University Tunis El Manar

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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