Labor ComplicationUADLABNCT02853058
Uterine Artery Pulsatility Index and Materno Fetal Outcomes
A study testing normal PI and pathological PI in people with Labor Complication, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
High Uterine artery index pulsatility (PI) is associated with small for gestationnal age but also with stillbirth and distress during labor. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labor Complication
- What is being tested?
- normal PI and pathological PI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTunisia
- Study dates
- Jul 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- gestationnal age >=34 weeks
- during labor
Who cannot join
- elective cesarean even if labor
- non elligible ultrasound criteria of good measurement of uterine artery PI
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
University Hospital Bougatfa
Bizerte, 7000
AMIRA AYACHI, Ph D, 53660148 ext. 00216, benmrad.amira@yahoo.fr
Mechaal mouurali, professor, 98693968 ext. 00216, mouralimech@yaho.fr
About this study
Official title: 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.
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.
- Conditions
- Labor Complication
- Being tested
- normal PI, pathological PI
- Keywords
- stillbirth, hemorrhage
- Medical subject headings
- Obstetric Labor Complications, Stillbirth, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal PIRadiation
measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM
pathological PIRadiation
measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM
| Study group | Role | What they receive |
|---|---|---|
| normal PI | Active comparator | Uterine artery PI expresserd in MoM is <95e percentile Receives: Radiation: normal PI |
| pathological PI | Active comparator | Uterine artery PI expressed in Multiple of Mediane (MoM) is >=95e percentile Receives: Radiation: pathological PI |
What is being measured
The primary outcome is the main question the study is designed to answer.
right uterine artery pulsatility index measurement
Measured: 15 minutes
left uterine artery pulsatility index measurement
Measured: 15 minutes
Secondary outcomes (4)
maternal outcome
number of patients with hemorrhage, preeclampsie, adversal outcomes
Measured: 2 days
small for gestationnal age (SGA)
number of neonatal SGA
Measured: 1 day
Apgar Score<7
number of birth with Apgar score <7
Measured: 1 day
distress
number of cesarean section for distress
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ayachi, University Tunis El Manar
- Investigators
- AMIRA AYACHI, Ph D, Study chair, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853058
- Sponsor's protocol ID
- UTARTDOP1
- Acronym
- UADLAB
- Status last verified
- Jul 2016
- First submitted
- 24 Jul 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Artery Pulsatility Index During Labor After 34 Weeks in the Prediction of Materno Fetal Outcomes
- ClinicalTrials.gov ID
- NCT02853058
- Acronym / sponsor ID
- UADLAB / UTARTDOP1
- Conditions
- Labor Complication
- Keywords
- stillbirth, hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High Uterine artery index pulsatility (PI) is associated with small for gestationnal age but also with stillbirth and distress during labor.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal PI | Active comparator | Radiation: normal PIUterine artery PI expresserd in MoM is <95e percentile |
| pathological PI | Active comparator | Radiation: pathological PIUterine artery PI expressed in Multiple of Mediane (MoM) is >=95e percentile |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- gestationnal age >=34 weeks
- during labor
Key exclusion criteria (2 listed)
- elective cesarean even if labor
- non elligible ultrasound criteria of good measurement of uterine artery PI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal PImeasurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM | Radiation | normal PI |
| pathological PImeasurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM | Radiation | pathological PI |
Primary outcome
right uterine artery pulsatility index measurement
Time frame: 15 minutes
left uterine artery pulsatility index measurement
Time frame: 15 minutes
4 secondary outcomes
maternal outcome
Time frame: 2 days
small for gestationnal age (SGA)
Time frame: 1 day
Apgar Score<7
Time frame: 1 day
distress
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
- Background: PubMed 25970847Valino 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AMIRA AYACHI, Ph D study chair
University Tunis El Manar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal PI and pathological PI in people with Labor Complication, run by University Tunis El Manar at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AMIRA AYACHI, Ph D (53660148 ext. 00216, benmrad.amira@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
right uterine artery pulsatility index measurement (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02853058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016.