Uterine Artery Pulsatility Index and Materno Fetal Outcomes

Labor Complication Clinical Trial

— UADLAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02853058
• Other study ID #: UTARTDOP1
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2016
• Last updated: July 28, 2016
• Start date: July 2016
• Est. completion date: November 2016

Study information

• Verified date: July 2016
• Source: University Tunis El Manar
• Contact: AMIRA AYACHI, Ph D
• Phone: 53660148
• Email: benmrad.amira[@]yahoo.fr
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Complication
• Obstetric Labor Complications

Intervention

Radiation:
• normal PI
measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM
• pathological PI
measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM

Locations

Country	Name	City	State
Tunisia	University Hospital Bougatfa	Bizerte

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

Valiño 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	right uterine artery pulsatility index measurement		15 minutes	No
Primary	left uterine artery pulsatility index measurement		15 minutes	No
Secondary	maternal outcome	number of patients with hemorrhage, preeclampsie, adversal outcomes	2 days	No
Secondary	small for gestationnal age (SGA)	number of neonatal SGA	1 day	No
Secondary	Apgar Score<7	number of birth with Apgar score <7	1 day	No
Secondary	distress	number of cesarean section for distress	1 day	No