Clinical trial NCT06761794: Normogram of Umbilical Artery and Fetal Middle Cerebral Artery Doppler Indices in Upper Egyptian Women
Official title: Normogram of Umbilical Artery and Fetal Middle Cerebral Artery Doppler Indices in Upper Egyptian Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Doppler in Normal Pregnancy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 520
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with gestational age 15-40 wk, singleton fetus with no anomalies, free of medical and obstetric complications.

Brief summary: settle umbilical and fetal middle cerebral arteries Doppler indices( pulsatility index and resistive index) in normal pregnancy to generate a local reference range and calculate cerebroplacental ratio.


Eligibility criteria: Inclusion Criteria:

1. Singleton pregnancy between 15 and 40 weeks gestational age.
2. Sure of her date (well-known LMP or confirmed date by an early ultrasound).
3. Normal fetal anatomy.
4. No history of medical disorders.

Exclusion Criteria:

1. Multiple pregnancy
2. Fetal anomalies.
3. Associated medical disorders.
4. Obstetric complications.

Primary outcomes:
measure: pulsatility index of umbilical artery.
timeFrame: Through study completion, an average of 1 year
measure: Resistive index of umbilical artery
timeFrame: Through study completion, an average of 1 year
measure: pulsatility index of fetal middle cerebral artery.
timeFrame: Through study completion, an average of 1 year
measure: Resistive index of fetal middle cerebral artery
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: settle cerebroplacental ratio local reference range.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Acharya G, Wilsgaard T, Berntsen GK, Maltau JM, Kiserud T. Reference ranges for serial measurements of umbilical artery Doppler indices in the second half of pregnancy. Am J Obstet Gynecol. 2005 Mar;192(3):937-44. doi: 10.1016/j.ajog.2004.09.019.
citation: Mari G. Middle cerebral artery peak systolic velocity for the diagnosis of fetal anemia: the untold story. Ultrasound Obstet Gynecol. 2005 Apr;25(4):323-30. doi: 10.1002/uog.1882. No abstract available.
citation: Ebbing C, Rasmussen S, Kiserud T. Middle cerebral artery blood flow velocities and pulsatility index and the cerebroplacental pulsatility ratio: longitudinal reference ranges and terms for serial measurements. Ultrasound Obstet Gynecol. 2007 Sep;30(3):287-96. doi: 10.1002/uog.4088.
citation: Maulik D, Mundy D, Heitmann E, Maulik D. Umbilical artery Doppler in the assessment of fetal growth restriction. Clin Perinatol. 2011 Mar;38(1):65-82, vi. doi: 10.1016/j.clp.2010.12.004.
citation: Tarzamni MK, Nezami N, Gatreh-Samani F, Vahedinia S, Tarzamni M. Doppler waveform indices of fetal middle cerebral artery in normal 20 to 40 weeks pregnancies. Arch Iran Med. 2009 Jan;12(1):29-34.
citation: Dubiel M, Breborowicz GH, Marsal K, Gudmundsson S. Fetal adrenal and middle cerebral artery Doppler velocimetry in high-risk pregnancy. Ultrasound Obstet Gynecol. 2000 Oct;16(5):414-8. doi: 10.1046/j.1469-0705.2000.00278.x.