Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, 64460, Mexico
NCT Number: NCT03703037
Objective: To estimate the value of uterine, fetal cerebral Doppler and oligohydramnios to predict abnormal fetal heart rate tracings in pregnancies at or beyond 41 weeks
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Observational
Monterrey, Nuevo León, 64460, Mexico
This will be a nested case-control study that was conducted at University Hospital Dr. Jose E. Gonzalez after the approval of Institutional ethical committee. Women with low risk late term or postterm pregnancy (at least 41 weeks) with confirm gestational age who will be referred to our Maternal-fetal unit and admitted 1 to 2 days prior to induction of labour according institutional protocol will be recruited and constitute the cohort.
Cases will be patients with abnormal intrapartum cardiotocogram (category III fetal heart rate tracing). For each case, four controls will be matched. The primary outcome will be to obtain odds ratios for the Doppler parameters (middle cerebral artery pulsatility index, mean uterine artery pulsatility index and Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio) and amniotic fluid index that would be associated with intrapartum category III fetal heart rate tracing.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Assessment of fetal cerebral and maternal uterine pulsatility index using Doppler ultrasound. Measurement of amniotic fluid index according to four-quadrant technique.
Other names: Pulsatility index, Amniotic fluid index
Time frame: 24 hours
Absent baseline fetal heart rate variability and any of the following: recurrent late decelerations, recurrent variable decelerations, bradycardia, sinusoidal pattern
Time frame: 24 hours before delivery
The middle cerebral artery pulsatility index will be obtained in a transversal view of the fetal head, at the level of its origin from the circle of Willis. Measurements will be obtained during periods of fetal apnea, and the angle of insonation will be maintained as close to 0° as possible when interrogating the middle cerebral artery
Time frame: 24 hours before delivery
The probe will be placed on the lower quadrant of the abdomen, angled medially, and again color Doppler imaging will be used to identify the uterine artery at the apparent crossover with the external iliac artery. Measurements will be taken approximately 1 cm distal to the crossover point. In all cases, once it had been ensured that the angle was less than 20◦, the pulsed Doppler gate will be placed over the whole width of the vessel. Angle correction was then applied and the signal updated until three to five similar consecutive waveforms had been obtained. Mean pulsatility index will be calculated as the average pulsatility index of right and left arteries.
Time frame: 24 hours before delivery
The ratio between the pulsatility index of the middle cerebral artery and the mean pulsatility index value of both uterine arteries.
Time frame: 24 hours before delivery
Amniotic fluid index (Assessed acording to four-quadrant technique)
Hospital Universitario Dr. Jose E. Gonzalez
Other
Clinical Utility of Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Pregnancies at or Beyond 41 Weeks
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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