Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Postterm Pregnancies

Overview

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

Full Title of Study: “Clinical Utility of Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Pregnancies at or Beyond 41 Weeks”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 1, 2019

Detailed Description

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.

Interventions

  • Diagnostic Test: Ultrasound and Doppler ultrasound
    • Assessment of fetal cerebral and maternal uterine pulsatility index using Doppler ultrasound. Measurement of amniotic fluid index according to four-quadrant technique.

Arms, Groups and Cohorts

  • Cohort
    • This will be a nested case-control study. Women with low risk pregnancies at or beyond 41 weeks, who will be referred to our Maternal-fetal unit and admitted 1 to 2 days prior to induction of labour according institutional protocol will constitute the cohort. Then women with intrapartum abnormal fetal heart rate tracings (cases) will be identified and match with controls. The primary outcome will be to obtain odds ratios for the Doppler ultrasound 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 Ultrasound assessment of amniotic fluid index that would be associated with intrapartum category III fetal heart rate tracing.
  • Cases
    • Cases will be patients with abnormal intrapartum cardiotocogram (category III fetal heart rate tracing). Intervention: Ultrasound and Doppler ultrasound
  • Controls
    • Those will be patients with normal intrapartum cardiotocogram (category I fetal heart rate tracing) or category II that converted into category I after intrauterine resuscitation methods. Intervention: Ultrasound and Doppler ultrasound

Clinical Trial Outcome Measures

Primary Measures

  • Category III fetal heart rate tracings
    • Time Frame: 24 hours
    • Absent baseline fetal heart rate variability and any of the following: recurrent late decelerations, recurrent variable decelerations, bradycardia, sinusoidal pattern

Secondary Measures

  • Middle cerebral artery pulsatility index
    • 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
  • Mean uterine artery pulsatility index
    • 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.
  • Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio
    • 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.
  • Oligohydramnios
    • Time Frame: 24 hours before delivery
    • Amniotic fluid index (Assessed acording to four-quadrant technique)

Participating in This Clinical Trial

Inclusion Criteria

  • Singleton pregnancy – Gestational age of at least 287 days (41 weeks) – Low risk pregnancy (defined as the absence of maternal or fetal complications other than postterm pregnancy) Exclusion Criteria:

  • Twin or multiple gestation – Uncertain gestational age – Non vertex presentation – Estimated fetal weight below the 10th percentile for gestational age (Hadlock´s formula) – Fetal macrosomia (estimated fetal weight ≥ 4 Kilos) diagnosed by clinical measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula). – Fetal abnormalities found on routine anomaly scan. – Maternal medical disorder (preeclampsia, chronic hypertension, diabetes, lupus, hyperthyroidism) – Prelabour rupture of membranes – Antepartum hemorrhage – Any fetopelvic disproportion that could create dystocia during labor.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospital Universitario Dr. Jose E. Gonzalez
  • Provider of Information About this Clinical Study
    • Principal Investigator: Flavio Hernández Castro, Principal investigator Flavio Hernández Castro MD PhD – Hospital Universitario Dr. Jose E. Gonzalez
  • Overall Official(s)
    • Flavio Hernández-Castro, MD PhD, Principal Investigator, Hospital Universitario Dr. José Eleuterio González UANL

References

Lebovitz O, Barzilay E, Mazaki-Tovi S, Gat I, Achiron R, Gilboa Y. The clinical value of maternal and fetal Doppler parameters in low-risk postdates pregnancies – a prospective study. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2893-2897. doi: 10.1080/14767058.2017.1359531. Epub 2017 Aug 9.

Lam H, Leung WC, Lee CP, Lao TT. The use of fetal Doppler cerebroplacental blood flow and amniotic fluid volume measurement in the surveillance of postdated pregnancies. Acta Obstet Gynecol Scand. 2005 Sep;84(9):844-8. doi: 10.1111/j.0001-6349.2005.00741.x.

Arabin B, Becker R, Mohnhaupt A, Vollert W, Weitzel HK. Prediction of fetal distress and poor outcome in prolonged pregnancy using Doppler ultrasound and fetal heart rate monitoring combined with stress tests (II). Fetal Diagn Ther. 1994 Jan-Feb;9(1):1-6. doi: 10.1159/000263899.

Tongsong T, Srisomboon J. Amniotic fluid volume as a predictor of fetal distress in postterm pregnancy. Int J Gynaecol Obstet. 1993 Mar;40(3):213-7. doi: 10.1016/0020-7292(93)90833-i.

Adiga P, Kantharaja I, Hebbar S, Rai L, Guruvare S, Mundkur A. Predictive value of middle cerebral artery to uterine artery pulsatility index ratio in hypertensive disorders of pregnancy. Int J Reprod Med. 2015;2015:614747. doi: 10.1155/2015/614747. Epub 2015 Feb 1.

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